Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief 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.


Options:
A: Inclusion Criteria:

1. The subject/patient is able to read and understand the subject/patient information sheet.
2. Prior to any screening procedures, the subject/patient must have signed the informed consent form. No study-related procedures may be performed before the subject/patient has signed the form.
3. Age 25-70 years
4. Heavy alcohol consumption (males more than 5 doses/ day, female more than 4 doses/day) for at least 10 years
5. Alcohol dependence (DSM-IV) assessed by SCID-I interview.
6. Major depression (DSM-IV) assessed by SCID-I interview. At least 4 weeks past from the previous inpatient treatment for AWS (alcohol withdrawal syndrome).

Exclusion Criteria:

1. Other drug dependence (screened by urine test)
2. Other serious mental illness (DSM-IV)
3. Hazard of suicide
4. Pregnancy
5. Serious kidney, hart or thyroid problem
6. The subject/patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
7. Liver cirrhosis or liver enzymes ASAT tai ALAT \>200.
8. The person that met the criteria stated in the Finnish Law on Clinical Studies, paragraph 7-10§ (children, pregnant, imamates or mentally handicapped).
B: Inclusion Criteria:

* Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
* 18-65 years of age
* Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
* Able to read English and complete study evaluations
* Male, or if female, without active reproductive potential
* Participants will have signed informed consent

Exclusion Criteria:

* Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
* Regular use of psychoactive drugs including anxiolytics and antidepressants
* Current use of disulfiram or naltrexone
* Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
* Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject
C: Inclusion Criteria:

* DSM-IV diagnosis of alcohol dependence and current DSM-IV depressive disorder or PTSD
* a recent episode of heavy drinking
* outpatient, sober from alcohol and other abused substance for at least 2 days before randomization
* stable medication regiment for at least 2 weeks
* women on adequate methods of contraception

Exclusion Criteria:

* current opioid dependence or abuse
* history (within the last 3 months) of opioid dependence or abuse
* pregnant
* history of psychotic disorders or current treatment with antipsychotic medications
* medication thought to influence drinking including: acamprosate, disulfiram, naltrexone, ondansetron, valproic acid or tegretol
* current (within the lst 6 months) use of MAO inhibitors
* suicidal active ideation or intent
* significant underlying medical condition
* history of cardiac condition abnormalities
D: 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.

Answer: D