{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,11,8]],"date-time":"2024-11-08T00:40:08Z","timestamp":1731026408084,"version":"3.28.0"},"reference-count":29,"publisher":"Georg Thieme Verlag KG","issue":"06","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacopsychiatry"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n          Background Currently, guidance on the most effective treatment for\n                    patients with clozapine-resistant schizophrenia-spectrum disorders (SSD) is\n                    lacking. While augmentation strategies to clozapine with aripiprazole and\n                    electroconvulsive therapy (ECT) have been demonstrated to be effective in\n                    patients with clozapine-resistant schizophrenia spectrum disorders (CRS),\n                    head-to-head comparisons between these addition strategies are unavailable. We\n                    therefore aim to examine the feasibility of a larger randomized, single-blind\n                    trial comparing the effectiveness, cost-effectiveness, and safety of\n                    aripiprazole addition vs. ECT addition in CRS.<\/jats:p><jats:p>\n          Methods In this multi-center, randomized, single-blind feasibility study,\n                    the feasibility of recruiting 20 participants with CRS who will be randomized to\n                    either aripiprazole or bilateral ECT addition will be assessed. The main\n                    endpoint is the number of patients willing to be randomized. The number of\n                    screened individuals and reasons to decline participation will be recorded.\n                    Effects will be estimated for the benefit of the foreseen larger trial. To that\n                    end, differences between both arms in symptom severity will be assessed using\n                    blinded video assessments. In addition, tolerability (e.\u2009g., cognitive\n                    functioning), safety, quality of life, recovery, and all-cause discontinuation\n                    will be compared. The follow-up period is 16 weeks, after which non-responders\n                    will be given the option to switch to the other treatment.<\/jats:p><jats:p>\n          Discussion Strengths of this feasibility trial include maintaining\n                    blinding with video assessment, a possibility to switch groups in case of\n                    non-response, and a broad set of outcome measures. Identification of factors\n                    contributing to non-participation and drop-out will generate valuable\n                    information on trial feasibility and may enhance recruitment strategies in a\n                    follow-up RCT.<\/jats:p><jats:p>\n          Trial registration The study has been approved by the Medical Research\n                    Ethics Committee of the Amsterdam University Medical Center, location AMC, and\n                    was registered on 1 May 2022 in the EU Clinical Trials Register (EudraCT) under\n                    the trial name \u2018EMECLO\u2019 (2021\u2013006333\u201319).<\/jats:p>","DOI":"10.1055\/a-2364-4357","type":"journal-article","created":{"date-parts":[[2024,8,26]],"date-time":"2024-08-26T23:28:05Z","timestamp":1724714885000},"page":"290-295","source":"Crossref","is-referenced-by-count":0,"title":["Electroconvulsive Therapy Versus Aripiprazole Addition to Clozapine\n                    in Patients with Clozapine-Resistant Symptoms (EMECLO): A Protocol of a\n                    Single-Blind, Multicenter, Randomized-Controlled Feasibility\n                    Trial"],"prefix":"10.1055","volume":"57","author":[{"given":"Manouk","family":"den Toom","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam UMC, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Blanken","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam UMC, The Netherlands"},{"name":"Department of Psychiatry, Dijklander Ziekenhuis, Hoorn,\n                    Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Inge","family":"Horn","sequence":"additional","affiliation":[{"name":"MS centrum, Amsterdam UMC, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Selene","family":"Veerman","sequence":"additional","affiliation":[{"name":"Mental Health Service Noord Holland Noord, The\n                    Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joris J. B.","family":"van der Vlugt-Molenaar","sequence":"additional","affiliation":[{"name":"Antes \u2013 Parnassia Group, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariken B.","family":"de Koning","sequence":"additional","affiliation":[{"name":"Arkin Mental Health Care, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Bogers","sequence":"additional","affiliation":[{"name":"Mental Health Service Rivierduinen, High Care Clinics and Rivierduinen\n                    Academy, Leiden, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Enterman","sequence":"additional","affiliation":[{"name":"Parnassia, The Hague, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"de Jonge","sequence":"additional","affiliation":[{"name":"Pro Persona, Arnhem, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela","family":"Cianci","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, UMC Utrecht Brain Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerardus W. J.","family":"Frederix","sequence":"additional","affiliation":[{"name":"Mental Health Service Noord Holland Noord, The\n                    Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans J.","family":"de Haas","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam UMC, The Netherlands"},{"name":"Arkin Mental Health Care, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bram W.","family":"Storosum","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam UMC, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mike","family":"Veereschild","sequence":"additional","affiliation":[{"name":"GGNet Mental Health, Warnsveld, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Javadzadeh","sequence":"additional","affiliation":[{"name":"GGNet Mental Health, Warnsveld, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter F. J.","family":"Schulte","sequence":"additional","affiliation":[{"name":"Mental Health Service Noord Holland Noord, The\n                    Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Cohen","sequence":"additional","affiliation":[{"name":"Mental Health Service Noord Holland Noord, The\n                    Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jim","family":"van Os","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, UMC Utrecht Brain Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wiepke","family":"Cahn","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, UMC Utrecht Brain Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lieuwe","family":"de Haan","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam UMC, The Netherlands"},{"name":"Arkin Mental Health Care, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jasper B.","family":"Zantvoord","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam UMC, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jurjen J.","family":"Luykx","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Amsterdam UMC, The Netherlands"},{"name":"Department of Psychiatry and Neuropsychology, School for Mental Health\n                    and Neuroscience, Maastricht University Medical Center, Maastricht, The\n                    Netherlands"},{"name":"GGZ InGeest Mental Health Care, Amsterdam, The\n                    Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2024,8,26]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"1195","DOI":"10.1093\/schbul\/sby058","article-title":"Global epidemiology and burden of schizophrenia: Findings from the Global Burden\n                    of Disease Study 2016","volume":"44","author":"F J Charlson","year":"2018","journal-title":"Schizophr Bull"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1093\/schbul\/16.4.551","article-title":"At issue: Defining treatment refractoriness in schizophrenia","volume":"16","author":"H D Brenner","year":"1990","journal-title":"Schizophr Bull"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"898","DOI":"10.1016\/S0006-3223(01)01271-9","article-title":"Management of treatment resistance in schizophrenia","volume":"50","author":"R R Conley","year":"2001","journal-title":"Biol Psychiatry"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"166","DOI":"10.1176\/appi.ajp.2015.15030332","article-title":"Comparative effectiveness of clozapine and standard antipsychotic treatment in\n                    adults with schizophrenia","volume":"173","author":"T S Stroup","year":"2016","journal-title":"Am J Psychiatry"},{"key":"ref5","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1111\/acps.12954","article-title":"Clozapine as a first- or second-line treatment in schizophrenia: A systematic\n                    review and meta-analysis","volume":"138","author":"C Okhuijsen-Pfeifer","year":"2018","journal-title":"Acta Psychiatr Scand"},{"key":"ref6","doi-asserted-by":"crossref","first-page":"772","DOI":"10.1177\/0706743717718167","article-title":"Clozapine response rates among people with treatment-resistant schizophrenia:\n                    Data from a systematic review and meta-analysis","volume":"62","author":"D Siskind","year":"2017","journal-title":"Can J Psychiatry"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"628","DOI":"10.1097\/JCP.0000000000000579","article-title":"Bin et al. 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