Not Yet RecruitingPhase 2ACTRN12606000413527

Treatment Evaluation of Alcohol and Mood

A double blind placebo controlled trial of citalopram for the treatment of coexisting alcohol dependence and major depressive syndrome for patients receiving naltrexone and clinical casemanagement: impact on drinking and mood symptomotology

Sponsor

Professor Doug Sellman

Enrollment

220 participants

Start Date

Oct 1, 2006

Study Type

Interventional

Conditions

Depression Alcoholism

Summary

The combination of alcohol dependence and depression is very common in people presenting to alcohol and drug services. Pharmacotherapy offers a significant step forward in treatment. Effective antidepressant medications have been available for a number of decades, but medications which assist with relapse prevention in alcohol dependence (antidipsotropics), other than the long-established disulfiram, have only been developed more recently. There have been no published randomised controlled trials investigating the combination of these medications in people with both problems. This study will investigate the effectiveness of 12 weeks treatment of citalopram (an antidepressant) compared with placebo in a group of patients presenting to one of five alcohol and drug treatment clinics in New Zealand, who are all being treated over the same time period with naltrexone (an antidipsotropic) and clinical case management. They will all have both alcohol dependence and major depression. All participants will receive standard clinical case management, which will cover the initial 12 weeks of combined pharmacotherapy, followed by a further 12 weeks of active monitoring and support. This study will make an important contribution to evaluating the place of antidepressants in clinical practice for patients with co-occurring alcohol dependence and depression.

Eligibility

Sex: Both males and femalesMin Age: 17 YearssMax Age: 65 Yearss

Inclusion Criteria1

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 Criteria1

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.

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Interventions

Investigate the effectiveness of 12 weeks treatment of oral citalopram (20mg daily for week one, 40mg daily during weeks 2-12, with the option to increase to 60mg daily at week six) in a group of patients being treated over the same period of time with naltrexone (25mg daily for week one, 50mg daily during weeks 2-12, with the option to increase to 100mg at week six). All patients will attend clinical case management appointments at weeks 1, 2, and 3 with appointments then every three weeks until week 24.