Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Schizophrenia Clinical Trial

Official title:

Clozapine or Haloperidol in First Episode Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00169091
• Other study ID #: R01MH052376
• Secondary ID: R01MH052376
• Status: Terminated
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: April 6, 2015
• Start date: March 1996
• Est. completion date: October 2003

Study information

• Verified date: April 2015
• Source: Harvard Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: October 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Commonwealth Research Center	Jamaica Plain	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Harvard Medical School	Commonwealth Research Center, Massachusetts, Dartmouth-Hitchcock Medical Center, National Institute of Mental Health (NIMH), Novartis

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No