Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

Harvard Medical School (HMS and HSDM)38 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Schizophrenia

Interventions

ClozapineDRUG

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 (1)

Commonwealth Research Center

Jamaica Plain, Massachusetts, United States

Outcomes

Primary Outcomes

Changes in quality of life.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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