Status:
COMPLETED
Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Conditions:
Schizophrenia
Eligibility:
All Genders
20-60 years
Phase:
PHASE4
Brief Summary
This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.
Detailed Description
This is a two-year open-label, randomized trial of the comparative effectiveness of clozapine versus olanzapine in patients with treatment refractory schizophrenia. The objective is to determine wheth...
Eligibility Criteria
Inclusion
- Age 20-60 years;
- 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
- Current substance abuse;
- Suicide or homicide risk;
- Pregnancy or lactation;
- History of seizures or blood dyscrasias
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00169065
Start Date
August 1 1998
End Date
June 1 2002
Last Update
April 7 2015
Active Locations (1)
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1
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130