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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 (HMS and HSDM)|