Please select the eligibility criteria that correspond to the clinical trial below.
Title: Naltrexone & SSRI in Alcoholics With Depression/PTSD
Brief Summary: The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.

We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.


Options:
A: Inclusion Criteria:

* Adults
* Clinical diagnosis of major depressive disorder (DSM-IV)
* HDRS-17 items \> 20
* Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)

Exclusion Criteria:

* I or II bipolar disorder
* Psychotic features
* Failure of one previous venlafaxine treatment
* Addiction comorbidity or schizophrenia comorbidity
* Involuntary hospitalization
* Seizures history
* Pregnancy or breastfeeding
* Somatic comorbidity able to impact on cognitive functions
B: Inclusion Criteria:

* Male and female outpatients 18 75 years of age.
* Patients must have met DSM-IV criteria for (primary or substance-induced) major depressive episode prior to randomization.
* Patients must have a current DSM-IV diagnosis of alcohol dependence.
* Patients must have a total score of 10 or higher on the Hamilton Depression Scaleat the day of randomization. Also, item 1 on the scale must be \> 1.
* Patients must have drank sufficient alcohol in the month prior to coming for treatment so that a practical assessment in reductions in drinking during and after treatment can be performed. The guidelines we will follow for this study as to what we think is sufficient will be that the patient in the month prior to coming to treatment will have drank on 40% or more of the days or drank more than 40 standard drinks (an average of 10 drinks per week).
* Patients must have successfully completed medical detoxification for alcohol (are abstinent for 4 consecutive days) or if medical detoxification is not indicated, have been abstinent for 4 consecutive days since coming to treatment but before initiating the study medication/placebo.
* Females of childbearing potential must have a negative pregnancy test and not contemplating pregnancy within the next 6 months. They must also use a contraceptive method judged by the investigator to be effective.

Exclusion Criteria:

* Patients with evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screens (only one repeat testing permitted). Patients with a history of treatment for opiate dependence will be excluded.
* Patients who, within the past year, met DSM IV criteria for dependence on any psychoactive substance other than alcohol or nicotine. Patients who test positive on the urine drug screen (with the exception of THC) at the initial visit (only one repeat testing permitted).
* Patients who meet DSM-IV criteria for past history or current disorder of schizophrenia or any psychotic disorder, or bipolar disorder.
* Patients with evidence or history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease. (If there is a history of such disease but the condition has been stable for more than one year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.)
* Patients with abnormal liver function tests (AST or ALT) (more than 3.5 times the upper level of the normal value) or patients with any abnormal elevation in bilirubin.
* Patients requiring concomitant therapy with any psychotropic drug (with the exception of benadryl used sparingly if necessary for sleep or oxeazepam for detoxification or nicotine replacement therapy).
* Patients who have taken fluoxetine (Prozac) during the 6 weeks prior to randomization --due to its long half-life.
* Patients who have taken monoamine oxidase inhibitors (MAOI) during the 2 weeks prior to randomization -- due to the potential toxicity of combining MAOI medications with serotonin-specific ones. (Patients will also be instructed not to take MAOI for 2 weeks after completing the study.)
* Past use of antidepressants or other psychotropic medications (except as specified above) within 7 days of randomization.
* Patients on concomitant therapy with an investigational drug, or patients who have been in an investigational drug study within one month prior to entering this study.
* Patients who are unable to read or print in English.
C: 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.
D: 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

Answer: D