Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

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

Detailed Description
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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.

Official Title
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Clozapine or Haloperidol in First Episode Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Clozapine
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clozapine<br>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. | Drug: Clozapine<br>* 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.<br>* Other names: Clozaril;|
| Active Comparator: Haloperidol<br>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. | Drug: Haloperidol<br>* 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.<br>* Other names: Haldol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Psychiatric Rating Scale | This study will use the 24 item BPRS | Weekly during the Acute Treatment Phase and every two weeks in Follow-Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clozapine, Haloperidol, Schizophrenia