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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00369746
First received: August 24, 2006
Last updated: April 9, 2014
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Alcohol Use Disorder
Drug: citalopram
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Quick Inventory of Depression- Self Report 16 [ Time Frame: study exit visit, at Week 12 ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Timeline Follow Back (TLFB) Average Drinks Per Drinking Day [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    This variable reports average drinks/drinking day in a pre-defined time frame.

  • Quantitative Substance Use Inventory ((SUI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Quantitative Substance Use Inventory ((SUI) Measure substance use

    Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days


  • Timeline Follow Back (TLFB) Drinking Days Per 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    This variable reports drinking days in a pre-defined time frame.

  • Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    This variable reports maximum drinks per drinking day in a pre-defined time frame.


Enrollment: 674
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Alcohol and major depression, citalopram
Patients with alcohol use disorder and major depression, treated with citalopram tablets, 20-60 mg, once daily, for 12 weeks
Drug: citalopram
tablets, 60 mg maximum, daily, 12 weeks
Other Name: Celexa
Major Depression, citalopram
Patients with major depression, treated with citalopram tablets 20-60 mg daily, for 12 weeks
Drug: citalopram
tablets, 60 mg maximum, daily, 12 weeks
Other Name: Celexa

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in the Sequenced Treatment Alternatives to Relieve Depression

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369746

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Study Director: Patrick J. McGrath, MD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00369746     History of Changes
Other Study ID Numbers: #5173, R01AA013303
Study First Received: August 24, 2006
Results First Received: November 23, 2011
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Depression
Alcohol Abuse
Alcohol Dependence

Additional relevant MeSH terms:
Alcohol Drinking
Depression
Depressive Disorder
Depressive Disorder, Major
Alcoholism
Drinking Behavior
Behavioral Symptoms
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Ethanol
Citalopram
Dexetimide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiparkinson Agents

ClinicalTrials.gov processed this record on July 26, 2014