Jamaica Plain, Massachusetts 02130

  • Schizophrenia

Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00169091


Primary Contact:

Principal Investigator
Alan I Green, MD
Harvard Medical School


Backup Contact:

N/A


Location Contact:

Jamaica Plain, Massachusetts 02130
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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