Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Phase 4

Terminated

• Conditions: Schizophrenia

• Registration Number: NCT00169039
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

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.

Study Timeline

• Study Start: 1994-12
• Study Completion: 2002-02
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.

Trial Locations

Locations (1)

Commonwealth Research Center; 🇺🇸 Jamaica Plain, Massachusetts, United States