NCT00563797|CompletedPhase 3ResultsDMC
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Sponsor study identifier
interventional
21
1 country
1
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day) versus placebo in reducing depressive and alcohol symptoms in patients with depression and co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce depressive symptoms and decrease alcohol consumption compared to placebo in patients with depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake inhibitor (SSRI).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
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.
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 21, 2007
Actual (reported)November 26, 2007
Actual (reported)July 2014
Actual (reported)July 2014
Actual (reported)April 18, 2016
Actual (reported)Number of Drinking Days
Measured with time line follow back measures
25 weeks
Depression - Measured Using the HAMD Total Score
The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients. Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to \>23 (Very Severe Depression)
12 weeks
Mean Percentage of Number of Drinking Days by Smoking Status
25 weeks
Mean Percentage of Heavy Drinking Days by Smoking
25 weeks
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
mecamylamine 10mg/day for 12 weeks
Placebo pill
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Elizabeth Ralevski, Ph.D.
Yale University
21 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2007
First Posted
November 26, 2007
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacological Treatment for Alcoholism
Contact the study team to confirm eligibility.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
April 18, 2016
Results First Posted
April 18, 2016
Record last verified: 2016-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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