{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T12:38:13Z","timestamp":1793450293372,"version":"4.5.0"},"reference-count":154,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Psychiatry"],"published-print":{"date-parts":[[2026,7,1]]},"abstract":"\n Importance<\/jats:title>\n Psychedelic drugs possess acute psychoactive effects that can compromise blinding integrity in randomized clinical trials (RCTs). Functional unblinding, when participants or raters correctly identify treatment allocation based on subjective effects, may bias outcomes through expectancy effects, challenging the validity of efficacy estimates and regulatory acceptance.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To systematically quantify the prevalence of blinding integrity assessment and the extent of functional unblinding in psychedelic RCTs for psychiatric disorders.<\/jats:p>\n <\/jats:sec>\n \n Evidence Review<\/jats:title>\n A systematic review was conducted in accordance with PRISMA guidelines across OVID, MEDLINE, Embase, and APA PsycINFO (January 1, 2020, to December 11, 2025), supplemented by manual searches of 3 prior reviews for studies prior to January 2020. Eligible studies included all RCTs investigating psychedelics as psychiatric interventions. Data extracted included blinding integrity assessment methods and results for participants and raters.<\/jats:p>\n <\/jats:sec>\n \n Findings<\/jats:title>\n \n Of 112 RCTs (11 psilocybin, 17 lysergic acid diethylamide [LSD], 78 ketamine, 11 3,4-methylenedioxymethamphetamine [MDMA], 2 ayahuasca, 2\n N<\/jats:italic>\n ,\n N<\/jats:italic>\n -dimethyltryptamine [DMT], and 1 noribogaine), only 29.5% (n\u2009=\u200933) evaluated blinding integrity, yet 57.1% (n\u2009=\u200964) cited blinding as a limitation. Functional unblinding was substantial: psilocybin, LSD, and ayahuasca studies frequently reported blinding failure values of more than 90% among participants and raters, inert placebo-controlled MDMA trials exceeded 85%, and ketamine trials rarely assessed blinding (17.9%) but showed improved preservation with midazolam vs saline controls. No control strategy consistently achieved ideal blinding.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n This first evaluation of blinding integrity in psychedelic RCTs indicates functional unblinding is pervasive among participants and raters raising concerns about the validity of efficacy findings. Few trials assess blinding or expectancy, highlighting the need for standardized, validated measures and innovative designs to separate true pharmacological effects from expectancy-driven responses.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamapsychiatry.2026.0255","type":"journal-article","created":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T15:30:35Z","timestamp":1776267035000},"page":"755","source":"Crossref","is-referenced-by-count":18,"title":["Blinding Integrity in Psychedelic Randomized Clinical Trials"],"prefix":"10.1001","volume":"83","author":[{"given":"Diana K.","family":"Orsini","sequence":"first","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina","family":"Wong","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Di Luch","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brendan","family":"Chan","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shreya","family":"Vasudeva","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabrielle F. M.","family":"Lovell","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gia Han","family":"Le","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brett D. M.","family":"Jones","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"},{"name":"Centre for Addiction and Mental Health, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noah","family":"Chisamore","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriano","family":"Mollica","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"},{"name":"Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danica E.","family":"Johnson","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica S.","family":"Kaczmarek","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akash","family":"Goel","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology & Pain Medicine, University of Toronto, Toronto, Ontario, Canada"},{"name":"Department of Anesthesia and Pain Medicine, St Michael\u2019s Hospital, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Burke","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"},{"name":"Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada"},{"name":"Department of Psychiatry, Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodrigo","family":"Mansur","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger S.","family":"McIntyre","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"},{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Ishrat","family":"Husain","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"},{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"},{"name":"Centre for Addiction and Mental Health, Toronto, Ontario, Canada"},{"name":"Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua D.","family":"Rosenblat","sequence":"additional","affiliation":[{"name":"Poul Hansen Family Centre for Depression, Krembil Brain Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Pharmacology and Toxicology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"},{"name":"Department of Psychiatry, University of Toronto, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"11","key":"yrv260003r1","doi-asserted-by":"publisher","first-page":"2105","DOI":"10.1038\/npp.2017.84","article-title":"The Therapeutic potential of psychedelic drugs: past, present, and future.","volume":"42","author":"Carhart-Harris","year":"2017","journal-title":"Neuropsychopharmacology"},{"issue":"1","key":"yrv260003r2","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1038\/s41386-023-01656-7","article-title":"Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.","volume":"49","author":"Mitchell","year":"2024","journal-title":"Neuropsychopharmacology"},{"issue":"5","key":"yrv260003r3","doi-asserted-by":"publisher","first-page":"512","DOI":"10.1016\/j.bpsc.2024.02.004","article-title":"Expectancy effects in psychedelic trials.","volume":"9","author":"Szigeti","year":"2024","journal-title":"Biol Psychiatry Cogn Neurosci Neuroimaging"},{"issue":"9","key":"yrv260003r4","doi-asserted-by":"publisher","first-page":"1133","DOI":"10.1080\/17512433.2021.1933434","article-title":"Blinding and expectancy confounds in psychedelic randomized controlled trials.","volume":"14","author":"Muthukumaraswamy","year":"2021","journal-title":"Expert Rev Clin Pharmacol"},{"issue":"10","key":"yrv260003r5","doi-asserted-by":"publisher","first-page":"2473","DOI":"10.1038\/s41591-023-02565-4","article-title":"MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial.","volume":"29","author":"Mitchell","year":"2023","journal-title":"Nat