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