High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing oral doses of 1200 mg/d to 600 mg/d of quetiapine.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manhattan Psychiatric Center
• Collaborator: Nathan Kline Institute for Psychiatric Research
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

1. DSM-IV criteria for chronic schizophrenia or schizoaffective disorder

2. Sub-optimal treatment-response

3. Total score > 60 on the Positive and Negative Syndrome Scale (PANSS) at baseline of run-in phase and again at baseline of double blind phase

4. Age 18-64 years old

5. Signed informed consent

6. Patient is in good general medical health

Exclusion criteria:

1. History of failure to respond to 400 mg/day or more of clozapine for 8 contiguous weeks

2. History of failure to respond to quetiapine treatment at dosages > 1200 mg daily for 6 contiguous weeks

3. History of quetiapine intolerance (e.g., clinically significant leukopenia or agranulocytosis, or severe dystonic reactions)

4. Significant recent history of violence or suicidal activity, which required > 4 episodes of PRN anti-agitation medication per week

5. Mental retardation

6. Depot antipsychotic within 30 days before randomization

7. Significant medical illness requiring frequent dose adjustment or medication changes

Clozapine non-responders are explicitly excluded, as they would be unlikely to show a response in this study.