Clozapine vs. Olanzapine: An Effectiveness Study
Overview
- Phase
- Phase 4
- Intervention
- Clozapine
- Conditions
- Schizophrenia
- Sponsor
- Harvard Medical School (HMS and HSDM)
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Changes in quality of life.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
AlanGreen
Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth
National Institute of Mental Health (NIMH)
Eligibility Criteria
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
Arms & Interventions
Clozapine
Clozapine or olanzapine in treatment resistant schizophrenia
Intervention: Clozapine
olanzapine
clozapine or olanzapine in treatment resistant schizophrenia
Intervention: Olanzapine
Outcomes
Primary Outcomes
Changes in quality of life.
Secondary Outcomes
- Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.