Status:
TERMINATED
Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Conditions:
Schizophrenia
Eligibility:
All Genders
19-60 years
Phase:
PHASE4
Brief Summary
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
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 ph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1994
Trial Type :
INTERVENTIONAL
End Date :
February 1 2002
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00169039
Start Date
December 1 1994
End Date
February 1 2002
Last Update
April 7 2015
Active Locations (1)
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1
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130