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Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Information source: Harvard Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Clozapine (Drug); Chlorpromazine (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Harvard Medical School

Official(s) and/or principal investigator(s):
Alan I Green, MD, Principal Investigator, Affiliation: Harvard Medical School

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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
Last updated: April 6, 2015

Page last updated: August 23, 2015

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