Trial Outcomes & Findings for Bupropion for Depression in ESRD Patients on Hemodialysis (NCT NCT02238977)

NCT ID: NCT02238977

Last Updated: 2018-07-17

Results Overview

Depression severity as measured by the 25-item Hamilton Depression Rating Scale. The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient/participant and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score the more severe the depression. The scale is scored by summing the total of all items. The maximum possible total score is 66 and the minimum is 0. A score \> 17 is considered compatible with a diagnosis of major depression. A score \< 10 is considered clinical remission. The interview and scoring takes about 15 minutes.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1 participants
• Primary outcome timeframe: up to 12 weeks
• Results posted on: 2018-07-17

Participant Flow

Participant milestones

Measure	Fluoxetine Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated. Fluoxetine: Antidepressant	Bupropion Bupropion sustained release (SR) 150 mg orally twice per week Bupropion: Antidepressant
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion for Depression in ESRD Patients on Hemodialysis

Baseline characteristics by cohort

Measure	Fluoxetine Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated. Fluoxetine: Antidepressant	Bupropion n=1 Participants Bupropion sustained release (SR) 150 mg orally twice per week Bupropion: Antidepressant	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 12 weeks

Population: Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.

Depression severity as measured by the 25-item Hamilton Depression Rating Scale. The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient/participant and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score the more severe the depression. The scale is scored by summing the total of all items. The maximum possible total score is 66 and the minimum is 0. A score > 17 is considered compatible with a diagnosis of major depression. A score < 10 is considered clinical remission.

The interview and scoring takes about 15 minutes.

Outcome measures

Measure	Bupropion n=1 Participants Bupropion sustained release (SR) 150 mg orally twice per week Bupropion: Antidepressant	Fluoxetine Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated. Fluoxetine: Antidepressant
Depression Severity	18 units on a scale	—

Adverse Events

Fluoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupropion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pedro Delgado, M.D.

University of Arkansas for Medical Sciences

Phone: 501-526-8100

Email: pldelgado@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place