Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia (COES)

Harvard Medical School (HMS and HSDM)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Clozapine

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00169065

R01MH049891 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Clozapine

Active Comparator group

Description:

Clozapine or olanzapine in treatment resistant schizophrenia

Treatment:

Drug: Clozapine

olanzapine

Active Comparator group

Description:

clozapine or olanzapine in treatment resistant schizophrenia

Treatment:

Drug: Olanzapine