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
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clozapine or Haloperidol in First Episode Schizophrenia|
- Brief Psychiatric Rating Scale [ Time Frame: Weekly during the Acute Treatment Phase and every two weeks in Follow-Up ] [ Designated as safety issue: No ]This study will use the 24 item BPRS
|Study Start Date:||March 1996|
|Estimated Study Completion Date:||October 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
Clozapine 12.5-300 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 12.5 mg on Day 1 to up to 300 mg on Day 12.
Other Name: Clozaril
Active Comparator: Haloperidol
Haloperidol 2-12 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 2 mg on Day 1 to up to 12 mg on Day 12.
Other Name: Haldol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169091
|United States, Massachusetts|
|Commonwealth Research Center|
|Jamaica Plain, Massachusetts, United States, 02130|
|Principal Investigator:||Alan I Green, MD||Harvard Medical School|