Med"},{"issue":"10","key":"yrv260003r6","doi-asserted-by":"publisher","first-page":"1687","DOI":"10.1038\/s41591-021-01524-1","article-title":"Caution at psychiatry\u2019s psychedelic frontier.","volume":"27","author":"Burke","year":"2021","journal-title":"Nat Med"},{"issue":"4","key":"yrv260003r7","doi-asserted-by":"publisher","first-page":"204","DOI":"10.1159\/000490354","article-title":"Implications of placebo and nocebo effects for clinical practice: expert consensus.","volume":"87","author":"Evers","year":"2018","journal-title":"Psychother Psychosom"},{"issue":"3","key":"yrv260003r8","doi-asserted-by":"publisher","first-page":"246","DOI":"10.1177\/1740774510367916","article-title":"Participant expectancies in double-blind randomized placebo-controlled trials: potential limitations to trial validity.","volume":"7","author":"Colagiuri","year":"2010","journal-title":"Clin Trials"},{"key":"yrv260003r9","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-078607","article-title":"Comparative oral monotherapy of psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine, ayahuasca, and escitalopram for depressive symptoms: systematic review and Bayesian network meta-analysis.","volume":"386","author":"Hsu","year":"2024","journal-title":"BMJ"},{"key":"yrv260003r10","doi-asserted-by":"publisher","DOI":"10.1038\/d41586-024-01622-3","article-title":"MDMA therapy for PTSD rejected by FDA panel.","author":"Reardon","year":"2024","journal-title":"Nature"},{"key":"yrv260003r11","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n160","article-title":"PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews.","author":"Page","journal-title":"BMJ"},{"issue":"9760","key":"yrv260003r12","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1016\/S0140-6736(10)60903-8","article-title":"An international registry of systematic-review protocols.","volume":"377","author":"Booth","year":"2011","journal-title":"Lancet"},{"key":"yrv260003r13","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.102127","article-title":"Ketamine for the treatment of major depression: a systematic review and meta-analysis.","volume":"62","author":"Nikolin","year":"2023","journal-title":"EClinicalMedicine"},{"issue":"4","key":"yrv260003r14","doi-asserted-by":"publisher","first-page":"672","DOI":"10.1002\/npr2.12485","article-title":"MDMA-assisted psychotherapy for the treatment of PTSD: a systematic review and meta-analysis of randomized controlled trials (RCTs).","volume":"44","author":"Shahrour","year":"2024","journal-title":"Neuropsychopharmacol Rep"},{"issue":"3","key":"yrv260003r15","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.22r14518","article-title":"Control conditions in randomized trials of psychedelics: an ACTTION systematic review.","volume":"84","author":"Nayak","year":"2023","journal-title":"J Clin Psychiatry"},{"issue":"2","key":"yrv260003r17","doi-asserted-by":"publisher","first-page":"R63","DOI":"10.1016\/j.cub.2021.12.009","article-title":"Psychedelics.","volume":"32","author":"Kelmendi","year":"2022","journal-title":"Curr Biol"},{"issue":"8","key":"yrv260003r18","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0012412","article-title":"Psychometric evaluation of the altered states of consciousness rating scale (OAV).","volume":"5","author":"Studerus","year":"2010","journal-title":"PLoS One"},{"issue":"5","key":"yrv260003r19","doi-asserted-by":"publisher","first-page":"891","DOI":"10.1523\/JNEUROSCI.1659-20.2020","article-title":"Hallucinogens in mental health: preclinical and clinical studies on LSD, psilocybin, MDMA, and ketamine.","volume":"41","author":"De Gregorio","year":"2021","journal-title":"J Neurosci"},{"issue":"9","key":"yrv260003r20","doi-asserted-by":"publisher","first-page":"784","DOI":"10.1176\/appi.ajp.20240644","article-title":"Ketamine, the first associative anesthetic? some considerations on classifying psychedelics, entactogens, and dissociatives.","volume":"181","author":"Denomme","year":"2024","journal-title":"Am J Psychiatry"},{"issue":"1","key":"yrv260003r21","doi-asserted-by":"publisher","first-page":"104","DOI":"10.1038\/s41386-023-01666-5","article-title":"Therapeutic mechanisms of psychedelics and entactogens.","volume":"49","author":"Heifets","year":"2024","journal-title":"Neuropsychopharmacology"},{"key":"yrv260003r22","doi-asserted-by":"publisher","first-page":"l4898","DOI":"10.1136\/bmj.l4898","article-title":"RoB 2: a revised tool for assessing risk of bias in randomised trials.","volume":"366","author":"Sterne","year":"2019","journal-title":"BMJ"},{"issue":"10","key":"yrv260003r23","doi-asserted-by":"publisher","first-page":"953","DOI":"10.1001\/jamapsychiatry.2022.2096","article-title":"Percentage of heavy drinking days following psilocybin-assisted psychotherapy vs placebo in the treatment of adult patients with alcohol use disorder: a randomized clinical trial.","volume":"79","author":"Bogenschutz","year":"2022","journal-title":"JAMA Psychiatry"},{"issue":"12","key":"yrv260003r24","doi-asserted-by":"publisher","first-page":"1181","DOI":"10.1177\/0269881116675513","article-title":"Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial.","volume":"30","author":"Griffiths","year":"2016","journal-title":"J Psychopharmacol"},{"key":"yrv260003r25","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2025.103149","article-title":"Psilocybin-assisted therapy for relapse prevention in alcohol use disorder: a phase 2 randomized clinical trial.","volume":"82","author":"Rieser","year":"2025","journal-title":"EClinicalMedicine"},{"issue":"15","key":"yrv260003r26","doi-asserted-by":"publisher","first-page":"1402","DOI":"10.1056\/NEJMoa2032994","article-title":"Trial of psilocybin versus escitalopram for depression.","volume":"384","author":"Carhart-Harris","year":"2021","journal-title":"N Engl J Med"},{"issue":"18","key":"yrv260003r27","doi-asserted-by":"publisher","first-page":"1637","DOI":"10.1056\/NEJMoa2206443","article-title":"Single-dose psilocybin for a treatment-resistant episode of major depression.","volume":"387","author":"Goodwin","year":"2022","journal-title":"N Engl J Med"},{"issue":"12","key":"yrv260003r28","doi-asserted-by":"publisher","first-page":"1165","DOI":"10.1177\/0269881116675512","article-title":"Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial.","volume":"30","author":"Ross","year":"2016","journal-title":"J Psychopharmacol"},{"issue":"7","key":"yrv260003r29","doi-asserted-by":"publisher","first-page":"698","DOI":"10.1177\/02698811231154852","article-title":"Psilocybin-assisted therapy for major depressive disorder: an exploratory placebo-controlled, fixed-order trial.","volume":"37","author":"Sloshower","year":"2023","journal-title":"J Psychopharmacol"},{"issue":"1","key":"yrv260003r30","doi-asserted-by":"publisher","first-page":"71","DOI":"10.1001\/archgenpsychiatry.2010.116","article-title":"Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer.","volume":"68","author":"Grob","year":"2011","journal-title":"Arch