Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Clozapine (Drug); Haloperidol (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Alan I Green, MD, Principal Investigator, Affiliation: Harvard University
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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical Measures: Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Clinical Global Impression, and a neuropsychological battery.
Secondary outcome: Quality of Life Scale ; safety assessment included complete blood counts, and extrapyramidal symptom scales. Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites and serum prolactin and plasma cortisol.
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
Ending date: July 2003
Last updated: February 21, 2006
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