Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA); New York State Psychiatric Institute
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Bupropion; Ethanol; Fluoxetine

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