Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00169091|
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Clozapine Drug: Haloperidol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clozapine or Haloperidol in First Episode Schizophrenia|
|Study Start Date :||March 1996|
|Actual Primary Completion Date :||September 2003|
|Study Completion Date :||October 2003|
Clozapine 12.5-300 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 12.5 mg on Day 1 to up to 300 mg on Day 12.
Other Name: Clozaril
Active Comparator: Haloperidol
Haloperidol 2-12 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 2 mg on Day 1 to up to 12 mg on Day 12.
Other Name: Haldol
- Brief Psychiatric Rating Scale [ Time Frame: Weekly during the Acute Treatment Phase and every two weeks in Follow-Up ]This study will use the 24 item BPRS
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169091
|United States, Massachusetts|
|Commonwealth Research Center|
|Jamaica Plain, Massachusetts, United States, 02130|
|Principal Investigator:||Alan I Green, MD||Harvard Medical School|