Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia
- Registration Number
- NCT00169065
- Lead Sponsor
- Harvard Medical School (HMS and HSDM)
- 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 whether in a naturalistic setting olanzapine is a logical treatment choice (before using the more toxic clozapine) for some treatment refractory patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- 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 Criteria
- Current substance abuse;
- Suicide or homicide risk;
- Pregnancy or lactation;
- History of seizures or blood dyscrasias
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description olanzapine Olanzapine clozapine or olanzapine in treatment resistant schizophrenia Clozapine Clozapine Clozapine or olanzapine in treatment resistant schizophrenia
- Primary Outcome Measures
Name Time Method Changes in quality of life.
- Secondary Outcome Measures
Name Time Method Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.
Trial Locations
- Locations (1)
Commonwealth Research Center
🇺🇸Jamaica Plain, Massachusetts, United States