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Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Information source: Harvard Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Clozapine (Drug); Haloperidol (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Harvard Medical School

Official(s) and/or principal investigator(s):
Alan I Green, MD, Principal Investigator, Affiliation: Harvard Medical School


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

Clinical Details

Official title: Clozapine or Haloperidol in First Episode Schizophrenia

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

Primary outcome: Brief Psychiatric Rating Scale

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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 and Contacts

Commonwealth Research Center, Jamaica Plain, Massachusetts 02130, United States
Additional Information

Related publications:

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.

Starting date: March 1996
Last updated: April 6, 2015

Page last updated: August 23, 2015

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