Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Schizophrenia Clinical Trial

Official title:

Clozapine Response and Biogenic Amines in Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00169039
• Other study ID #: R01MH049891
• Secondary ID: R01MH049891
• Status: Terminated
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: April 6, 2015
• Start date: December 1994
• Est. completion date: February 2002

Study information

• Verified date: April 2015
• Source: Harvard Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Clozapine

• Chlorpromazine

Locations

Country	Name	City	State
United States	Commonwealth Research Center	Jamaica Plain	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Harvard Medical School	Commonwealth Research Center, Massachusetts, Dartmouth-Hitchcock Medical Center, National Institute of Mental Health (NIMH), Novartis

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.