{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T15:25:32Z","timestamp":1783610732871,"version":"3.55.0"},"reference-count":34,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,2,24]],"date-time":"2023-02-24T00:00:00Z","timestamp":1677196800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Psychiatry"],"abstract":"<jats:p>Real-world evidence fills in an important gap by providing data on the effectiveness and tolerability of new medications in everyday patients. In this data collection form a Spanish hospital, the effectiveness and tolerability of cariprazine were evaluated in 14 patients who were admitted to the hospital due to an acute episode of schizophrenia or schizoaffective disorder. The collected data included demographic characteristics, history of disorder and previous treatment, and details of cariprazine therapy such as dosing, side effects and measurements of effectiveness <jats:italic>via<\/jats:italic> scales. Difference between admission and discharge on the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression-Severity (CGI-S) scale scores were evaluated using the Wilcoxon Signed-Rank test. Significant improvement was detected in nearly all patients (one patient dropped out) as measured by the BPRS Total, Negative symptom, Positive symptom, and Hostility scores. At admission, patients were markedly-moderately ill and at discharge the severity was reduced to borderline ill and normal according to the CGI-S. The CGI-Improvement scale also indicated very much and much improvement at discharge. Importantly, patients left the hospital with high doses of cariprazine, i.e., 7.5\u2009mg\/day or even 9.0\u2009mg\/day, but this did not cause safety problems; cariprazine well-tolerated as only a few patients experienced side effects such as akathisia. The results provide novel evidence regarding the tolerability and effectiveness of cariprazine in high doses patients on the schizophrenia spectrum.<\/jats:p>","DOI":"10.3389\/fpsyt.2023.1112697","type":"journal-article","created":{"date-parts":[[2023,2,24]],"date-time":"2023-02-24T04:51:16Z","timestamp":1677214276000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Successful high dose antipsychotic treatment with cariprazine in patients on the schizophrenia spectrum: Real-world evidence from a Spanish hospital setting"],"prefix":"10.3389","volume":"14","author":[{"given":"Lluis Niell","family":"Galmes","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elmars","family":"Rancans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,2,24]]},"reference":[{"key":"ref1","volume-title":"American Psychiatric Association: Diagnostic and statistical manual of mental disorders","year":"2013"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"664","DOI":"10.1016\/S2215-0366(18)30050-6","article-title":"Negative symptoms of schizophrenia: new developments and unanswered research questions","volume":"5","author":"Galderisi","year":"2018","journal-title":"Lancet Psychiatry"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"416","DOI":"10.1038\/496416a","article-title":"On the spectrum","volume":"496","author":"Adam","year":"2013","journal-title":"Nature"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"409","DOI":"10.1007\/s11920-013-0409-9","article-title":"Defining psychosis: the evolution of DSM-5 schizophrenia spectrum disorders","volume":"15","author":"Bhati","year":"2013","journal-title":"Curr Psychiatry Rep"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1017\/S0033291717001775","article-title":"The slow death of the concept of schizophrenia and the painful birth of the psychosis spectrum","volume":"48","author":"Guloksuz","year":"2018","journal-title":"Psychol Med"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"925","DOI":"10.1016\/j.neuint.2011.07.002","article-title":"Cariprazine (RGH-188), a potent D3\/D2 dopamine receptor partial agonist, binds to dopamine D3 receptors in vivo and shows antipsychotic-like and procognitive effects in rodents","volume":"59","author":"Gyerty\u00e1n","year":"2011","journal-title":"Neurochem Int"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1016\/j.euroneuro.2018.10.008","article-title":"Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: pooled analyses from 3 phase II\/III studies","volume":"29","author":"Marder","year":"2019","journal-title":"Eur Neuropsychopharmacol"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"e1574","DOI":"10.4088\/JCP.15m09997","article-title":"Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo-and active-controlled trial","volume":"76","author":"Durgam","year":"2015","journal-title":"J Clin Psychiatry"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1097\/YIC.0000000000000110","article-title":"Cariprazine in the treatment of schizophrenia: a proof-of-concept trial","volume":"31","author":"Durgam","year":"2016","journal-title":"Int Clin Psychopharmacol"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"450","DOI":"10.1016\/j.schres.2013.11.041","article-title":"An evaluation of the safety and efficacy of cariprazine in patients with acute exacerbation of schizophrenia: a phase II, randomized clinical trial","volume":"152","author":"Durgam","year":"2014","journal-title":"Schizophr Res"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1097\/JCP.0000000000000346","article-title":"Efficacy and safety of Cariprazine in acute exacerbation of schizophrenia: results from an international, phase III clinical trial","volume":"35","author":"Kane","year":"2015","journal-title":"J Clin Psychopharmacol"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"1103","DOI":"10.1016\/S0140-6736(17)30060-0","article-title":"Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial","volume":"389","author":"N\u00e9meth","year":"2017","journal-title":"Lancet"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"100","DOI":"10.1080\/08039480902786542","article-title":"Naturalistic studies\u2014researching the everyday clinical world","volume":"63","author":"Malm","year":"2009","journal-title":"Nord J Psychiatry"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"867","DOI":"10.1001\/jama.2018.10136","article-title":"Real-world evidence and