Gen Psychiatry"},{"issue":"9","key":"yrv260003r31","doi-asserted-by":"publisher","first-page":"843","DOI":"10.1001\/jama.2023.14530","article-title":"Single-dose psilocybin treatment for major depressive disorder: a randomized clinical trial.","volume":"330","author":"Raison","year":"2023","journal-title":"JAMA"},{"key":"yrv260003r32","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2022.101809","article-title":"Single-dose psilocybin-assisted therapy in major depressive disorder: a placebo-controlled, double-blind, randomised clinical trial.","volume":"56","author":"von Rotz","year":"2022","journal-title":"EClinicalMedicine"},{"key":"yrv260003r33","doi-asserted-by":"publisher","DOI":"10.1111\/add.70152","article-title":"Psilocybin in alcohol use disorder and comorbid depressive symptoms: results from a feasibility randomized clinical trial.","author":"Luquiens","journal-title":"Addiction"},{"issue":"6","key":"yrv260003r34","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1007\/BF00402365","article-title":"Reaction time (\u201cmental set\u201d) in control and chronic schizophrenic subjects and in postaddicts under placebo, LSD-25, morphine, pentobarbital and amphetamine.","volume":"7","author":"Wikler","year":"1965","journal-title":"Psychopharmacologia"},{"issue":"3","key":"yrv260003r35","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1016\/j.biopsych.2022.08.025","article-title":"Lysergic acid diethylamide-assisted therapy in patients with anxiety with and without a life-threatening illness: a randomized, double-blind, placebo-controlled phase II study.","volume":"93","author":"Holze","year":"2023","journal-title":"Biol Psychiatry"},{"issue":"7","key":"yrv260003r36","doi-asserted-by":"publisher","first-page":"513","DOI":"10.1097\/NMD.0000000000000113","article-title":"Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases.","volume":"202","author":"Gasser","year":"2014","journal-title":"J Nerv Ment Dis"},{"key":"yrv260003r37","doi-asserted-by":"publisher","DOI":"10.1016\/j.medj.2025.100725","article-title":"Efficacy and safety of low- versus high-dose-LSD-assisted therapy in patients with major depression: a randomized trial.","author":"M\u00fcller","journal-title":"Med"},{"issue":"6","key":"yrv260003r38","doi-asserted-by":"publisher","first-page":"653","DOI":"10.1001\/archpsyc.1964.01720240107012","article-title":"Tolerance to LSD-25 in schizophrenic subjects: attenuation of effects on pupillary diameter and kneejerk threshold after chronic intoxication.","volume":"10","author":"Chessick","year":"1964","journal-title":"Arch Gen Psychiatry"},{"issue":"4","key":"yrv260003r39","doi-asserted-by":"publisher","first-page":"932","DOI":"10.15288\/qjsa.1970.31.932","article-title":"Lysergide treatment of schizophrenic and nonschizophrenic alcoholics: a controlled evaluation.","volume":"31","author":"Tomsovic","year":"1970","journal-title":"Q J Stud Alcohol"},{"issue":"1","key":"yrv260003r40","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1007\/BF00404164","article-title":"Age and effect of LSD-25 on pupil size and kneejerk threshold. Studies in chronic schizophrenic and nonpsychotic subjects.","volume":"7","author":"Wikler","year":"1965","journal-title":"Psychopharmacologia"},{"issue":"8","key":"yrv260003r41","doi-asserted-by":"publisher","first-page":"1574","DOI":"10.1038\/s41386-022-01266-9","article-title":"Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial.","volume":"47","author":"Abdallah","year":"2022","journal-title":"Neuropsychopharmacology"},{"issue":"5","key":"yrv260003r42","doi-asserted-by":"publisher","first-page":"521","DOI":"10.1177\/00912174231225087","article-title":"Comparison of ketamine with buprenorphine as adjunctive therapy in the treatment of comorbid major depressive disorder and opium use disorders: a randomized controlled trial.","volume":"59","author":"Ahmadi","year":"2024","journal-title":"Int J Psychiatry Med"},{"key":"yrv260003r43","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1016\/j.jad.2023.01.005","article-title":"Antidepressant and anti-suicidal effects of ketamine in treatment-resistant depression associated with psychiatric and personality comorbidities: a double-blind randomized trial.","volume":"325","author":"Ahmed","year":"2023","journal-title":"J Affect Disord"},{"key":"yrv260003r44","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1016\/j.jad.2018.02.056","article-title":"Does oral administration of ketamine accelerate response to treatment in major depressive disorder? Results of a double-blind controlled trial.","volume":"235","author":"Arabzadeh","year":"2018","journal-title":"J Affect Disord"},{"issue":"4","key":"yrv260003r45","doi-asserted-by":"publisher","first-page":"351","DOI":"10.1016\/S0006-3223(99)00230-9","article-title":"Antidepressant effects of ketamine in depressed patients.","volume":"47","author":"Berman","year":"2000","journal-title":"Biol Psychiatry"},{"issue":"8","key":"yrv260003r46","doi-asserted-by":"publisher","first-page":"784","DOI":"10.1177\/02698811231189432","article-title":"Ketamine-induced changes in resting state connectivity, 2 h after the drug administration in patients with remitted depression.","volume":"37","author":"Burrows","year":"2023","journal-title":"J Psychopharmacol"},{"issue":"7","key":"yrv260003r47","doi-asserted-by":"publisher","first-page":"620","DOI":"10.1176\/appi.ajp.2018.17060720","article-title":"Efficacy and Safety of intranasal esketamine for the rapid reduction of symptoms of depression and suicidality in patients at imminent risk for suicide: results of a double-blind, randomized, placebo-controlled study.","volume":"175","author":"Canuso","year":"2018","journal-title":"Am J Psychiatry"},{"issue":"6","key":"yrv260003r48","doi-asserted-by":"publisher","first-page":"1668","DOI":"10.1109\/TBME.2018.2877651","article-title":"Identifying ketamine responses in treatment-resistant depression using a wearable forehead EEG.","volume":"66","author":"Zehong","year":"2019","journal-title":"IEEE Trans Biomed Eng"},{"key":"yrv260003r49","doi-asserted-by":"publisher","first-page":"709","DOI":"10.1016\/j.jad.2017.09.008","article-title":"Persistent antidepressant effect of low-dose ketamine and activation in the supplementary motor area and anterior cingulate cortex in treatment-resistant depression: a randomized control study.","volume":"225","author":"Chen","year":"2018","journal-title":"J Affect Disord"},{"key":"yrv260003r50","doi-asserted-by":"publisher","first-page":"693","DOI":"10.2147\/NDT.S391096","article-title":"Efficacy and safety of flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant in adult patients with treatment-resistant depression: a randomized, double-blind, multicenter, active-controlled study conducted in China and USA.","volume":"19","author":"Chen","year":"2023","journal-title":"Neuropsychiatr