Trial Outcomes & Findings for Effects of Treatment on Decision-making in Major Depression (NCT NCT01916824)
NCT ID: NCT01916824
Last Updated: 2017-11-21
Results Overview
Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical "points" that do not have meaning in the real world. Greater earnings indicate better financial decision-making. The specific tasks were: 1. risk task 2. balloon analogue risk task 3. temporal discounting task 4. ultimatum game 5. continuous performance task
COMPLETED
PHASE4
53 participants
Baseline, Week 6
2017-11-21
Participant Flow
Participants were enrolled from the Emory Mood and Anxiety Disorders Program between August 2013 and December 2015.
A total of 55 individuals gave informed consent to participate in the study. Of these, 2 were screen failures, resulting in 53 who began the trial.
Participant milestones
| Measure |
Participants With Major Depressive Disorder
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
|
Healthy Controls
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
29
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Participants With Major Depressive Disorder
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
|
Healthy Controls
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Effects of Treatment on Decision-making in Major Depression
Baseline characteristics by cohort
| Measure |
Participants With Major Depressive Disorder
n=24 Participants
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
|
Healthy Controls
n=29 Participants
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
37.92 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: The population at each time point includes the number of participants completing the each visit.
Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical "points" that do not have meaning in the real world. Greater earnings indicate better financial decision-making. The specific tasks were: 1. risk task 2. balloon analogue risk task 3. temporal discounting task 4. ultimatum game 5. continuous performance task
Outcome measures
| Measure |
Participants With Major Depressive Disorder
n=24 Participants
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
|
Healthy Controls
n=29 Participants
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
|
|---|---|---|
|
Money Earned
Baseline Visit
|
23.2 US Dollars
Standard Deviation 5.6
|
25.0 US Dollars
Standard Deviation 5.6
|
|
Money Earned
After 6 Weeks of Treatment
|
20.5 US Dollars
Standard Deviation 6.6
|
21.9 US Dollars
Standard Deviation 5.3
|
Adverse Events
Participants With Major Depressive Disorder
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Major Depressive Disorder
n=24 participants at risk
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
|
Healthy Controls
n=29 participants at risk
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
|
|---|---|---|
|
General disorders
Headache
|
20.8%
5/24 • Number of events 5 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
|
General disorders
Insomnia
|
16.7%
4/24 • Number of events 4 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
0.00%
0/29 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
12.5%
3/24 • Number of events 3 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
0.00%
0/29 • Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place