Status:
COMPLETED
High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Manhattan Psychiatric Center
Collaborating Sponsors:
Nathan Kline Institute for Psychiatric Research
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
The study will be conducted at two sites: Manhattan Psychiatric Center (MPC), and the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric Research/Rockland Psych...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00297947
Start Date
December 1 2004
End Date
October 1 2014
Last Update
April 17 2015
Active Locations (2)
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1
Manhattan Psychiatric Center
New York, New York, United States, 10035
2
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962