[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100258163":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":47,"studyPopulation":35,"armGroups":48,"interventions":59,"overallOfficials":67,"centralContacts":71,"locations":82,"responsibleParty":106,"collaborators":35,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":35,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":35,"enrollmentInfo":118,"targetDuration":35,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":84,"whyStopped":35,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Centre for Addiction and Mental Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Brief Psychiatric Rating 18 item Scale (BPRS 18 item scale)","Change in BPRS total scores from baseline to 12 weeks\n\nTotal scores range from 18-126, higher scores represent worse clinical outcomes:\n\n\\\u003C31 = Illness not significant \\>=31 = Mildly ill \\>41 = Moderately ill \\>53 = Markedly ill.","0 and 12 weeks",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Glasgow Antipsychotic Side-effect Scale for Clozapine (GASS-C)","Detect side effects related to Clozapine from baseline to 12 weeks\n\nHigher Scores indicating worse side-effects:\n\n0-16 (absent\u002Fmild side-effects) 17-32 (moderate side-effects) 33-48 (severe side-effects)",{"measure":18,"description":19,"timeFrame":12},"Brief Evaluation of Psychosis Symptom Domains (BE-PSD)","Assess the overall severity of five symptom domains of BE-PSD with a total score in each domain scoring from absent to very severe (i.e. 0-6 with higher scores with worse outcomes)",{"measure":21,"description":22,"timeFrame":12},"Personal and Social Performance scale (PSP)","Change in patients social functioning scores from baseline to 12 weeks The PSP is a 100-point single item rating scale from 1-100, subdivided into 10 equal intervals with higher scores indicating better outcomes. The ratings are based on patient's functioning in four main areas: 1) socially useful activities, 2) personal and social relationships, 3) self-care; and 4) disturbing and aggressive behaviours.",{"measure":24,"description":25,"timeFrame":12},"Clinical Global Impression - Severity of Illness (CGI-S)","Assess severity of Illness in Schizophrenia CGI scores from baseline to 12 weeks Scores ranging from normal to the most ill (i.e., scores ranging from 1-7 with higher scores with illness worsening)",{"measure":27,"description":28,"timeFrame":12},"Brief Neurocognitive Assessment (BNA)","The BNA is a brief neurocognitive assessment that measures global cognitive impairment in patients with schizophrenia from baseline to 12 weeks. Negative Z scores (i.e., -0.5 to -2.0 ) indicate mild to severe cognitive impairment.",{"measure":30,"description":31,"timeFrame":12},"Subjective Well-being under Neuroleptics scale - Short form (SWNS)","Self report scale to measure well being. Study assess changes in subjective wellbeing in patients on a neuroleptic from baseline to Week 12. Higher total score indicating better outcomes",{"measure":33,"description":34,"timeFrame":12},"Change in the Visual Analogue Scale for Distress Associated with Symptoms (VAS-DAS) scores from baseline to 12 weeks","Assess changes in level of distress associated with symptoms from no distress to worst distress (i.e., 0-100)",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":42},"QUADRUPLE",[43,44,45,46],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. To date, however, several randomized controlled trials (RCTs) have shown that once-daily dosing of antipsychotics including perphenazine, risperidone, olanzapine, quetiapine, and asenapine is comparable to twice-daily dosing in terms of efficacy and tolerability, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life.\n\nThis issue applies to clozapine as well, in that it has a relatively short plasma half-life of 12-16 hours; of note, the product monographs recommends that clozapine be administered more than once daily if the dose exceeds 200 mg\u002Fday in Canada. Despite this, in clinical practice clozapine is frequently administered once daily because of convenience and side effects such as a daytime sedation or somnolence, In support of this, a cross-sectional survey done at the investigators' own centre has revealed that clozapine was prescribed once daily in 75.1% of 676 patients, even though \\>200 mg\u002Fday was administered in 88.6%. However, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Switch group","EXPERIMENTAL","Participants will receive clozapine once daily at evening or bedtime throughout the study period. If a participant takes ≥200 mg of clozapine at a time other than evening\u002Fbedtime, half of this dose will be switched to an evening\u002Fbedtime regimen on day 0 (baseline), then another half dose will be switched on day 7 (week 1). Participants will receive placebo in place of the clozapine dose that was switched to evening\u002Fbedtime.",[54],"Drug: Clozapine",{"label":56,"type":57,"description":58,"interventionNames":35},"Maintenance group","NO_INTERVENTION","Participants will continue to take clozapine twice daily throughout the study period.",[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Clozapine","Switching from twice-daily to once-daily clozapine dosing regimen",[50],[66],"Clozaril",[68],{"name":69,"affiliation":5,"role":70},"Gary Remington, MD, PhD","PRINCIPAL_INVESTIGATOR",[72,77],{"name":69,"role":73,"phone":74,"phoneExt":75,"email":76},"CONTACT","+1-416-535-8501","34750","Gary.Remington@camh.ca",{"name":78,"role":73,"phone":79,"phoneExt":80,"email":81},"Carol Borlido, BSc","416 535-8501","34321","carol.borlido@camh.ca",[83],{"facility":5,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"RECRUITING","Toronto","Ontario","M5T 1R8","Canada","CA",{"type":91,"coordinates":92},"Point",[93,94],-79.39864,43.70643,{"lat":94,"lon":93},[97,100,101,104],{"name":69,"role":73,"phone":98,"phoneExt":99,"email":76},"416-535-8501","34864",{"name":69,"role":70,"phone":35,"phoneExt":35,"email":35},{"name":102,"role":103,"phone":35,"phoneExt":35,"email":35},"Hiroyoshi Takeuchi, MD, PhD","SUB_INVESTIGATOR",{"name":105,"role":103,"phone":35,"phoneExt":35,"email":35},"Ofer Agid, MD",{"type":70,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Gary Remington","Professor","100258163","phase-4-switching-from-twice-daily-to-once-daily-clozapine-dosing-in-schizophrenia-100258163",false,"NCT02639702","Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia","Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia: A Pilot, Double-Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with schizophrenia or schizoaffective disorder based on DSM-IV criteria\n* Outpatient status\n* Ages 18 years or older\n* Has received clozapine twice a day, one of which is in the evening\u002Fbedtime, at the same dose and dosing regimen for at least 3 months\n* Fluent in English and competent to provide written informed consent\n\nExclusion Criteria:\n\n* Having significant medical or neurological illnesses\n* Pregnant or lactating","ALL","18 Years",{"count":119,"type":120},30,"ESTIMATED","INTERVENTIONAL",[123],"PHASE4","Plasma half-life has routinely been used to establish the dosing schedule of antipsychotics; for example, it is recommended that agents with a short plasma half-life be administered multiple times per day. However, to date, several randomized controlled trials (RCTs) have shown no differences in clinical outcomes between once- and twice-daily dosing of various antipsychotics, suggesting that once-daily dosing of antipsychotics is a viable option regardless of plasma half-life. This would apply to clozapine as well; however, there have been no studies comparing once-daily vs. twice-daily dosing regimens of clozapine in terms of efficacy and tolerability. To address this gap in the literature, the investigators shall conduct a pilot, double-blind, RCT to examine efficacy and tolerability following a switch to once-daily dosing regimen of clozapine in patients with schizophrenia receiving clozapine twice a day.",[126,127],"Schizophrenia","Schizoaffective Disorder",[62,129,130,131,126],"Dosing","Once daily","Regimen","2026-08-24",{"date":134,"type":135},"2026-08-25","ACTUAL",{"date":137,"type":135},"2016-10-15",{"date":139,"type":120},"2027-12-31",{"name":5,"class":6},1]