Switching Antipsychotics: Abrupt Discontinuation Versus Overlap

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Registration Number: NCT02640300

Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 33

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Brief Psychiatric Rating Scale (BPRS) total scores from baseline to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the Simpson-Angus Scale (SAS) total scores from baseline to 8 weeks;Change in the Barnes Akathisia Rating Scale (BARS) total scores from baseline to 8 weeks;Change in the Abnormal Involuntary Movement Scale (AIMS) overall severity scores from baseline to 8 weeks;Change in the UKU Side Effect Rating Scale (UKU) subscale average scores from baseline to 8 weeks;Change in the Clinical Global Impression - Severity scale (CGI-S) scores from baseline to 8 weeks;Change in the Calgary Depression Scale for Schizophrenia (CDSS) total scores from baseline to 8 weeks;Change in the Drug Attitude Inventory (DAI-10) total scores from baseline to 8 weeks;Change in the Schedule for the Assessment of Insight (SAI) total scores from baseline to 8 weeks