Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Clozapine or Haloperidol in First Episode Schizophrenia|
- Clinical Measures: Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Clinical Global Impression, and a neuropsychological battery.
- Quality of Life Scale ; safety assessment included complete blood counts, and extrapyramidal symptom scales. Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites and serum prolactin and plasma cortisol.
|Study Start Date:||March 1996|
|Estimated Study Completion Date:||July 2003|
This is a longitudinal double blind, 2- 5 year study of the clinical, neuroendocrine and biochemical response to clozapine (CLOZ) and haloperidol (HAL) in a group of "first episode" schizophrenic (RDC) patients. Within the protocol, we compare the differential effects of the two drugs over the short term (12 weeks) and the long-term (2-5 years); we evaluate the relationship between change in prolactin level and clinical response of the patients; and we search for biochemical predictors and correlates of clinical response. To achieve the study aims, we employ a drug-washout period, a 12-week acute treatment period; and an 88 - 260 week follow-up period.
|United States, Massachusetts|
|Commonwealth Research Center|
|Jamaica Plain, Massachusetts, United States, 02130|
|Principal Investigator:||Alan I Green, MD||Harvard Medical School|