Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Phase 4TerminatedNCT00169091

Harvard Medical School (HMS and HSDM)32 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia

Interventions

ClozapineDRUG

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.

HaloperidolDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Commonwealth Research Center

Jamaica Plain, Massachusetts, United States

Outcomes

Primary Outcomes

Brief Psychiatric Rating Scale

This study will use the 24 item BPRS

Time frame: Weekly during the Acute Treatment Phase and every two weeks in Follow-Up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.