Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard Medical School; Harvard Medical School (HMS and HSDM)
• Collaborators: Commonwealth Research Center, Massachusetts; Dartmouth-Hitchcock Medical Center; Eli Lilly and Company; National Institute of Mental Health (NIMH)
• Treatments: Clozapine; Olanzapine

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