Status:
TERMINATED
Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.
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...
Eligibility Criteria
Inclusion
- 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
- Substance dependence in the last six months
- History of seizure or blood dyscrasia
- Major medical illness
- Pregnancy or Lactation
Key Trial Info
Start Date :
March 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00169091
Start Date
March 1 1996
End Date
October 1 2003
Last Update
April 7 2015
Active Locations (1)
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1
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130