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

Major Depressive Disorder Clinical Trial

Official title:

Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369746
• Other study ID #: #5173
• Secondary ID: R01AA013303
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2006
• Last updated: April 9, 2014
• Start date: September 2006
• Est. completion date: February 2009

Study information

• Verified date: December 2011
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• citalopram
tablets, 60 mg maximum, daily, 12 weeks

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depression- Self Report 16	Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit; Scale range: Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16; Total scoring ranges (0-48): 0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression	study exit visit, at Week 12	No
Secondary	Timeline Follow Back (TLFB) Average Drinks Per Drinking Day	This variable reports average drinks/drinking day in a pre-defined time frame.	30 days	No
Secondary	Quantitative Substance Use Inventory ((SUI)	Quantitative Substance Use Inventory ((SUI) Measure substance use; Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days	30 days	No
Secondary	Timeline Follow Back (TLFB) Drinking Days Per 30 Days	This variable reports drinking days in a pre-defined time frame.	30 days	No
Secondary	Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day	This variable reports maximum drinks per drinking day in a pre-defined time frame.	30 days	No