Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Clozapine Response and Biogenic Amines in Schizophrenia|
- 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.
- Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
|Study Start Date:||December 1994|
|Estimated Study Completion Date:||February 2002|
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.
|United States, Massachusetts|
|Commonwealth Research Center|
|Jamaica Plain, Massachusetts, United States, 02130|
|Principal Investigator:||Alan I Green, MD||Harvard Medical School|