Schizophrenia Clinical Trial
Official title:
Switching Antipsychotics: Abrupt Discontinuation Versus Overlap
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | July 2004 |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Outpatients with a diagnosis of schizophrenia or schizoaffective disorder based on the Structured Clinical Interview for DSM-IV (SCID-I) - Candidacy for a trial of clozapine, defined as an inadequate clinical response to = two antipsychotics (detailed in a pivotal clozapine study) and/or intolerable side effects Exclusion Criteria: - Active substance use disorder; inability to undergo a trial of clozapine for medical reasons (e.g., myeloproliferative disorder or history of drug-induced granulocytopenia) - Evidence of significant nonadherence, defined as =75% adherence following patient interview, review of records, and discussion with treating physician and caregivers |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | The Ian Douglas Bebensee Foundation |
Canada,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Brief Psychiatric Rating Scale (BPRS) total scores from baseline to 8 weeks | 0 and 8 weeks | No | |
Secondary | Change in the Simpson-Angus Scale (SAS) total scores from baseline to 8 weeks | 0 and 8 weeks | Yes | |
Secondary | Change in the Barnes Akathisia Rating Scale (BARS) total scores from baseline to 8 weeks | 0 and 8 weeks | Yes | |
Secondary | Change in the Abnormal Involuntary Movement Scale (AIMS) overall severity scores from baseline to 8 weeks | 0 and 8 weeks | Yes | |
Secondary | Change in the UKU Side Effect Rating Scale (UKU) subscale average scores from baseline to 8 weeks | 0 and 8 weeks | Yes | |
Secondary | Change in the Clinical Global Impression - Severity scale (CGI-S) scores from baseline to 8 weeks | 0 and 8 weeks | No | |
Secondary | Change in the Calgary Depression Scale for Schizophrenia (CDSS) total scores from baseline to 8 weeks | 0 and 8 weeks | No | |
Secondary | Change in the Drug Attitude Inventory (DAI-10) total scores from baseline to 8 weeks | 0 and 8 weeks | No | |
Secondary | Change in the Schedule for the Assessment of Insight (SAI) total scores from baseline to 8 weeks | 0 and 8 weeks | No |
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