Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

This study has been terminated.

Sponsor:

Collaborators:

National Institute of Mental Health (NIMH)

Dartmouth-Hitchcock Medical Center

Commonwealth Research Center, Massachusetts

Novartis

Information provided by (Responsible Party):

AlanGreen, Harvard Medical School

ClinicalTrials.gov Identifier:

NCT00169039

First received: September 10, 2005

Last updated: April 6, 2015

Last verified: April 2015

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment
Official Title:	Clozapine Response and Biogenic Amines in Schizophrenia

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Chlorpromazine Chlorpromazine hydrochloride Clozapine

U.S. FDA Resources

Further study details as provided by AlanGreen, Harvard Medical School:

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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Harvard Medical School

National Institute of Mental Health (NIMH)

Dartmouth-Hitchcock Medical Center

Commonwealth Research Center, Massachusetts

Novartis

Investigators


Principal Investigator:	Alan I Green, MD	Harvard Medical School

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.


Responsible Party:	AlanGreen, Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth, Harvard Medical School
ClinicalTrials.gov Identifier:	NCT00169039 History of Changes
Other Study ID Numbers:	R01MH049891 ( U.S. NIH Grant/Contract )
Study First Received:	September 10, 2005
Last Updated:	April 6, 2015

Keywords provided by AlanGreen, Harvard Medical School:


Clozapine Chlorpromazine Schizophrenia Biochemistry

Additional relevant MeSH terms:


Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Clozapine Chlorpromazine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents	Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Antagonists GABA Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Dopamine Antagonists Dopamine Agents

ClinicalTrials.gov processed this record on September 21, 2017

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