STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse
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.
Non-Psychotic Major Depressive Disorder
Alcohol Use Disorder
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression|
- Quick Inventory of Depression - Clinician 16 (QIDS-C 16)
- Quick Inventory of Depression- Self Report 16 (QIDS-SR 16)
- Hamilton Depression Scale 17 (HAM-D 17)
- Timeline Follow Back (TLFB)
- Quantitative Substance Use Inventory ((SUI)
- Treatment Services Review (TSR)
|Study Start Date:||September 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
This is an extension of the multi-site sub-study of the NIMH engineered 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 MDD. These subjects initially received 12 weeks of treatment with the SSRI 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 STAR*D protocol also contained several ancillary studies, including a sub-study of subjects with comorbid 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 comorbid alcohol use disorder.
The extension study will enroll 60 additional subjects at St Luke's Roosevelt University Medical Practice Associates and the Depression Evaluation Service of the New York State Psychiatric Institute. The research design and methods of both the STAR*D parent and comorbid alcohol sub-study protocols are identical to the extension study during the initial 12 week citalopram treatment period, offering both comparative data (ie, depressed subjects without comorbid alcohol use disorder) as well as complementary data (ie, depressed subjects with cormorbid alcohol use disorder).
Comparison: Treatment outcome measures of subjects diagnosed with MDD will be compared to treatment outcome measures of subjects diagnosed with MDD 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.
|United States, New York|
|St. Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10019|
|Study Director:||Patrick J. McGrath, MD||New York State Psychiatric Institute|