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Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

Information source: Harvard Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Clozapine (Drug); Olanzapine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Harvard Medical School

Official(s) and/or principal investigator(s):
Alan I Green, MD, Principal Investigator, Affiliation: Harvard Medical School

Summary

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

Clinical Details

Official title: Clozapine vs. Olanzapine: An Effectiveness Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes in quality of life.

Secondary outcome: Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.

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.

Eligibility

Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Commonwealth Research Center, Jamaica Plain, Massachusetts 02130, United States
Additional Information

Starting date: August 1998
Last updated: April 6, 2015

Page last updated: August 23, 2015

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