Dis Treat"},{"key":"yrv260003r51","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1016\/j.jpsychires.2024.03.002","article-title":"Oral prolonged-release ketamine in treatment-resistant depression\u2014a double-blind randomized placebo-controlled multicentre trial of KET01, a novel ketamine formulation\u2014clinical and safety results.","volume":"173","author":"Colla","year":"2024","journal-title":"J Psychiatr Res"},{"key":"yrv260003r52","doi-asserted-by":"publisher","first-page":"527","DOI":"10.1016\/j.jad.2019.11.086","article-title":"Efficacy and safety of adjunctive therapy using esketamine or racemic ketamine for adult treatment-resistant depression: a randomized, double-blind, non-inferiority study.","volume":"264","author":"Correia-Melo","year":"2020","journal-title":"J Affect Disord"},{"issue":"2","key":"yrv260003r53","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1176\/appi.ajp.2019.19070684","article-title":"A single ketamine infusion combined with motivational enhancement therapy for alcohol use disorder: a randomized midazolam-controlled pilot trial.","volume":"177","author":"Dakwar","year":"2020","journal-title":"Am J Psychiatry"},{"issue":"2","key":"yrv260003r54","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1001\/jamapsychiatry.2017.3739","article-title":"Efficacy and safety of intranasal esketamine adjunctive to oral antidepressant therapy in treatment-resistant depression: a randomized clinical trial.","volume":"75","author":"Daly","year":"2018","journal-title":"JAMA Psychiatry"},{"issue":"8","key":"yrv260003r55","doi-asserted-by":"publisher","first-page":"793","DOI":"10.1001\/archgenpsychiatry.2010.90","article-title":"A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression.","volume":"67","author":"Diazgranados","year":"2010","journal-title":"Arch Gen Psychiatry"},{"issue":"5","key":"yrv260003r56","doi-asserted-by":"publisher","first-page":"614","DOI":"10.1177\/02698811221078764","article-title":"The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder.","volume":"36","author":"Dijkstra","year":"2022","journal-title":"J Psychopharmacol"},{"issue":"1","key":"yrv260003r57","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1192\/bjp.2018.196","article-title":"Repeated oral ketamine for out-patient treatment of resistant depression: randomised, double-blind, placebo-controlled, proof-of-concept study.","volume":"214","author":"Domany","year":"2019","journal-title":"Br J Psychiatry"},{"issue":"3","key":"yrv260003r58","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1002\/da.22975","article-title":"Ketamine for acute suicidal ideation. An emergency department intervention: a randomized, double-blind, placebo-controlled, proof-of-concept trial.","volume":"37","author":"Domany","year":"2020","journal-title":"Depress Anxiety"},{"issue":"6","key":"yrv260003r59","doi-asserted-by":"publisher","first-page":"994","DOI":"10.1016\/j.euroneuro.2016.03.006","article-title":"Comparing the actions of lanicemine and ketamine in depression: key role of the anterior cingulate.","volume":"26","author":"Downey","year":"2016","journal-title":"Eur Neuropsychopharmacol"},{"issue":"4","key":"yrv260003r60","doi-asserted-by":"publisher","first-page":"352","DOI":"10.1176\/appi.ajp.2020.20010018","article-title":"Efficacy of intravenous ketamine in adolescent treatment-resistant depression: a randomized midazolam-controlled trial.","volume":"178","author":"Dwyer","year":"2021","journal-title":"Am J Psychiatry"},{"issue":"7","key":"yrv260003r61","doi-asserted-by":"publisher","first-page":"1592","DOI":"10.1038\/s41380-018-0256-5","article-title":"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","volume":"25","author":"Fava","year":"2020","journal-title":"Mol Psychiatry"},{"issue":"6","key":"yrv260003r62","doi-asserted-by":"publisher","first-page":"681","DOI":"10.1001\/jamapsychiatry.2014.62","article-title":"Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial.","volume":"71","author":"Feder","year":"2014","journal-title":"JAMA Psychiatry"},{"issue":"2","key":"yrv260003r63","doi-asserted-by":"publisher","first-page":"193","DOI":"10.1176\/appi.ajp.2020.20050596","article-title":"A randomized controlled trial of repeated ketamine administration for chronic posttraumatic stress disorder.","volume":"178","author":"Feder","year":"2021","journal-title":"Am J Psychiatry"},{"issue":"10","key":"yrv260003r64","doi-asserted-by":"publisher","first-page":"616","DOI":"10.1093\/ijnp\/pyz039","article-title":"Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1).","volume":"22","author":"Fedgchin","year":"2019","journal-title":"Int J Neuropsychopharmacol"},{"issue":"7","key":"yrv260003r65","doi-asserted-by":"publisher","first-page":"991","DOI":"10.1038\/s41386-023-01540-4","article-title":"A pilot randomized controlled trial of ketamine in borderline personality disorder.","volume":"48","author":"Fineberg","year":"2023","journal-title":"Neuropsychopharmacology"},{"key":"yrv260003r66","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.19m13191","article-title":"Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I).","author":"Fu","year":"2020","journal-title":"J Clin Psychiatry"},{"issue":"4","key":"yrv260003r68","doi-asserted-by":"publisher","first-page":"397","DOI":"10.1177\/0269881118760660","article-title":"Repeated intranasal ketamine for treatment-resistant depression\u2014the way to go? Results from a pilot randomised controlled trial.","volume":"32","author":"G\u00e1lvez","year":"2018","journal-title":"J Psychopharmacol"},{"issue":"6","key":"yrv260003r69","doi-asserted-by":"publisher","first-page":"541","DOI":"10.1177\/02698811241254834","article-title":"Esketamine combined with a mindfulness-based intervention for individuals with alcohol problems.","volume":"38","author":"Gent","year":"2024","journal-title":"J Psychopharmacol"},{"issue":"11","key":"yrv260003r70","doi-asserted-by":"publisher","first-page":"1199","DOI":"10.1016\/j.jagp.2017.06.007","article-title":"Pilot randomized controlled trial of titrated subcutaneous ketamine in older patients with treatment-resistant depression.","volume":"25","author":"George","year":"2017","journal-title":"Am J Geriatr Psychiatry"},{"issue":"3","key":"yrv260003r71","doi-asserted-by":"publisher","first-page":"267","DOI":"10.1177\/0269881119874457","article-title":"Effects of ketamine in patients with treatment-refractory generalized anxiety and social anxiety disorders: exploratory double-blind psychoactive-controlled replication study.","volume":"34","author":"Glue","year":"2020","journal-title":"J Psychopharmacol"},{"issue":"2","key":"yrv260003r72","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1177\/02698811241227026","article-title":"Ketamine for treatment-resistant major depressive disorder: double-blind active-controlled crossover study.","volume":"38","author":"Glue","year":"2024","journal-title":"J