Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia
NCT ID: NCT00169065
Last Updated: 2015-04-07
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
PHASE4
38 participants
INTERVENTIONAL
1998-08-31
2002-06-30
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
SINGLE
Study Groups
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Clozapine
Clozapine or olanzapine in treatment resistant schizophrenia
Clozapine
olanzapine
clozapine or olanzapine in treatment resistant schizophrenia
Olanzapine
Interventions
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Clozapine
Olanzapine
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of treatment refractory schizophrenia or schizoaffective disorder;
* BPRS score \> 21 (0-6) scale;
* Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a reasonable dose (i.e. risperidone 4-6 mg/day);
* The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
* Clinically appropriate for clozapine or olanzapine
Exclusion Criteria
* Suicide or homicide risk;
* Pregnancy or lactation;
* History of seizures or blood dyscrasias
20 Years
60 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Commonwealth Research Center, Massachusetts
OTHER
Eli Lilly and Company
INDUSTRY
Harvard Medical School (HMS and HSDM)
OTHER
Responsible Party
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AlanGreen
Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth
Principal Investigators
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Alan I Green, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Locations
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Commonwealth Research Center
Jamaica Plain, Massachusetts, United States
Countries
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Other Identifiers
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