Trial Outcomes & Findings for Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism (NCT NCT00449007)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

6 months

Results posted on

2021-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Fluoxetine 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 fluoxetine: 6 months	Bupropion 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 bupropion: 6 months
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine n=2 Participants 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 fluoxetine: 6 months	Bupropion n=3 Participants 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 bupropion: 6 months	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	49.7 years STANDARD_DEVIATION 3.8 • n=5 Participants	33.5 years STANDARD_DEVIATION 10.6 • n=7 Participants	37.2 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: patients randomized to one of two arms for 6 months and assessed weekly for 8 weeks and then monthly

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

Outcome measures

Outcome measures
Measure	Fluoxetine for 6 Months n=2 Participants fluoxetine -- patients randomized to one of two arms for 6 months and assessed weekly for 8 weeks and then monthly. patients receive 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 fluoxetine: 6 months	Bupropion for 6 Months n=3 Participants bupropion fluoxetine -- patients randomized to one of two arms for 6 months and assessed weekly for 8 weeks and then monthly. patients receive 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 : bupropion: 6 months
Occurrence of Suicide Events Either a Suicide Death, a Suicide Attempt, or Suicidal Ideation Severe Enough to Warrant a Medical Intervention	2 suicide events	3 suicide events

SECONDARY outcome

Timeframe: 6 month

Population: All 5 participants had data and calculated scores for the Scale for Suicidal Ideation during the conduct of the trial.

Participant Score on the Scale for Suicidal Ideation will be the outcome variable. The SSI range is from 0-38 and higher score is worse and may predict suicide risk

Outcome measures

Outcome measures
Measure	Fluoxetine for 6 Months n=2 Participants fluoxetine -- patients randomized to one of two arms for 6 months and assessed weekly for 8 weeks and then monthly. patients receive 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 fluoxetine: 6 months	Bupropion for 6 Months n=3 Participants bupropion fluoxetine -- patients randomized to one of two arms for 6 months and assessed weekly for 8 weeks and then monthly. patients receive 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 : bupropion: 6 months
Suicidal Ideation at 6 Months	0.5 units on a scale Standard Deviation 0.7	8.5 units on a scale Standard Deviation 12.0

Adverse Events

Arm 1 Randomized to Fluoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 Randomized to Bupropion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria A. Oquendo, M.D., Ph.D.

Perelman School of Medicine, University of Pennsylvania

Phone: 215-662-2818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place