Psychopharmacol"},{"issue":"7","key":"yrv260003r73","doi-asserted-by":"publisher","first-page":"2004","DOI":"10.1038\/s41591-024-03063-x","article-title":"Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial.","volume":"30","author":"Glue","year":"2024","journal-title":"Nat Med"},{"issue":"3","key":"yrv260003r74","doi-asserted-by":"publisher","first-page":"176","DOI":"10.1111\/bdi.12487","article-title":"Ketamine versus midazolam in bipolar depression with suicidal thoughts: a pilot midazolam-controlled randomized clinical trial.","volume":"19","author":"Grunebaum","year":"2017","journal-title":"Bipolar Disord"},{"issue":"4","key":"yrv260003r75","doi-asserted-by":"publisher","first-page":"327","DOI":"10.1176\/appi.ajp.2017.17060647","article-title":"Ketamine for rapid reduction of suicidal thoughts in major depression: a midazolam-controlled randomized clinical trial.","volume":"175","author":"Grunebaum","year":"2018","journal-title":"Am J Psychiatry"},{"issue":"3","key":"yrv260003r76","doi-asserted-by":"publisher","first-page":"623","DOI":"10.1017\/S0033291715002159","article-title":"Single iv ketamine augmentation of newly initiated escitalopram for major depression: results from a randomized, placebo-controlled 4-week study.","volume":"46","author":"Hu","year":"2016","journal-title":"Psychol Med"},{"key":"yrv260003r77","doi-asserted-by":"publisher","first-page":"516","DOI":"10.1016\/j.jad.2018.09.037","article-title":"Repeat-dose ketamine augmentation for treatment-resistant depression with chronic suicidal ideation: a randomized, double blind, placebo controlled trial.","volume":"243","author":"Ionescu","year":"2019","journal-title":"J Affect Disord"},{"issue":"1","key":"yrv260003r78","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1093\/ijnp\/pyaa068","article-title":"Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of a phase 3, double-blind, randomized study (ASPIRE II).","volume":"24","author":"Ionescu","year":"2021","journal-title":"Int J Neuropsychopharmacol"},{"key":"yrv260003r79","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaac.2025.02.015","article-title":"Effect of esketamine on depressive symptoms in adolescents with major depressive disorder at imminent suicide risk: a randomized psychoactive-controlled study.","author":"Kosik-Gonzalez","journal-title":"J Am Acad Child Adolesc Psychiatry"},{"issue":"7","key":"yrv260003r80","doi-asserted-by":"publisher","first-page":"579","DOI":"10.3109\/15622975.2014.922697","article-title":"Pilot dose-response trial of iv ketamine in treatment-resistant depression.","volume":"15","author":"Lai","year":"2014","journal-title":"World J Biol Psychiatry"},{"issue":"3","key":"yrv260003r81","doi-asserted-by":"publisher","DOI":"10.1136\/gpsych-2023-101007","article-title":"Efficacy of repeated intravenous esketamine in adolescents with anxious versus non-anxious depression.","volume":"36","author":"Lan","year":"2023","journal-title":"Gen Psychiatr"},{"issue":"12","key":"yrv260003r82","doi-asserted-by":"publisher","first-page":"970","DOI":"10.1016\/j.biopsych.2014.03.026","article-title":"A randomized controlled trial of intranasal ketamine in major depressive disorder.","volume":"76","author":"Lapidus","year":"2014","journal-title":"Biol Psychiatry"},{"key":"yrv260003r83","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1016\/j.jad.2023.02.151","article-title":"Arketamine as adjunctive therapy for treatment-resistant depression: a placebo-controlled pilot study.","volume":"330","author":"Leal","year":"2023","journal-title":"J Affect Disord"},{"issue":"3","key":"yrv260003r84","doi-asserted-by":"publisher","first-page":"1080","DOI":"10.1002\/hbm.23085","article-title":"The effects of low-dose ketamine on the prefrontal cortex and amygdala in treatment-resistant depression: a randomized controlled study.","volume":"37","author":"Li","year":"2016","journal-title":"Hum Brain Mapp"},{"issue":"11","key":"yrv260003r85","doi-asserted-by":"publisher","first-page":"876","DOI":"10.1038\/s44220-023-00140-x","article-title":"Randomized trial of ketamine masked by surgical anesthesia in patients with depression.","volume":"1","author":"Lii","year":"2023","journal-title":"Nat Ment Health"},{"issue":"5","key":"yrv260003r86","doi-asserted-by":"publisher","first-page":"1088","DOI":"10.1038\/s41386-021-01242-9","article-title":"Identification of an optimal dose of intravenous ketamine for late-life treatment-resistant depression: a Bayesian adaptive randomization trial.","volume":"47","author":"Lijffijt","year":"2022","journal-title":"Neuropsychopharmacology"},{"issue":"6","key":"yrv260003r87","doi-asserted-by":"publisher","first-page":"533","DOI":"10.1192\/bjp.2023.79","article-title":"Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial.","volume":"223","author":"Loo","year":"2023","journal-title":"Br J Psychiatry"},{"issue":"8","key":"yrv260003r88","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.13211","article-title":"Assessment of relationship of ketamine dose with magnetic resonance spectroscopy of Glx and GABA responses in adults with major depression: a randomized clinical trial.","volume":"3","author":"Milak","year":"2020","journal-title":"JAMA Netw Open"},{"issue":"10","key":"yrv260003r89","doi-asserted-by":"publisher","first-page":"1134","DOI":"10.1176\/appi.ajp.2013.13030392","article-title":"Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial.","volume":"170","author":"Murrough","year":"2013","journal-title":"Am J Psychiatry"},{"issue":"1","key":"yrv260003r90","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1186\/s40345-023-00308-5","article-title":"NRX-101 (D-cycloserine plus lurasidone) vs. lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior: a randomized prospective phase 2 trial.","volume":"11","author":"Nierenberg","year":"2023","journal-title":"Int J Bipolar Disord"},{"issue":"7","key":"yrv260003r91","doi-asserted-by":"publisher","first-page":"1040","DOI":"10.1038\/s41380-018-0028-2","article-title":"Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects.","volume":"24","author":"Nugent","year":"2019","journal-title":"Mol Psychiatry"},{"issue":"2","key":"yrv260003r92","doi-asserted-by":"publisher","first-page":"121","DOI":"10.1016\/j.jagp.2019.10.008","article-title":"Efficacy and safety of esketamine nasal spray plus an oral antidepressant in elderly patients with treatment-resistant depression-TRANSFORM-3.","volume":"28","author":"Ochs-Ross","year":"2020","journal-title":"Am J Geriatr Psychiatry"},{"issue":"5","key":"yrv260003r94","doi-asserted-by":"publisher","first-page":"483","DOI":"10.4103\/indianjpsychiatry.indianjpsychiatry_80_21","article-title":"Antisuicidal efficacy of ketamine infusion in suicidal patients of depressive disorder.","volume":"63","author":"Pathak","year":"2021","journal-title":"Indian J Psychiatry"},{"issue":"1","key":"yrv260003r95","doi-asserted-by":"publisher","first-page":"512","DOI":"10.1186\/s12888-024-05951-5","article-title":"A