Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

• Status: Terminated
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard Medical School; Harvard Medical School (HMS and HSDM)
• Collaborators: Commonwealth Research Center, Massachusetts; Dartmouth-Hitchcock Medical Center; National Institute of Mental Health (NIMH); Novartis
• Treatments: Chlorpromazine; Clozapine

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