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Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) Dartmouth-Hitchcock Medical Center Harvard University Commonwealth Research Center Novartis |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00169091 |
This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.
Condition | Intervention | Phase |
Schizophrenia |
Drug: Clozapine Drug: Haloperidol |
Phase IV |
MedlinePlus related topics: | Schizophrenia |
ChemIDplus related topics: | Clozapine Haloperidol Haloperidol decanoate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clozapine or Haloperidol in First Episode Schizophrenia |
Estimated Enrollment: | 44 |
Study Start Date: | March 1996 |
Estimated Study Completion Date: | July 2003 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |||||
Commonwealth Research Center | |||||
Jamaica Plain, Massachusetts, United States, 02130 |
National Institute of Mental Health (NIMH) |
Dartmouth-Hitchcock Medical Center |
Harvard University |
Commonwealth Research Center |
Novartis |
Principal Investigator: | Alan I Green, MD | Harvard University |
Study ID Numbers: | MH52376 |
First Received: | September 10, 2005 |
Last Updated: | February 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00169091 |
Health Authority: | United States: Federal Government |
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