randomized controlled pilot study of daily intravenous ketamine over three days for treatment-resistant depression.","volume":"24","author":"Pattanaseri","year":"2024","journal-title":"BMC Psychiatry"},{"issue":"5","key":"yrv260003r96","doi-asserted-by":"publisher","first-page":"401","DOI":"10.1176\/appi.ajp.2018.18070834","article-title":"Single, repeated, and maintenance ketamine infusions for treatment-resistant depression: a randomized controlled trial.","volume":"176","author":"Phillips","year":"2019","journal-title":"Am J Psychiatry"},{"issue":"6","key":"yrv260003r97","doi-asserted-by":"publisher","first-page":"428","DOI":"10.1176\/appi.ajp.2019.19020172","article-title":"Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: a randomized double-blind active-controlled study.","volume":"176","author":"Popova","year":"2019","journal-title":"Am J Psychiatry"},{"issue":"12","key":"yrv260003r98","doi-asserted-by":"publisher","first-page":"959","DOI":"10.1176\/appi.ajp.20220216","article-title":"A Novel, brief, fully automated intervention to extend the antidepressant effect of a single ketamine infusion: a randomized clinical trial.","volume":"179","author":"Price","year":"2022","journal-title":"Am J Psychiatry"},{"issue":"1","key":"yrv260003r99","doi-asserted-by":"publisher","first-page":"206","DOI":"10.1038\/s41398-020-00897-0","article-title":"A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression.","volume":"10","author":"Shiroma","year":"2020","journal-title":"Transl Psychiatry"},{"issue":"6","key":"yrv260003r100","doi-asserted-by":"publisher","first-page":"424","DOI":"10.1016\/j.biopsych.2015.10.018","article-title":"Intravenous esketamine in adult treatment-resistant depression: a double-blind, double-randomization, placebo-controlled study.","volume":"80","author":"Singh","year":"2016","journal-title":"Biol Psychiatry"},{"issue":"8","key":"yrv260003r101","doi-asserted-by":"publisher","first-page":"816","DOI":"10.1176\/appi.ajp.2016.16010037","article-title":"A double-blind, randomized, placebo-controlled, dose-frequency study of intravenous ketamine in patients with treatment-resistant depression.","volume":"173","author":"Singh","year":"2016","journal-title":"Am J Psychiatry"},{"key":"yrv260003r102","article-title":"Relationship of ketamine\u2019s antidepressant and psychotomimetic effects in unipolar depression.","author":"Sos","journal-title":"Neuro Endocrinol Lett"},{"issue":"13","key":"yrv260003r103","doi-asserted-by":"publisher","first-page":"2482","DOI":"10.1038\/npp.2017.94","article-title":"Dose-related effects of adjunctive ketamine in Taiwanese patients with treatment-resistant depression.","volume":"42","author":"Su","year":"2017","journal-title":"Neuropsychopharmacology"},{"issue":"5","key":"yrv260003r104","doi-asserted-by":"publisher","first-page":"331","DOI":"10.1093\/ijnp\/pyad014","article-title":"A randomized, double-blind, midazolam-controlled trial of low-dose ketamine infusion in patients with treatment-resistant depression and prominent suicidal ideation.","volume":"26","author":"Su","year":"2023","journal-title":"Int J Neuropsychopharmacol"},{"issue":"1","key":"yrv260003r105","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.bpsc.2019.07.002","article-title":"Ketamine enhances visual sensory evoked potential long-term potentiation in patients with major depressive disorder.","volume":"5","author":"Sumner","year":"2020","journal-title":"Biol Psychiatry Cogn Neurosci Neuroimaging"},{"issue":"1","key":"yrv260003r106","doi-asserted-by":"publisher","first-page":"526","DOI":"10.1186\/s12888-021-03538-y","article-title":"Efficacy and safety of fixed doses of intranasal esketamine as an add-on therapy to oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study.","volume":"21","author":"Takahashi","year":"2021","journal-title":"BMC Psychiatry"},{"key":"yrv260003r107","doi-asserted-by":"publisher","DOI":"10.1093\/ijnp\/pyaf056","article-title":"Antidepressant efficacy of ketamine plus naltrexone for major depression comorbid with alcohol use disorder: a randomized controlled trial.","author":"Yoon","journal-title":"International Journal of Neuropsychopharmacology"},{"issue":"4","key":"yrv260003r108","doi-asserted-by":"publisher","first-page":"396","DOI":"10.18502\/ijps.v18i4.13627","article-title":"A comparison between single and double-dose intravenous ketamine administration in bipolar mood disorder: a double-blind controlled clinical trial.","volume":"18","author":"Talaei","year":"2023","journal-title":"Iran J Psychiatry"},{"issue":"1","key":"yrv260003r109","doi-asserted-by":"publisher","first-page":"159","DOI":"10.1038\/s41398-020-0844-4","article-title":"A randomized placebo-controlled PET study of ketamine\u00b4s effect on serotonin1B receptor binding in patients with SSRI-resistant depression.","volume":"10","author":"Tiger","year":"2020","journal-title":"Transl Psychiatry"},{"issue":"8","key":"yrv260003r110","doi-asserted-by":"publisher","first-page":"856","DOI":"10.1001\/archpsyc.63.8.856","article-title":"A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression.","volume":"63","author":"Zarate","year":"2006","journal-title":"Arch Gen Psychiatry"},{"issue":"11","key":"yrv260003r111","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1016\/j.biopsych.2011.12.010","article-title":"Replication of ketamine\u2019s antidepressant efficacy in bipolar depression: a randomized controlled add-on trial.","volume":"71","author":"Zarate","year":"2012","journal-title":"Biol Psychiatry"},{"issue":"5","key":"yrv260003r112","doi-asserted-by":"publisher","first-page":"507","DOI":"10.1016\/j.jaac.2023.05.031","article-title":"Effect of repeated intravenous esketamine on adolescents with major depressive disorder and suicidal ideation: a randomized active-placebo-controlled trial.","volume":"63","author":"Zhou","year":"2024","journal-title":"J Am Acad Child Adolesc Psychiatry"},{"issue":"1","key":"yrv260003r113","doi-asserted-by":"publisher","first-page":"341","DOI":"10.1186\/s12888-024-05716-0","article-title":"Rapid and sustained antidepressant effects of intravenous ketamine in treatment-resistant major depressive disorder and suicidal ideation: a randomized clinical trial.","volume":"24","author":"Zolghadriha","year":"2024","journal-title":"BMC Psychiatry"},{"issue":"9","key":"yrv260003r114","doi-asserted-by":"publisher","first-page":"877","DOI":"10.1001\/jamapsychiatry.2025.1317","article-title":"Esketamine monotherapy in adults with treatment-resistant depression: a randomized clinical trial.","volume":"82","author":"Janik","year":"2025","journal-title":"JAMA Psychiatry"},{"issue":"11","key":"yrv260003r115","doi-asserted-by":"publisher","first-page":"907","DOI":"10.1016\/S2215-0366(22)00317-0","article-title":"Maintenance ketamine treatment for depression: a systematic review of efficacy, safety, and tolerability.","volume":"9","author":"Smith-Apeldoorn","year":"2022","journal-title":"Lancet