STAR*D Alcohol: Treatment of Depression Concurrent With Alcohol Abuse
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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 |
- 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)
| 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) |
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 |
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| 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 |
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 May 19, 2013