Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Clozapine Response and Biogenic Amines in Schizophrenia

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169039

Enrollment

Registered

2005-09-15

Start date

1994-12-31

Completion date

2002-02-28

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Clozapine, Chlorpromazine, Schizophrenia, Biochemistry

Brief summary

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

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.

Interventions

DRUGClozapine

DRUGChlorpromazine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026