Psychiatry"},{"key":"yrv260003r116","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajp.2025.104413","article-title":"Oral ketamine for rapid reduction of suicidal ideation in major depressive disorder: a midazolam-controlled randomized clinical trial.","volume":"106","author":"Seraj","year":"2025","journal-title":"Asian J Psychiatr"},{"key":"yrv260003r117","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.23m14974","article-title":"A randomized, double-blind, placebo-controlled pilot trial of the acute antisuicidal and antidepressant effects of intranasal (r,s)-ketamine in severe unipolar and bipolar depression with and without comorbid alcohol use disorder.","author":"Jones","year":"2024","journal-title":"J Clin Psychiatry"},{"issue":"8","key":"yrv260003r118","doi-asserted-by":"publisher","DOI":"10.1093\/ijnp\/pyaf056","article-title":"Antidepressant efficacy of ketamine plus naltrexone for major depression comorbid with alcohol use disorder: a randomized controlled trial.","volume":"28","author":"Yoon","year":"2025","journal-title":"Int J Neuropsychopharmacol"},{"issue":"6","key":"yrv260003r119","doi-asserted-by":"publisher","first-page":"533","DOI":"10.1192\/bjp.2023.79","article-title":"Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial.","volume":"223","author":"Loo","year":"2023","journal-title":"Br J Psychiatry"},{"issue":"11","key":"yrv260003r120","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1016\/j.biopsych.2011.12.010","article-title":"Replication of ketamine\u2019s antidepressant efficacy in bipolar depression: a randomized controlled add-on trial.","volume":"71","author":"Zarate","year":"2012","journal-title":"Biol Psychiatry"},{"issue":"3","key":"yrv260003r121","doi-asserted-by":"publisher","DOI":"10.1136\/gpsych-2023-101007","article-title":"Efficacy of repeated intravenous esketamine in adolescents with anxious versus non-anxious depression.","volume":"36","author":"Lan","year":"2023","journal-title":"Gen Psychiatr"},{"issue":"7","key":"yrv260003r122","doi-asserted-by":"publisher","first-page":"2004","DOI":"10.1038\/s41591-024-03063-x","article-title":"Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial.","volume":"30","author":"Glue","year":"2024","journal-title":"Nat Med"},{"issue":"12","key":"yrv260003r123","doi-asserted-by":"publisher","first-page":"1295","DOI":"10.1177\/0269881118806297","article-title":"3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: a randomized phase 2 controlled trial.","volume":"32","author":"Ot\u2019alora G","year":"2018","journal-title":"J Psychopharmacol"},{"issue":"1","key":"yrv260003r124","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1177\/0269881112464827","article-title":"A randomized, controlled pilot study of MDMA (\u00b1 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic post-traumatic stress disorder (PTSD).","volume":"27","author":"Oehen","year":"2013","journal-title":"J Psychopharmacol"},{"issue":"6","key":"yrv260003r125","doi-asserted-by":"publisher","first-page":"1025","DOI":"10.1038\/s41591-021-01336-3","article-title":"MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.","volume":"27","author":"Mitchell","year":"2021","journal-title":"Nat Med"},{"issue":"4","key":"yrv260003r126","doi-asserted-by":"publisher","first-page":"439","DOI":"10.1177\/0269881110378371","article-title":"The safety and efficacy of +\/-3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.","volume":"25","author":"Mithoefer","year":"2011","journal-title":"J Psychopharmacol"},{"issue":"6","key":"yrv260003r127","doi-asserted-by":"publisher","first-page":"486","DOI":"10.1016\/S2215-0366(18)30135-4","article-title":"3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial.","volume":"5","author":"Mithoefer","year":"2018","journal-title":"Lancet Psychiatry"},{"issue":"1","key":"yrv260003r128","doi-asserted-by":"publisher","first-page":"20442","DOI":"10.1038\/s41598-020-75706-1","article-title":"MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study.","volume":"10","author":"Wolfson","year":"2020","journal-title":"Sci Rep"},{"issue":"3","key":"yrv260003r129","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1080\/02791072.2008.10400637","article-title":"MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder.","volume":"40","author":"Bouso","year":"2008","journal-title":"J Psychoactive Drugs"},{"issue":"1","key":"yrv260003r132","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0295926","article-title":"Effects of MDMA-assisted therapy for PTSD on self-experience.","volume":"19","author":"van der Kolk","year":"2024","journal-title":"PLoS One"},{"issue":"5","key":"yrv260003r133","doi-asserted-by":"publisher","first-page":"540","DOI":"10.1097\/JCP.0000000000001428","article-title":"Ayahuasca improves self-perception of speech performance in subjects with social anxiety disorder: a pilot, proof-of-concept, randomized, placebo-controlled trial.","volume":"41","author":"Dos Santos","year":"2021","journal-title":"J Clin Psychopharmacol"},{"issue":"4","key":"yrv260003r134","doi-asserted-by":"publisher","first-page":"655","DOI":"10.1017\/S0033291718001356","article-title":"Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial.","volume":"49","author":"Palhano-Fontes","year":"2019","journal-title":"Psychol Med"},{"key":"yrv260003r135","doi-asserted-by":"publisher","DOI":"10.1007\/BF00367455","article-title":"Comparison of altered states of consciousness induced by the hallucinogens (-)-?9-trans-tetrahydrocannabinol (?9-THC) and N, N-dimethyltryptamine (DMT).","author":"Dittrich","year":"1976","journal-title":"Arch Fur Psychiatr Nervenkrankh"},{"issue":"1","key":"yrv260003r136","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1007\/BF00429362","article-title":"Comparison of a placebo, N-dimethyltryptamine, and 6-hydroxy-N-dimethyltryptamine in man.","volume":"4","author":"Rosenberg","year":"1963","journal-title":"Psychopharmacologia"},{"issue":"6","key":"yrv260003r137","doi-asserted-by":"publisher","first-page":"460","DOI":"10.1002\/cpdd.254","article-title":"Ascending single-dose, double-blind, placebo-controlled safety study of noribogaine in opioid-dependent patients.","volume":"5","author":"Glue","year":"2016","journal-title":"Clin Pharmacol Drug Dev"},{"issue":"5","key":"yrv260003r138","doi-asserted-by":"publisher","first-page":"531","DOI":"10.1001\/jamapsychiatry.2025.0085","article-title":"Expectancy effects, failure of blinding integrity, and placebo response in trials of treatments for psychiatric disorders: a narrative review.","volume":"82","author":"Huneke","year":"2025","journal-title":"JAMA Psychiatry"},{"key":"yrv260003r139","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-078607","article-title":"Comparative oral monotherapy of psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine, ayahuasca, and escitalopram for depressive symptoms: systematic review and Bayesian network