Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Clozapine; Drug: Chlorpromazine	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	66 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Clozapine Response and Biogenic Amines in Schizophrenia
Study Start Date :	December 1994
Study Completion Date :	February 2002

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted:	September 15, 2005
Last Update Posted:	April 7, 2015
Last Verified:	April 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