N/A
N=674
STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse
Major Depressive Disorder · Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00369746 ↗Enrolled (actual)
674
Serious AEs
4.6%
Results posted
May 2014
Primary outcome: Primary: Quick Inventory of Depression- Self Report 16 — 9.3; 8.9 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- citalopram (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quick Inventory of Depression- Self Report 16 |
9.3; 8.9 | — |
| SECONDARY Timeline Follow Back (TLFB) Average Drinks Per Drinking Day |
2.9 | — |
| SECONDARY Quantitative Substance Use Inventory ((SUI) |
2.4 | — |
| SECONDARY Timeline Follow Back (TLFB) Drinking Days Per 30 Days |
8.1 | — |
| SECONDARY Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day |
4.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00369746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.