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

NCT ID: NCT00369746

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 674 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-02-28

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Alcohol and major depression, citalopram

Patients with alcohol use disorder and major depression, treated with citalopram tablets, 20-60 mg, once daily, for 12 weeks

citalopram

Intervention Type: DRUG

tablets, 60 mg maximum, daily, 12 weeks

Major Depression, citalopram

Patients with major depression, treated with citalopram tablets 20-60 mg daily, for 12 weeks

citalopram

Intervention Type: DRUG

tablets, 60 mg maximum, daily, 12 weeks

Interventions

citalopram

tablets, 60 mg maximum, daily, 12 weeks

Intervention Type: DRUG

Other Intervention Names

Celexa

Eligibility Criteria

Inclusion Criteria

• Males and females aged 18- 75 years
• Meets criteria for Non-psychotic Major Depression
• Signs informed consent and able to comply with study
• Hamilton Depression Scale (HAM-D 17) >14
• Endorses any drinking items on Short Michigan Alcoholism Screening Test

Exclusion Criteria

• Pregnant women and women of childbearing potential who are not using a medically accepted means of contraception.
• Women who are breast feeding
• Patients with suicidal ideation that require hospitalization
• Patients with unstable physical disorders
• Patients with a history of allergy to citalopram or history of non-response to an adequate dose of citalopram in the current episode.
• Patients meeting criteria for the following diagnoses as a primary condition: Schizophrenia, Schizoaffective Disorder, Bipolar I, II, and Not Otherwise Specified, Anorexia nervosa, Bulimia, Obsessive Compulsive Disorder
• Patients abusing substances which require detoxification. American Society for Addiction Medicine standards for detoxification will be used (Level III.7). Patients with substance abuse who are in substance abuse treatment will be eligible.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J. McGrath, MD

Role: STUDY_DIRECTOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

R01AA013303

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#5173

Identifier Type: -

Identifier Source: org_study_id