Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-12-31

Study Completion Date

2002-02-28

Brief Summary

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This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.

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Detailed Description

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This is a longitudinal double-blind 12-week study of the clinical and biochemical response to clozapine or chlorpromazine in a group of treatment-refractory schizophrenic patients.

The study has 4 phases: (1) A recruitment period; (2) a period of discontinuation of psychotropic medication; (3) a drug-washout period; and (4) a 12-week double-blind trial of clozapine or chlorpromazine.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Clozapine

Intervention Type DRUG

Chlorpromazine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 19-60 years of age
* Diagnosis of schizophrenia
* BPRS score \> 50
* Clinical Global Impressions rating \> 4
* One of the following: BPRS items rated greater than or equal to 4, conceptual disorganization, suspiciousness, hallucinations, unusual thought content.
* At least 2 six-week trials of different neuroleptics given at a dosage equivalent to at least 600 mg per day of chlorpromazine OR at least 1 eight-week trial of a neuroleptic given at a dosage equivalent to at least 800 mg per day of chlorpromazine.
* The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent.

Exclusion Criteria

* History of substance dependence within the past 2 months
* Major medical problems precluding the use of clozapine
* Pregnancy or lactation
* A serious suicide/homicide risk

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No