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Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) Dartmouth-Hitchcock Medical Center Harvard University Commonwealth Research Center Novartis |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00169039 |
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
Condition | Intervention | Phase |
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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 |
Estimated Enrollment: | 66 |
Study Start Date: | December 1994 |
Estimated Study Completion Date: | February 2002 |
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.
Ages Eligible for Study: | 19 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Commonwealth Research Center | |
Jamaica Plain, Massachusetts, United States, 02130 |
Principal Investigator: | Alan I Green, MD | Harvard University |
Study ID Numbers: | MH49891 |
Study First Received: | September 10, 2005 |
Last Updated: | February 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00169039 |
Health Authority: | United States: Federal Government |
Clozapine Chlorpromazine Schizophrenia Biochemistry |
Schizophrenia Dopamine Mental Disorders Clozapine |
Chlorpromazine Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions GABA Antagonists Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses GABA Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |