Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
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.
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.
Inclusion Criteria:

 1. DSM-IV diagnostic criteria for MDD (diagnosis based on Structured Clinical Interview
 for DSM-IV, Patient Edition; 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.