CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
Clozapinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02640300
NCT02640300Phase 4Completed

Switching Antipsychotics: Abrupt Discontinuation Versus Overlap

Centre for Addiction and Mental Health·interventional·Posted Dec 28, 2015·Updated Aug 21, 2024

In Brief

A Phase 4 clinical trial evaluating Clozapine for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Clozapine has been demonstrated to be clinically superior to other antipsychotics in treatment-resistant schizophrenia (TRS), and is positioned as such in treatment guidelines. Because it is relegated to use in TRS, guidelines require that it only be used after other antipsychotics have failed; accordingly, clinicians routinely contend with stopping the previous antipsychotic in making the switch to clozapine. Perhaps because of its numerous and potentially severe side effects, the issue of clozapine titration has frequently been addressed, although to our knowledge no study has, as of yet, assessed the comparability of gradual vs. immediate antipsychotic discontinuation in switching to clozapine. To address the gap in knowledge specific to clozapine, the investigators conducted a pilot, 8-week, double-blind, randomized controlled trial examining immediate vs. gradual antipsychotic discontinuation in patients with schizophrenia undergoing a switch to clozapine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 4CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2015
Enrollment StartMay 1, 1999
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.5 years ago

Interventions

Clozapinedrug

Switching to clozapine with immediate or gradual antipsychotic discontinuation