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Sponsors and Collaborators: |
Massachusetts General Hospital National Alliance for Research on Schizophrenia and Depression |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00452543 |
This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence.
The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.
Condition | Intervention | Phase |
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Major Depressive Disorder Alcohol Abuse Alcohol Dependence |
Drug: acamprosate Drug: escitalopram Behavioral: Medical management Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Study of Acamprosate Added to Escitalopram and Behavioral Treatment in Major Depressive Disorder (MDD) With Comorbid Alcohol Abuse/Dependence |
Estimated Enrollment: | 40 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: acamprosate
Acamprosate 333mg, 2 capsules po tid, for 12 weeks
Drug: escitalopram
Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg po qd with the possibility of increasing to 30mg po qd.
Behavioral: Medical management
Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).
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2: Placebo Comparator |
Drug: escitalopram
Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg po qd with the possibility of increasing to 30mg po qd.
Behavioral: Medical management
Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).
Drug: Placebo
Placebo, 2 capsules po tid, for 12 weeks
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Depression and alcohol use disorders contribute to a significant proportion of the burden of disease, in the United States and abroad. Patients who suffer from co-morbid depression and alcohol abuse/dependence have illnesses that are more severe, persistent and costly than people with either depression or an alcohol use disorder alone. The treatment of these patients remains controversial. Several studies have demonstrated that antidepressants can be safe and efficacious in the treatment of depression in people who continue to drink, and it is now considered the standard of care to provide such treatment. Other studies have shown that pharmacotherapy with naltrexone or acamprosate can help reduce drinking in alcoholics without co-morbid depression. A logical extension of these findings would be to study the treatment of depressed alcoholics with dual pharmacotherapy, combining an anti-depressant with a medication aimed at treating the alcohol use disorder.
We will conduct a randomized, double-blind, placebo controlled trial of escitalopram plus acamprosate and behavioral treatment vs. escitalopram plus placebo and behavioral treatment in 20 depressed alcoholics. Outcome measures will include depression, alcohol use and global functioning.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician.
These patients will be immediately referred to appropriate clinical treatment.
Contact: Janet M. Witte, MD, MPH | 617-726-5104 | jwitte@partners.org |
Contact: Soo Jeong Youn, BA | 617-724-2936 | syoun@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Soo Jeong Youn, BA 617-724-2936 syoun@partners.org | |
Principal Investigator: Janet M Witte, MD, MPH |
Principal Investigator: | Janet M Witte, MD | Massachusetts General Hospital |
Principal Investigator: | Nicholas Bolo, PhD | Mclean Hospital |
Responsible Party: | Massachusetts General Hospital ( Janet Witte, MD ) |
Study ID Numbers: | 2006-P-001592/1 |
Study First Received: | March 26, 2007 |
Last Updated: | July 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00452543 History of Changes |
Health Authority: | United States: Institutional Review Board |
Major depressive disorder Alcoholism Alcohol abuse Alcohol dependence |
Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Disorders of Environmental Origin Depressive Disorder, Major Cholinergic Agents Depressive Disorder Serotonin Uptake Inhibitors Citalopram Serotonin Behavioral Symptoms |
Acamprosate Muscarinic Antagonists Mental Disorders Alcoholism Substance-Related Disorders Mood Disorders Alcohol-Related Disorders Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents Ethanol |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Antiparkinson Agents Depressive Disorder, Major Cholinergic Agents Acamprosate Pathologic Processes Mental Disorders |
Therapeutic Uses Substance-Related Disorders Alcohol-Related Disorders Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents Disease Depression Depressive Disorder Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Serotonin Agents |