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Trial record 40 of 2553 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from the Emory Mood and Anxiety Disorders Program between August 2013 and December 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Participants With Major Depressive Disorder   Healthy Controls
STARTED   24   29 
COMPLETED   17   20 
NOT COMPLETED   7   9 
Lost to Follow-up                3                6 
Physician Decision                2                0 
Withdrawal by Subject                2                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who consented to take part in the study and fulfilled all eligibility criteria are included in the baseline analysis.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Participants With Major Depressive Disorder   Healthy Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   29   53 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.0  (11.3)   31.4  (9.6)   37.92  (12.57) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  66.7%      20  69.0%      36  67.9% 
Male      8  33.3%      9  31.0%      17  32.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   24   29   53 


  Outcome Measures

1.  Primary:   Money Earned   [ Time Frame: Baseline, Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: bdunlop@emory.edu



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