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. |
ClinicalTrials.gov Identifier: NCT00169039 |
Recruitment Status :
Terminated
First Posted : September 15, 2005
Last Update Posted : April 7, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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

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, Learn About Clinical Studies.
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

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
United States, Massachusetts | |
Commonwealth Research Center | |
Jamaica Plain, Massachusetts, United States, 02130 |
Principal Investigator: | Alan I Green, MD | Harvard Medical School (HMS and HSDM) |
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 |
Clozapine Chlorpromazine Schizophrenia Biochemistry |
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 |