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Trial record 3 of 133 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

Bupropion for Depression in ESRD Patients on Hemodialysis

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ClinicalTrials.gov Identifier: NCT02238977
Recruitment Status : Terminated (Study stopped due to difficulty recruiting)
First Posted : September 12, 2014
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depression
End Stage Renal Disease
Interventions Drug: Fluoxetine
Drug: Bupropion
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluoxetine Bupropion
Hide Arm/Group Description

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 sustained release (SR) 150 mg orally twice per week

Bupropion: Antidepressant

Period Title: Overall Study
Started 0 1
Completed 0 1
Not Completed 0 0
Arm/Group Title Fluoxetine Bupropion Total
Hide Arm/Group Description

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 sustained release (SR) 150 mg orally twice per week

Bupropion: Antidepressant

Total of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
Due to inability to recruit subjects study was terminated. Only one subject enrolled and completed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
>=65 years
1
 100.0%
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
American Indian or Alaska Native 0
0
   0.0%
0
   0.0%
Asian 0
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander 0
0
   0.0%
0
   0.0%
Black or African American 0
1
 100.0%
1
 100.0%
White 0
0
   0.0%
0
   0.0%
More than one race 0
0
   0.0%
0
   0.0%
Unknown or Not Reported 0
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Depression Severity
Hide Description

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.

Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.
Arm/Group Title Bupropion Fluoxetine
Hide Arm/Group Description:

Bupropion sustained release (SR) 150 mg orally twice per week

Bupropion: Antidepressant

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

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: units on a scale
18
Time Frame Up to 12 weeks
Adverse Event Reporting Description Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.
 
Arm/Group Title Fluoxetine Bupropion
Hide Arm/Group Description

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 sustained release (SR) 150 mg orally twice per week

Bupropion: Antidepressant

All-Cause Mortality
Fluoxetine Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   1/1 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fluoxetine Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluoxetine Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Pedro Delgado, M.D.
Organization: University of Arkansas for Medical Sciences
Phone: 501-526-8100
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02238977     History of Changes
Other Study ID Numbers: 203076
R21DK097470 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2014
First Posted: September 12, 2014
Results First Submitted: April 2, 2018
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018