Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 10, 2005

Last Updated Date

February 21, 2006

Start Date ^ICMJE

December 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00169039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Official Title ^ICMJE

Clozapine Response and Biogenic Amines in Schizophrenia

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Clozapine
Drug: Chlorpromazine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00169039

Responsible Party

Study ID Numbers ^ICMJE

MH49891

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Dartmouth-Hitchcock Medical Center
Harvard University
Commonwealth Research Center
Novartis

Investigators ^ICMJE

Principal Investigator:

Alan I Green, MD

Harvard University

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP