Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism
Condition: Depression; Alcoholism; Suicidal Behavior
MeSH terms: Alcoholism; Depression; Depressive Disorder
Intervention: fluoxetine; bupropion
Intervention description: 6 months; 6 months
Intervention MeSH terms: Bupropion; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Alcohol abuse; Alcohol dependence; Suicide

Summary:

      We will study patients with a current major depressive episode, comorbid alcoholism and a
      history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for
      risk of alcohol withdrawal prior to randomization. The study will provide six months of
      antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse
      prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings.
      The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal
      ideation; 3) reduction in neuropsychological measures of impulsivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient suffering from a major depressive episode (unipolar only) AND alcohol
             dependence or abuse; Score of greater than 16 on the HDRS

          -  Age range 18-65 years

          -  History of a past suicide attempt, defined as self destructive behavior with at least
             some intent to die; patients with suicidal plan or intent will only be enrolled as
             inpatients if staff agrees it is reasonable.

          -  Able to tolerate cross taper to study medications

        Exclusion Criteria:

          -  Other major psychiatric disorders such as Bipolar Disorder; schizophrenia or
             schizoaffective disorder, past or current psychotic symptoms; eating disorder;
             substance abuse or dependence (other than alcohol, caffeine or nicotine); persons
             already taking SSRIs or bupropion for other indications such as anxiety disorders.

          -  Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/Social anxiety
             disorder, with secondary depression.

          -  CIWA-AR rating >10 or history of delirium tremens or seizures.

          -  Blood pressure >150 systolic or >90 diastolic

          -  Active or untreated medical problems

          -  Antipsychotic medication required

          -  History of becoming hypomanic or manic on antidepressants

          -  Contraindication to the use of fluoxetine or bupropion, or currently using Zyban

          -  Failure to respond to adequate trials of 3 SSRIs or fluoxetine or bupropion in the
             last 2 years (failure to respond to therapeutic trial defined as: at least 2/3 maximal
             PDR dose for at least 6 weeks)

          -  Lack of capacity to consent

          -  Pregnancy, lactation, or plans to conceive during the course of study participation