High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder
Completed · Phase 2/Phase 3
Conditions studied: Schizophrenia, Schizoaffective Disorder
In brief
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.
Key facts
- Study ID
- NCT00297947
- Run by
- Manhattan Psychiatric Center
- People needed
- 60
- Starts
- 2004-12-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2015-04-17
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DSM-IV criteria for chronic schizophrenia or schizoaffective disorder
- Sub-optimal treatment-response
- 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
- Age 18-64 years old
- Signed informed consent
- Patient is in good general medical health
You may not qualify if…
- History of failure to respond to 400 mg/day or more of clozapine for 8 contiguous weeks
- History of failure to respond to quetiapine treatment at dosages > 1200 mg daily for 6 contiguous weeks
- History of quetiapine intolerance (e.g., clinically significant leukopenia or agranulocytosis, or severe dystonic reactions)
- Significant recent history of violence or suicidal activity, which required > 4 episodes of PRN anti-agitation medication per week
- Mental retardation
- Depot antipsychotic within 30 days before randomization
- 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.
Where it is running
- Manhattan Psychiatric Center — New York, New York, United States
- Nathan Kline Institute for Psychiatric Research — Orangeburg, New York, United States
Full record on ClinicalTrials.gov
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