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

New York State Psychiatric Institute

Status

Completed

Conditions

Major Depressive Disorder

Alcohol Use Disorder

Treatments

Drug: citalopram

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00369746

#5173

R01AA013303 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

674 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.