meta-analysis.","volume":"386","author":"Hsu","year":"2024","journal-title":"BMJ"},{"issue":"7","key":"yrv260003r140","doi-asserted-by":"publisher","first-page":"1233","DOI":"10.1038\/s41386-019-0317-8","article-title":"Impact of midazolam vs. saline on effect size estimates in controlled trials of ketamine as a rapid-acting antidepressant.","volume":"44","author":"Wilkinson","year":"2019","journal-title":"Neuropsychopharmacology"},{"issue":"10","key":"yrv260003r141","doi-asserted-by":"publisher","first-page":"913","DOI":"10.1176\/appi.ajp.20240655","article-title":"Real-world safety of esketamine nasal spray: a comprehensive analysis almost 5 years after first approval.","volume":"182","author":"Sanacora","year":"2025","journal-title":"Am J Psychiatry"},{"issue":"2","key":"yrv260003r143","doi-asserted-by":"publisher","first-page":"143","DOI":"10.1016\/j.cct.2003.10.016","article-title":"Assessment of blinding in clinical trials.","volume":"25","author":"Bang","year":"2004","journal-title":"Control Clin Trials"},{"issue":"2","key":"yrv260003r144","doi-asserted-by":"publisher","first-page":"42","DOI":"10.3109\/10601331003777444","article-title":"Blinding assessment in clinical trials: a review of statistical methods and a proposal of blinding assessment protocol.","volume":"27","author":"Bang","year":"2010","journal-title":"Clin Res Regul Aff"},{"issue":"6","key":"yrv260003r145","doi-asserted-by":"publisher","first-page":"767","DOI":"10.1177\/1740774512465064","article-title":"Development of the Stanford Expectations of Treatment Scale (SETS): a tool for measuring patient outcome expectancy in clinical trials.","volume":"9","author":"Younger","year":"2012","journal-title":"Clin Trials"},{"issue":"8","key":"yrv260003r146","doi-asserted-by":"publisher","first-page":"1717","DOI":"10.1017\/S0033291723003653","article-title":"Assessing expectancy and suggestibility in a trial of escitalopram v. psilocybin for depression.","volume":"54","author":"Szigeti","year":"2024","journal-title":"Psychol Med"},{"key":"yrv260003r148","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1016\/j.euroneuro.2022.05.002","article-title":"Expert consensus recommendations on the use of randomized clinical trials for drug approval in psychiatry\u2014comparing trial designs.","volume":"60","author":"Similon","year":"2022","journal-title":"Eur Neuropsychopharmacol"},{"issue":"6","key":"yrv260003r149","doi-asserted-by":"publisher","first-page":"1989","DOI":"10.1007\/s00213-022-06123-7","article-title":"Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials.","volume":"239","author":"Aday","year":"2022","journal-title":"Psychopharmacology (Berl)"},{"key":"yrv260003r150","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.2025.51","article-title":"Rethinking placebo-controlled clinical trials in psychedelic therapies for psychiatric illness.","author":"Lehrner","journal-title":"Br J Psychiatry"},{"issue":"2","key":"yrv260003r151","doi-asserted-by":"publisher","first-page":"193","DOI":"10.4103\/idoj.IDOJ_475_18","article-title":"Clinical trial designs.","volume":"10","author":"Nair","year":"2019","journal-title":"Indian Dermatol Online J"},{"issue":"10","key":"yrv260003r152","doi-asserted-by":"publisher","first-page":"1317","DOI":"10.1080\/17512433.2021.1951473","article-title":"Who is blind in psychedelic research? Letter to the editor regarding: blinding and expectancy confounds in psychedelic randomized controlled trials.","volume":"14","author":"Schenberg","year":"2021","journal-title":"Expert Rev Clin Pharmacol"},{"issue":"3","key":"yrv260003r153","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1001\/jamapsychiatry.2024.4312","article-title":"Modifying informed consent to help address functional unmasking in psychedelic clinical trials.","volume":"82","author":"Matvey","year":"2025","journal-title":"JAMA Psychiatry"},{"issue":"1","key":"yrv260003r154","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1176\/appi.ajp.20230902","article-title":"Psychedelics for the treatment of psychiatric disorders: interpreting and translating available evidence and guidance for future research.","volume":"182","author":"McIntyre","year":"2025","journal-title":"Am J Psychiatry"},{"key":"yrv260003r16","unstructured":"Covidence. Covidence\u2014better systematic review management. Accessed March 10, 2026. https:\/\/www.covidence.org\/"},{"key":"yrv260003r67","unstructured":"Gallagher? B. Ketamine as an adjunctive therapy for major depression\u2014a randomised controlled pragmatic pilot trial (Karma-Dep Trial). Published online Accessed March 10, 2026. doi:10.5281\/ZENODO.4302297"},{"key":"yrv260003r93","doi-asserted-by":"crossref","unstructured":"Ohtani? Y, Tani? H, Nomoto-Takahashi? K, . Efficacy and safety of intravenous ketamine treatment in Japanese patients with treatment-resistant depression: a double-blind, randomized, placebo-controlled trial.? Psychiatry and Clinical Neurosciences. Published online August 20, 2024. https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pcn.13734","DOI":"10.1111\/pcn.13734"},{"key":"yrv260003r130","unstructured":"Lykos Therapeutics. A randomized, double-blind, active placebo-controlled phase 2 pilot study of MDMA-assisted psychotherapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). Accessed March 10, 2026. https:\/\/clinicaltrials.gov\/study\/NCT01689740"},{"key":"yrv260003r131","unstructured":"Lykos Therapeutics. A randomized, double-blind, controlled phase 2 pilot study of manualized 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in 12 subjects with treatment-resistant posttraumatic stress disorder (PTSD). Accessed March 10, 2026. https:\/\/clinicaltrials.gov\/study\/NCT01958593"},{"key":"yrv260003r142","unstructured":"US Food and Drug Administration. Psychedelic drugs: considerations for clinical investigations. Accessed March 10, 2026. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/psychedelic-drugs-considerations-clinical-investigations"},{"key":"yrv260003r147","unstructured":"Centre for Addiction and Mental Health. Does psilocybin require psychedelic effects to treat depression? a 4-week, double-blind, proof-of-concept randomized controlled trial. Accessed March 10, 2026. https:\/\/clinicaltrials.gov\/study\/NCT05710237"}],"container-title":["JAMA Psychiatry"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamapsychiatry\/articlepdf\/2847667\/jamapsychiatry_orsini_2026_rv_260003_1782743844.54081.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T15:08:50Z","timestamp":1782918530000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamapsychiatry\/fullarticle\/2847667"}},"subtitle":["A Systematic Review"],"short-title":[],"issued":{"date-parts":[[2026,7,1]]},"references-count":154,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamapsychiatry.2026.0255","relation":{},"ISSN":["2168-622X"],"issn-type":[{"value":"2168-622X","type":"print"}],"subject":[],"published":{"date-parts":[[2026,7,1]]}}}