Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

This study has been terminated.

First Received: September 10, 2005 Last Updated: February 21, 2006 History of Changes

Sponsor:	National Institute of Mental Health (NIMH)
Collaborators:	Dartmouth-Hitchcock Medical Center Harvard University Commonwealth Research Center Novartis
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00169039

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Drug: Clozapine Drug: Chlorpromazine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Clozapine Response and Biogenic Amines in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Chlorpromazine Chlorpromazine hydrochloride Clozapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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.

Estimated Enrollment:	66
Study Start Date:	December 1994
Estimated Study Completion Date:	February 2002

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.

Eligibility

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169039

Locations

United States, Massachusetts
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Dartmouth-Hitchcock Medical Center

Harvard University

Commonwealth Research Center

Novartis

Investigators

Principal Investigator:

Alan I Green, MD

Harvard University

More Information

Publications:

Green AI, Alam MY, Boshes RA, Waternaux C, Pappalardo KM, Fitzgibbon ME, Tsuang MT, Schildkraut JJ. Haloperidol response and plasma catecholamines and their metabolites. Schizophr Res. 1993 Jun;10(1):33-7.

Green AI, Alam MY, Sobieraj JT, Pappalardo KM, Waternaux C, Salzman C, Schatzberg AF, Schildkraut JJ. Clozapine response and plasma catecholamines and their metabolites. Psychiatry Res. 1993 Feb;46(2):139-49. Review.

Study ID Numbers:	MH49891
Study First Received:	September 10, 2005
Last Updated:	February 21, 2006
ClinicalTrials.gov Identifier:	NCT00169039 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Clozapine
Chlorpromazine
Schizophrenia
Biochemistry

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Chlorpromazine
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Gastrointestinal Agents

Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
GABA Antagonists
Serotonin Agents
Autonomic Agents
Clozapine
GABA Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009