NCT00169091

Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Clozapine or Haloperidol in First Episode Schizophrenia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Clozapine	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.
DRUG	Haloperidol	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.

Timeline

• Start date: 1996-03-01
• Primary completion: 2003-09-01
• Completion: 2003-10-01
• First posted: 2005-09-15
• Last updated: 2015-04-07

Locations

1 site across 1 country: United States