NCT00369746

STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse

Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 674 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if having an alcohol use disorder affects recovery from depression, and also whether recovery from depression in patients who have alcohol use disorders is also accompanied by improvement in the alcohol use disorder.

Detailed description

This is an extension of the multi-site sub-study of the National Institute of Mental Health (NIMH) protocol, Sequenced Treatment Alternatives to Relieve Depression (STAR\*D), which utilized the infrastructure of the Depression Trials Network to enroll 4,000 subjects diagnosed with Major Depressive Disorder. These subjects initially received 12 weeks of treatment with the anti-depressant citalopram. The thrust of this study was to test treatment algorithms for those subjects who did not respond adequately to initial monotherapy treatment with citalopram or who were unable to tolerate it. The parent protocol also contained several ancillary studies, including a sub-study of subjects with co-morbid alcohol use disorders, which enrolled 130 subjects. Treatment response data was collected at multiple intervals during the 12 week treatment period on depressed subjects both with and without a co-morbid alcohol use disorder. Comparison: Treatment outcome measures of subjects diagnosed with Major Depressive Disorder will be compared to treatment outcome measures of subjects diagnosed with Major Depressive Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment period. This comparison will show whether having a co-morbid alcohol use disorder affects recovery from depression. In addition, alcohol use data of depressed subjects who demonstrated a positive response to anti-depressant treatment will be compared with alcohol use data of depressed subjects who did not have positive treatment outcomes. This comparison will show whether recovery from depression is associated with improvement in the co-morbid alcohol use disorder.

Conditions

• Major Depressive Disorder
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	citalopram	tablets, 60 mg maximum, daily, 12 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2006-08-29
• Last updated: 2014-05-09
• Results posted: 2014-05-09

Locations

1 site across 1 country: United States