Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Harvard Medical School (HMS and HSDM)

Status and phase

Terminated

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Chlorpromazine

Drug: Clozapine

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00169039

R01MH049891 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

19 to 60 years old

Volunteers

No Healthy Volunteers

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