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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

Brief Summary:
In this trial, fifty participants with current major depressive disorder who are not receiving an antidepressant medication and fifty healthy controls will complete questionnaires and computerized tasks to assess their decision-making styles. There will be three visits for depressed patients and two for healthy controls (the first and third visits). The first visit will involve interviews and questionnaires to assess the participant's level of depression, medical history and quality of life. Participants will then complete the decision-making tasks, and will earn between $5-40 based on their choices, in order to make the decisions on the computer tasks financially meaningful. At the completion of this visit, depressed patients will be prescribed an FDA-approved antidepressant, chosen in consultation with the treating psychiatrist. Patients will be responsible for paying for the prescription themselves. After two weeks on the medication, the patient will be seen for a follow-up visit to ensure tolerability of the medicine. After six weeks on the medicine, patients and healthy controls will return to repeat the questionnaires and the computer based decision-making tasks, and will again earn between $5-40 based on their performance.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Healthy Controls Drug: Any FDA Approved Antidepressant Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Treatment on Decision-making in Major Depression
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: 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
Drug: Any FDA Approved Antidepressant
Any FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks. Psychiatric follow-up will be performed during the study participation. At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances.
Other Names:
  • Sertraline, Zoloft
  • Citalopram, Celexa
  • Escitalopram, Lexapro
  • Paroxetine, Paxil
  • Fluoxetine, Prozac
  • Vilazodone, Viibryd
  • Venlafaxine XR, Effexor XR
  • Desvenlafaxine, Pristiq
  • Duloxetine, Cymbalta
  • Bupropion, Wellbutrin
  • Mirtazapine, Remeron

No Intervention: Healthy Controls
Persons without a history of Major Depressive Disorder and without a current diagnosis of any mental illness



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

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for MDD Subjects:

  1. Male or female, age 18-65
  2. Primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) Diagnosis of Major Depressive Disorder.
  3. Has a 17-item Hamilton depression rating scale (HDRS-17) score >=16.
  4. Ability to visually read and understand English language
  5. Not currently taking an antidepressant.
  6. Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.

Inclusion Criteria for Healthy Control Subjects:

  1. Male or female, age 18-65
  2. No current DSM-IV TR diagnosis of a mental illness.
  3. No lifetime history of Major Depressive Disorder or Dysthymia.
  4. Has a 17-item Hamilton depression rating scale (HDRS-17) score ≤7.
  5. Ability to visually read and understand English language
  6. Not currently taking any psychoactive medication

Exclusion Criteria for all subjects:

  1. Has met criteria at any time during their life for bipolar disorder, a primary psychotic disorder (e.g. schizophrenia), or dementia.
  2. Meet criteria for substance abuse or dependence within three months of the screening visit.
  3. Presents with a clinically significant suicide risk, as assessed by a study physician.
  4. Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
  5. Women who are currently pregnant or lactating, or plan to become pregnant during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916824


Locations
United States, Georgia
Emory Mood and Anxiety Disorders Program
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Boadie W Dunlop, MD Emory University

Additional Information:
Responsible Party: Boadie W. Dunlop, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01916824     History of Changes
Other Study ID Numbers: IRB00066705
First Posted: August 6, 2013    Key Record Dates
Results First Posted: October 20, 2017
Last Update Posted: November 21, 2017
Last Verified: October 2017

Keywords provided by Boadie W. Dunlop, Emory University:
depression
melancholia
treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs