Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Phase 4

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Clozapine; Drug: Haloperidol

• Registration Number: NCT00169091
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

Brief 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.

Study Timeline

• Study Start: 1996-03
• Primary Completion: 2003-09
• Study Completion: 2003-10
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• RDC diagnosis of schizophrenia
• Men and women, without regard to race/ethnicity,
• Aged 18-45
• Acutely psychotic with a score of at least 3 on one of the psychotic scale items of the Brief Psychiatric Rating Scale (BPRS) (hallucinations, delusions, conceptual disorganization) and a total BPRS of > 21 (on a 0 - 6 scale);
• Require treatment with neuroleptic drugs on a clinical basis;
• The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
• Be within the first episode of a psychotic disorder;
• Have a history of neuroleptic treatment of < 12 weeks;
• Likely to remain in the study for 2 years.

Exclusion Criteria

• Substance dependence in the last six months
• History of seizure or blood dyscrasia
• Major medical illness
• Pregnancy or Lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clozapine	Clozapine	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.
Haloperidol	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.

Primary Outcome Measures

Name	Time	Method
Brief Psychiatric Rating Scale	Weekly during the Acute Treatment Phase and every two weeks in Follow-Up	This study will use the 24 item BPRS

Trial Locations

Locations (1)

Commonwealth Research Center; 🇺🇸 Jamaica Plain, Massachusetts, United States