Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Olanzapine; Drug: Clozapine

• 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.

Study Timeline

• Study Start: 1998-08
• Primary Completion: 2002-06
• Study Completion: 2002-06
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

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