Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Sponsor

Harvard Medical School (HMS and HSDM) (Other)

Overall Status

Terminated

CT.gov ID

NCT00169039

Collaborator

National Institute of Mental Health (NIMH) (NIH), Dartmouth-Hitchcock Medical Center (Other), Commonwealth Research Center, Massachusetts (Other), Novartis (Industry)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Clozapine Drug: Chlorpromazine	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Clozapine Response and Biogenic Amines in Schizophrenia

Study Start Date :

Dec 1, 1994

Study Completion Date :

Feb 1, 2002

Outcome Measures

Primary Outcome Measures

Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale. []

Secondary Outcome Measures

Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.