Treatment Evaluation of Alcohol and Mood

Phase 2

• Conditions: Alcoholism; Depression; Mental Health - Depression; Mental Health - Addiction

• Registration Number: ACTRN12606000413527
• Lead Sponsor: Professor Doug Sellman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Currently meets the DSM-IV (APA 1994) criteria for alcohol dependence (i.e. the presence of at least 3/7 DSM-IV criteria for alcohol dependence in the month prior to presentation; -currently meets the the DSM-IV criteria for major depression (i.e. the presence of at least 5/9 DSM-IV criteria for major depression in month prior to presentation and has no history of manic episodes);-has a MADRS score of 20 plus at presentation.

Exclusion Criteria

Any history of daily or nearly daily intravenous drug use for more than 2 weeks, or use of any opioid drugs in the previous 4 weeks; -a history of psychosis of any sort;-a clear history of mania or hypomania based on the DSM-IV criteria;-signifcant current risk of suicide or homicide;-severe psychiatric symptoms requiring hospitalisation;-evidence of any significant cerebral, renal, thyroid or cardiac disease;-taken disulfiram, calcium carbimide, naltrexone, or antidepressant medication during the past 4 weeks;-a history of alcoholic liver disease;-if premenopausal female: pregnancy, nursing or refusing to use a reliable method of birth control;-in prison or on home detention at any time during the past 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for alcohol use will be the percent days abstinent[Measured every three weeks during the trial, with primary outcome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.];The primary outcome measure for depressive symptoms will be scores on the Montgomery and Asberg Depression Rating Scale (MADRS) score.[Measured every three weeks during the trial, with primary outcome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome drinking measures will be based on sessional drinking data and will include mean drinks per drinking day and percentage of heavy drinking days during the follow-up period.[These will be measured every three weeks during the trial, with primary ouctome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.];Secondary depression outcome measures will be based on MADRS scores and Symptoms Checklist-90 (SCL-90) data, and will include catergorisation of responders and non-responders using a criterion of a MADRS score of 10 or less.[These will be measured every three weeks during the trial, with primary ouctome measures at pharmacotherapy termination, and then 12 weeks and 12 months post-pharmacotherapy.]