Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

NCT ID: NCT00169065

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Study Completion Date

2002-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clozapine

Clozapine or olanzapine in treatment resistant schizophrenia

Group Type ACTIVE_COMPARATOR

Clozapine

Intervention Type DRUG

olanzapine

clozapine or olanzapine in treatment resistant schizophrenia

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Interventions

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Clozapine

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

Commonwealth Research Center, Massachusetts

OTHER

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role lead

Responsible Party

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AlanGreen

Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan I Green, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

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Commonwealth Research Center

Jamaica Plain, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH049891

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH049891

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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