Clozapine Response and Biogenic Amines in Schizophrenia

Harvard Medical School (HMS and HSDM)1 site in 1 country66 target enrollmentDecember 1994

ConditionsSchizophrenia

DrugsClozapine Chlorpromazine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Harvard Medical School (HMS and HSDM)
Enrollment: 66
Locations: 1
Primary Endpoint: 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.
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

December 1994

End Date

February 2002

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Harvard Medical School (HMS and HSDM)

Responsible Party

Principal Investigator

AlanGreen

Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth

Harvard Medical School (HMS and HSDM)

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.