real-world data for evaluating drug safety and effectiveness","volume":"320","author":"Corrigan-Curay","year":"2018","journal-title":"JAMA"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"2293","DOI":"10.1056\/NEJMsb1609216","article-title":"Real-world evidence \u2014 what is it and what can it tell us?","volume":"375","author":"Sherman","year":"2016","journal-title":"N Engl J Med"},{"key":"ref16","first-page":"4","article-title":"Strategies for dosing and switching antipsychotics for optimal clinical management","volume":"69","author":"Buckley","year":"2008","journal-title":"J Clin Psychiatry"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"140","DOI":"10.1177\/106286060301800402","article-title":"Clinical practice variations in prescribing antipsychotics for patients with schizophrenia","volume":"18","author":"Owen","year":"2003","journal-title":"Am J Med Qual"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"S19","DOI":"10.1007\/s10067-010-1636-7","article-title":"Observational studies: a valuable source for data on the true value of RA therapies","volume":"30","author":"Van Vollenhoven","year":"2011","journal-title":"Clin Rheumatol"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"799","DOI":"10.2466\/pr0.1962.10.3.799","article-title":"The brief psychiatric rating scale","volume":"10","author":"Overall","year":"1962","journal-title":"Psychol Rep"},{"key":"ref20","first-page":"28","article-title":"The clinical global impressions scale: applying a research tool in clinical practice","volume":"4","author":"Busner","year":"2007","journal-title":"Psychiatry"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/j.1600-0447.1987.tb10566.x","article-title":"The UKU side effect rating scale: a new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients","volume":"76","author":"Lingj\u00e6rde","year":"1987","journal-title":"Acta Psychiatr Scand"},{"key":"ref22","year":""},{"key":"ref23","doi-asserted-by":"publisher","first-page":"154","DOI":"10.1097\/YIC.0000000000000351","article-title":"The effectiveness and safety of cariprazine in schizophrenia patients with negative symptoms and insufficient effectiveness of previous antipsychotic therapy: an observational study","volume":"36","author":"Rancans","year":"2021","journal-title":"Int Clin Psychopharmacol"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"770234","DOI":"10.3389\/fpsyt.2021.770234","article-title":"Dosing cariprazine within and beyond clinical trials\u2014recommendations for the treatment of schizophrenia","volume":"12","author":"Rancans","year":"2021","journal-title":"Front Psychiatry"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"S105","DOI":"10.1192\/bjo.2021.312","article-title":"High dose antipsychotic therapy (HDAT) prescibing practice within the South Trafford community mental health team","volume":"7","author":"Sparasci","year":"2021","journal-title":"BJPsych Open"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"957","DOI":"10.2147\/NDT.S301225","article-title":"Safety and tolerability of cariprazine in patients with schizophrenia: a pooled analysis of eight phase ii\/iii studies","volume":"17","author":"Barab\u00e1ssy","year":"2021","journal-title":"Neuropsychiatr Dis Treat"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"327","DOI":"10.2147\/DDDT.S95100","article-title":"Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)","volume":"10","author":"Nakamura","year":"2016","journal-title":"Drug Des Devel Ther"},{"key":"ref28","doi-asserted-by":"publisher","first-page":"264","DOI":"10.1016\/j.schres.2016.06.030","article-title":"Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial","author":"Durgam","year":"2016","journal-title":"Schizophr Res"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"284","DOI":"10.4088\/JCP.14m09081","article-title":"Efficacy and safety of low-and high-dose Cariprazine in acute and mixed mania associated with bipolar i disorder: a double-blind, placebo-controlled study","volume":"76","author":"Calabrese","year":"2015","journal-title":"J Clin Psychiatry"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"372","DOI":"10.1111\/bdi.12852","article-title":"Efficacy and safety of cariprazine in bipolar I depression: a double-blind, placebo-controlled phase 3 study","volume":"22","author":"Earley","year":"2020","journal-title":"Bipolar Disord"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"439","DOI":"10.1176\/appi.ajp.2018.18070824","article-title":"Cariprazine treatment of bipolar depression: a randomized double-blind placebo-controlled phase 3 study","volume":"176","author":"Earley","year":"2019","journal-title":"Am J Psychiatr"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"296","DOI":"10.1016\/j.jad.2014.11.018","article-title":"Cariprazine in the treatment of acute mania in bipolar i disorder: a double-blind, placebo-controlled, Phase III trial","volume":"174","author":"Sachs","year":"2015","journal-title":"J Affect Disord"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"147","DOI":"10.1097\/YIC.0000000000000307","article-title":"Evaluation of cariprazine in the treatment of bipolar i and II depression: a randomized, double-blind, placebo-controlled, phase 2 trial","volume":"35","author":"Yatham","year":"2020","journal-title":"Int Clin Psychopharmacol"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"312","DOI":"10.1097\/YIC.0000000000000235","article-title":"Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial","volume":"33","author":"Fava","year":"2018","journal-title":"Int Clin Psychopharmacol"}],"container-title":["Frontiers in Psychiatry"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpsyt.2023.1112697\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,24]],"date-time":"2023-02-24T04:51:20Z","timestamp":1677214280000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpsyt.2023.1112697\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,24]]},"references-count":34,"alternative-id":["10.3389\/fpsyt.2023.1112697"],"URL":"https:\/\/doi.org\/10.3389\/fpsyt.2023.1112697","relation":{},"ISSN":["1664-0640"],"issn-type":[{"value":"1664-0640","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,24]]},"article-number":"1112697"}}