Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

NCT00169091 | Terminated Phase 4

• 1 other identifier: R01MH052376
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Clozapine; Haloperidol; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Clozapine

EXPERIMENTAL

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

Haloperidol

ACTIVE COMPARATOR

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

Interventions

Clozapine 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.

Also known as: Clozaril

Clozapine

Haloperidol 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.

Also known as: Haldol

Haloperidol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• National Institute of Mental Health (NIMH): collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Commonwealth Research Center, Massachusetts: collaborator
• Novartis: collaborator

Study Sites (1)

Commonwealth Research Center

Jamaica Plain, Massachusetts, 02130, United States

Location

Related Publications (1)

• 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.

  PMID: 9384923 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Clozapine; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Alan I Green, MD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 1996
• Primary Completion: September 1, 2003
• Study Completion: October 1, 2003
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)