High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder
NCT ID: NCT00297947
Last Updated: 2015-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2004-12-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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600 mg/day quetiapine (Group B)
Patients qualifying for the Double Blind Phase will be randomly assigned to 600 mg quetiapine (Group B) daily and treated on the assigned dose in a double-blind fashion for 8 weeks
quetiapine
Participant will receive 600 mg/day of quetiapine for 8 weeks.
1200 mg/day quetiapine (Group A)
Patients qualifying for the Double Blind Phase will be randomly assigned to high dose 1200 mg quetiapine daily (Group A) on the assigned dose in a double-blind fashion for 8 weeks
quetiapine
Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
Interventions
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quetiapine
Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.
quetiapine
Participant will receive 600 mg/day of quetiapine for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
64 Years
ALL
No
Sponsors
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Nathan Kline Institute for Psychiatric Research
OTHER
Manhattan Psychiatric Center
OTHER
Responsible Party
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Jean-Pierre Lindenmayer
Clinical Director
Principal Investigators
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Jean-Pierre Lindenmayer, MD
Role: PRINCIPAL_INVESTIGATOR
Manhattan Psychiatric Center
Leslie Citrome, MD
Role: PRINCIPAL_INVESTIGATOR
Nathan Kline Institute for Psychiatric Research
Locations
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Manhattan Psychiatric Center
New York, New York, United States
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Countries
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References
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Citrome L, Jaffe A, Levine J, Lindenmayer JP. Dosing of quetiapine in schizophrenia: how clinical practice differs from registration studies. J Clin Psychiatry. 2005 Dec;66(12):1512-6. doi: 10.4088/jcp.v66n1203.
Lindenmayer JP, Citrome L, Khan A, Kaushik S, Kaushik S. A randomized, double-blind, parallel-group, fixed-dose, clinical trial of quetiapine at 600 versus 1200 mg/d for patients with treatment-resistant schizophrenia or schizoaffective disorder. J Clin Psychopharmacol. 2011 Apr;31(2):160-8. doi: 10.1097/JCP.0b013e31820f4fe0.
Related Links
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Quetiapine on Wikipedia
NIMH on Schizophrenia
Wikipedia on Schizophrenia
Other Identifiers
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IRUSQUET0348
Identifier Type: -
Identifier Source: org_study_id
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