NCT00302133|CompletedPhase 1/2Results
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Sponsor study identifier
Secondary identifiers
interventional
88
1 country
1
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
July 2013
Actual (reported)The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 9, 2006
Actual (reported)March 13, 2006
Actual (reported)May 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 2013
Actual (reported)July 2013
Actual (reported)November 5, 2014
Actual (reported)Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
12 weeks
% Subjects Abstinent
12 weeks
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate
Placebo comparator one capsule daily for 12 weeks add on to valproate
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks
Placebo arm
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
High early drop-out rate leading to small number of subjects analyzed.
Ihsan M Salloum, MD, MPH
University of Miami
88 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2006
First Posted
March 13, 2006
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
May 17, 2016
Results First Posted
November 5, 2014
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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