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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00369746
First received: August 24, 2006
Last updated: February 23, 2009
Last verified: February 2009
  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
Non-Psychotic Major Depressive Disorder
Alcohol Use Disorder
Drug: citalopram
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • Timeline Follow Back (TLFB)
  • Quantitative Substance Use Inventory ((SUI)
  • Treatment Services Review (TSR)

Estimated Enrollment: 60
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 DSM-IV diagnoses as a primary condition: Schizophrenia, Schizoaffective Disorder, Bipolar I, II, and NOS, Anorexia nervosa, Bulimia, Obsessive Compulsive Disorder
  • Patients abusing substances which require detoxification. ASAM 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369746

Locations
United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
Investigators
Study Director: Patrick J. McGrath, MD New York State Psychiatric Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00369746     History of Changes
Other Study ID Numbers: NIAAA-GRE-13303-01, NIH Grant RO1 AA13303-01
Study First Received: August 24, 2006
Last Updated: February 23, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Depression
Alcohol Abuse
Alcohol Dependence
STAR*D

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 April 16, 2014