Clinical trial NCT00369746: STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse
Official title: Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Alcohol Use Disorder
Keywords: Depression
Alcohol Abuse
Alcohol Dependence
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-08-29
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the Sequenced Treatment Alternatives to Relieve Depression

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.

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.

Primary outcomes:
measure: Quick Inventory of Depression- Self Report 16
timeFrame: study exit visit, at Week 12
Secondary outcomes:
measure: Timeline Follow Back (TLFB) Average Drinks Per Drinking Day
timeFrame: 30 days
measure: Quantitative Substance Use Inventory ((SUI)
timeFrame: 30 days
measure: Timeline Follow Back (TLFB) Drinking Days Per 30 Days
timeFrame: 30 days
measure: Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Patrick J. McGrath, MD
role: STUDY_DIRECTOR
References: