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Trial record 40 of 2592 for:    depression AND Major Depression | "Depression"

Effects of Treatment on Decision-making in Major Depression

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ClinicalTrials.gov Identifier: NCT01916824
Recruitment Status : Completed
First Posted : August 6, 2013
Results First Posted : October 20, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Major Depressive Disorder
Healthy Controls
Intervention Drug: Any FDA Approved Antidepressant
Enrollment 53
Recruitment Details Participants were enrolled from the Emory Mood and Anxiety Disorders Program between August 2013 and December 2015.
Pre-assignment Details 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.
Arm/Group Title Participants With Major Depressive Disorder Healthy Controls
Hide Arm/Group Description Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
Period Title: Overall Study
Started 24 29
Completed 17 20
Not Completed 7 9
Reason Not Completed
Lost to Follow-up             3             6
Physician Decision             2             0
Withdrawal by Subject             2             3
Arm/Group Title Participants With Major Depressive Disorder Healthy Controls Total
Hide Arm/Group Description Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness Total of all reporting groups
Overall Number of Baseline Participants 24 29 53
Hide Baseline Analysis Population Description
All participants who consented to take part in the study and fulfilled all eligibility criteria are included in the baseline analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 29 participants 53 participants
46.0  (11.3) 31.4  (9.6) 37.92  (12.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 29 participants 53 participants
Female
16
  66.7%
20
  69.0%
36
  67.9%
Male
8
  33.3%
9
  31.0%
17
  32.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 29 participants 53 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.2%
1
   3.4%
2
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  29.2%
13
  44.8%
20
  37.7%
White
15
  62.5%
14
  48.3%
29
  54.7%
More than one race
1
   4.2%
1
   3.4%
2
   3.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants 29 participants 53 participants
24
 100.0%
29
 100.0%
53
 100.0%
1.Primary Outcome
Title Money Earned
Hide Description

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
Time Frame Baseline, Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population at each time point includes the number of participants completing the each visit.
Arm/Group Title Participants With Major Depressive Disorder Healthy Controls
Hide Arm/Group Description:
Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: US Dollars
Baseline Visit Number Analyzed 24 participants 29 participants
23.2  (5.6) 25.0  (5.6)
After 6 Weeks of Treatment Number Analyzed 17 participants 20 participants
20.5  (6.6) 21.9  (5.3)
Time Frame Adverse events were collected from the time each participant provided informed consent throughout the entire 6 week duration of study participation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants With Major Depressive Disorder Healthy Controls
Hide Arm/Group Description Persons with a primary diagnosis of Major Depressive Disorder who start taking any FDA-approved antidepressant prescribed within standard dose range for 6 weeks Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness
All-Cause Mortality
Participants With Major Depressive Disorder Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Major Depressive Disorder Healthy Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Major Depressive Disorder Healthy Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/24 (50.00%)      2/29 (6.90%)    
Gastrointestinal disorders     
Diarrhea *  2/24 (8.33%)  2 0/29 (0.00%)  0
General disorders     
Headache *  5/24 (20.83%)  5 2/29 (6.90%)  2
Insomnia *  4/24 (16.67%)  4 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Tract Infection *  3/24 (12.50%)  3 2/29 (6.90%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Boadie Dunlop, MD
Organization: Emory University
Phone: 404-727-8969
Responsible Party: Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier: NCT01916824     History of Changes
Other Study ID Numbers: IRB00066705
First Submitted: August 3, 2013
First Posted: August 6, 2013
Results First Submitted: September 20, 2017
Results First Posted: October 20, 2017
Last Update Posted: November 21, 2017