Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Clozapine (Drug); Chlorpromazine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Alan I Green, MD, Principal Investigator, Affiliation: Harvard University
Summary
This study will examine the physical response to clozapine or chlorpromazine in people with
schizophrenia that has not improved with treatment.
Clinical Details
Official title: Clozapine Response and Biogenic Amines in Schizophrenia
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Commonwealth Research Center, Jamaica Plain, Massachusetts 02130, United States
Additional Information
Related publications: Green AI, Alam MY, Boshes RA, Waternaux C, Pappalardo KM, Fitzgibbon ME, Tsuang MT, Schildkraut JJ. Haloperidol response and plasma catecholamines and their metabolites. Schizophr Res. 1993 Jun;10(1):33-7. Green AI, Alam MY, Sobieraj JT, Pappalardo KM, Waternaux C, Salzman C, Schatzberg AF, Schildkraut JJ. Clozapine response and plasma catecholamines and their metabolites. Psychiatry Res. 1993 Feb;46(2):139-49. Review.
Starting date: December 1994
Ending date: February 2002
Last updated: February 21, 2006
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