Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
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| ClinicalTrials.gov Identifier: NCT00169039 |
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Recruitment Status :
Terminated
First Posted : September 15, 2005
Last Update Posted : April 7, 2015
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Sponsor:
Harvard Medical School (HMS and HSDM)
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 (HMS and HSDM)
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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 |
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 Genetics related topics:
Schizophrenia
MedlinePlus related topics:
Schizophrenia
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.
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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
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 ClinicalTrials.gov identifier (NCT number): NCT00169039
Locations
| United States, Massachusetts | |
| Commonwealth Research Center | |
| Jamaica Plain, Massachusetts, United States, 02130 | |
Sponsors and Collaborators
Harvard Medical School (HMS and HSDM)
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 (HMS and HSDM) |
Publications:
| Responsible Party: | AlanGreen, Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth, Harvard Medical School (HMS and HSDM) |
| ClinicalTrials.gov Identifier: | NCT00169039 |
| Other Study ID Numbers: |
R01MH049891 ( U.S. NIH Grant/Contract ) 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 (HMS and HSDM):
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Clozapine Chlorpromazine Schizophrenia Biochemistry |
Additional relevant MeSH terms:
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Chlorpromazine Clozapine 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 |