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Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, July 2009
First Received: March 26, 2007   Last Updated: July 17, 2009   History of Changes
Sponsors and Collaborators: Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00452543
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Reduction in alcohol use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in depression score by QIDS-SR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
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).
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-VI diagnostic criteria for MDD (diagnosed with use of SCID I/P)
  2. Written informed consent
  3. Men and women aged 18-64 years
  4. Current diagnosis of alcohol abuse/dependence as per SCID I/P

Exclusion Criteria:

  1. Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician.

    These patients will be immediately referred to appropriate clinical treatment.

  2. Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy).
  3. Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease.
  4. History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc.).
  5. Clinical or lab evidence of untreated hypothyroidism.
  6. History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance use disorders (excluding alcohol and nicotine) active within the last 12 months.
  7. Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed. Patients will need to be off all antidepressants for at least two weeks by the time of the baseline visit, and four weeks for fluoxetine, and off benzodiazepines and other psychotropics for at least one week. The decision about whether to taper existing medications should be made by the individual and their primary treater based on clinical care and will not be made for purposes of study enrollment. allowed.
  8. Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials. An adequate antidepressant trial is defined as six weeks or more of treatment with escitalopram > 20mg/day or its antidepressant equivalent: (fluoxetine 40mg/day, sertraline > 100 mg/day, paroxetine > 40 mg/day, fluvoxamine > 100 mg/day, citalopram > 40 mg/day, escitalopram > 20 mg/day, venlafaxine > 150 mg/day, and duloxetine > 60 mg/day).
  9. Any depression-focused or substance-abuse focused psychotherapy (family or marital counseling would be allowed).
  10. Patients who have taken an investigational psychotropic drug within the past year.
  11. Need for medical or inpatient detoxification from alcohol. This determination will be made by the screening clinician, based on clinical judgement as in the multicenter STAR*D study (PHRC #2000-P-001955 in accordance with methods used in the multi-center STAR-D study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452543

Contacts
Contact: Janet M. Witte, MD, MPH 617-726-5104 jwitte@partners.org
Contact: Soo Jeong Youn, BA 617-724-2936 syoun@partners.org

Locations
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            
Sponsors and Collaborators
Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Janet M Witte, MD Massachusetts General Hospital
Principal Investigator: Nicholas Bolo, PhD Mclean Hospital
  More Information

No publications provided

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

Keywords provided by Massachusetts General Hospital:
Major depressive disorder
Alcoholism
Alcohol abuse
Alcohol dependence

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009