Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

NCT ID: NCT00169091

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-03-31
• Study Completion Date: 2003-10-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Clozapine

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Haloperidol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Clozaril; Haldol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: collaborator

Commonwealth Research Center, Massachusetts

OTHER

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Responsible Party

AlanGreen

Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan I Green, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

Commonwealth Research Center

Jamaica Plain, Massachusetts, United States

Countries

United States

References

Green AI, Schildkraut JJ. Should clozapine be a first-line treatment for schizophrenia? The rationale for a double-blind clinical trial in first-episode patients. Harv Rev Psychiatry. 1995 May-Jun;3(1):1-9. doi: 10.3109/10673229509017159.

Reference Type: BACKGROUND

PMID: 9384923 (View on PubMed)

Other Identifiers

R01MH052376

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH052376

Identifier Type: NIH

Identifier Source: org_study_id

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