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Switching From Twice-Daily to Once-Daily Clozapine Dosing in Schizophrenia

StatusRecruiting
PhasePhase 4
Started2016-10-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Dec 2026 → Sep 30, 2027
See other at-risk trials from Centre for Addiction and Mental Health

Amendment history

2026-08-24
Study Status v11
Primary completion pushed: 2026-12 → 2027-09-30
Completion pushed: 2026-12 → 2027-12-31
Start date2016-08→2016-10-15
2023-09-03
Study Status, Outcome Measures v10
Secondary endpoints7 entries, revised
Change in the Glasgow Antipsychotic Side-effect Scale for Clozapine (GASS-C) total scores from baseline to 12 weeks Change in the Brief Evaluation of Psychosis Symptom Domains (BE-PSD) total scores from baseline to 12 weeks Change in the Personal and Social Performance scale (PSP) scores from baseline to 12 weeks Change in the Clinical Global Impression - Severity of Illness (CGI-S) scores from baseline and 12 weeks Change in the Brief Neurocognitive Assessment (BNA) Z scores from baseline to 12 weeks Change in the Subjective Well-being under Neuroleptics scale - Short form (SWNS) total scores [...]
Primary endpoints1 entry, revised
Change in the Brief Psychiatric Rating 18 item Scale (BPRS 18 item scale) total scores from baseline to 12 weeks
2023-08-31
Study Status, Outcome Measures, Contacts/Locations v9
Primary completion date2022-12→2026-12
Completion date2022-12→2026-12
Secondary endpointsdetails revised at 7 of 7 entries
2022-03-11
Study Status v8
Primary completion date2021-08→2022-12
2021-07-26
Study Status v7
Primary completion date2021-03→2021-08
Completion date2021-08→2022-12
Show 6 earlier versions
2020-07-16
Study Status v6
Re-verified, no change to tracked fields
2019-05-09
Study Status v5
Primary completion date2019-03→2021-03
Completion date2019-06→2021-08
2017-10-25
Study Status v4
Re-verified, no change to tracked fields
2016-08-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2016-08-09
Study Status, Arms and Interventions, Eligibility v2
Eligibility criteria-124 characters
[...] disorder based on DSM-IV criteria Outpatient status Ages 18 toyears 55or yearsolder Has received clozapine twice a day, one of which is in the [...] teria: Having significant medical or neurological illnesses Diagnosed with substance-related disorders based on DSM-IV criteria Diagnosed with mental retardation based on DSM-IV criteria Pregnant or lactating
2016-06-30
Study Status, Outcome Measures, References v1
Start date2016-04→2016-08
Secondary endpoints7 entries, revised
Change in the ClinicalBrief GlobalEvaluation Impression -of Psychosis Symptom Domains (CGIBE-PPSD) total scores from baseline to 12 weeks Change in the Visual Analogue Scale (VAS) for Distress Associated with Symptoms (VAS-DAS) scores from baseline to 12 weeks
Publications7 to 8 entries
Takeuchi H, Powell V, Geisler S, DeSanti M, Fervaha G, Agid O, Kane JM, Remington G. Clozapine administration in clinical practice: once-daily versus divided dosing. Acta Psychiatr Scand. 2016 Sep;134(3):234-40. doi: 10.1111/acps.12593. Epub 2016 May 16.
2015-12-22
Original filing
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.
Trial Details
NCT Number NCT02639702
Lead Sponsor Centre for Addiction and Mental Health
Conditions Schizophrenia, Schizoaffective Disorder
Enrollment 30 participants
Start Date 2016-10-15
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-25