Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169039
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : April 7, 2015
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts
Information provided by (Responsible Party):
AlanGreen, Harvard Medical School

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169039

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
Principal Investigator: Alan I Green, MD Harvard Medical School

Responsible Party: AlanGreen, Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth, Harvard Medical School Identifier: NCT00169039     History of Changes
Other Study ID Numbers: R01MH049891 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by AlanGreen, Harvard Medical School:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents