Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
Condition: Major Depressive Disorder; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: acamprosate; escitalopram; Medical management; Placebo
Intervention description: Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.; Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.; Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).; Placebo, 2 capsules PO TID, for 12 weeks
Intervention MeSH terms: Acamprosate; Dexetimide; Citalopram; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Alcoholism; Alcohol abuse; Alcohol dependence

Summary:

      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.
    

Eligibility criteria:

        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.