Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism

NCT00449007 | Terminated Phase 4 Results DMC

• 3 other identifiers: NIAAA-OQU-015630-02P20AA015630NIH Grant P20 AA015630-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Alcoholism; Suicidal Behavior

Keywords

Major depressive disorder; Alcohol abuse; Alcohol dependence; Suicide

Outcome Measures

Primary Outcomes (1)

• Occurrence of Suicide Events Either a Suicide Death, a Suicide Attempt, or Suicidal Ideation Severe Enough to Warrant a Medical Intervention

  patients have either a suicide death, a suicide attempt, or suicidal ideation severe enough to warrant a medical intervention. this is assessed using the Columbia Suicide History Form and a consensus conference rules on whether the event meets criteria or not. Medical interventions can include hospitalization, a change in medication (adding adjunctive meds) or an increase in frequency of visits or other methods to monitor the patient. The range is 0 and up and denotes the number of suicide events (not the number of participants and not the number of suicide attempts). Higher score is worse and predicts future suicidal behavior

  6 months

Secondary Outcomes (1)

• Suicidal Ideation at 6 Months

  6 month

Study Arms (2)

1

ACTIVE COMPARATOR

fluoxetine -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings

Drug: fluoxetine

2

ACTIVE COMPARATOR

bupropion -- 6 months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention; patients will also be encouraged to attend daily Alcoholics Anonymous meetings

Drug: bupropion

Interventions

fluoxetine DRUG

6 months

1

bupropion DRUG

6 months

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Alcoholism; Depressive Disorder, Major; Suicide

Interventions

Fluoxetine; Bupropion

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Propiophenones; Ketones

Results Point of Contact

• Title: Maria A. Oquendo, M.D., Ph.D.
• Organization: Perelman School of Medicine, University of Pennsylvania

moquendo@pennmedicine.upenn.edu

215-662-2818

Study Officials

• Maria A. Oquendo, MD

  NYS Psychiatric Institute / Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: February 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 4, 2021
• Results First Posted: July 16, 2021

Record last verified: 2021-07

Locations

US (1)