Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452543
Status:
COMPLETED
Last Update Posted:
2012-07-09
First Post:
2007-03-26
Brief Title:
Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of Acamprosate Added to Escitalopram and Behavioral Treatment in Major Depressive Disorder MDD With Comorbid Alcohol AbuseDependence
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population
Detailed Description:
Depression and alcohol use disorders contribute to a significant proportion of the burden of disease in the United States and abroad Patients who suffer from co-morbid depression and alcohol abusedependence have illnesses that are more severe persistent and costly than people with either depression or an alcohol use disorder alone The treatment of these patients remains controversial Several studies have demonstrated that antidepressants can be safe and efficacious in the treatment of depression in people who continue to drink and it is now considered the standard of care to provide such treatment Other studies have shown that pharmacotherapy with naltrexone or acamprosate can help reduce drinking in alcoholics without co-morbid depression A logical extension of these findings would be to study the treatment of depressed alcoholics with dual pharmacotherapy combining an anti-depressant with a medication aimed at treating the alcohol use disorder We will conduct a randomized double-blind placebo controlled trial of escitalopram plus acamprosate and behavioral treatment vs escitalopram plus placebo and behavioral treatment in 20 depressed alcoholics Outcome measures will include depression alcohol use and global functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None