NCT00169026|TerminatedPhase 4
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Sponsor study identifier
interventional
64
1 country
1
Study Start
May 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
The purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1999
Date type not reportedThis date has not been verified as actual or estimated.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 10, 2005
Actual (reported)September 15, 2005
Actual (reported)Self report using the weekly Time Line Follow Back; Alcohol Use Scale and Drug Use Scale obtained by clinician and key informant; breathalyzer and urine drug screen. Monthly consensus in substance use rating; monthly CDT and clozapine blood levels.
Clinical Measures: Brief Psychiatric Rating Scale; Scale for the Assessment of Negative Symptoms; and Clinical Global Impression; neurological side affects, cognitive assessment and quality of life measure.
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Commonwealth Research Center
Jamaica Plain, Massachusetts, 02130, United States
Green AI, Zimmet SV, Strous RD, Schildkraut JJ. Clozapine for comorbid substance use disorder and schizophrenia: do patients with schizophrenia have a reward-deficiency syndrome that can be ameliorated by clozapine? Harv Rev Psychiatry. 1999 Mar-Apr;6(6):287-96. doi: 10.3109/10673229909017206.
Alan I Green, MD
Harvard Medical School (HMS and HSDM)
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
May 1999
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
January 2004
Switching Antipsychotics: Abrupt Discontinuation Versus Overlap
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This date has not been verified as actual or estimated.
Last Updated
March 14, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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