Effects of Treatment on Decision-making in Major Depression
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Healthy Controls
Intervention: Antidepressant (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Emory University Official(s) and/or principal investigator(s): Boadie W Dunlop, MD, Principal Investigator, Affiliation: Emory University
Summary
During episodes of depression patients with MDD may make sub-optimal decisions based on
exaggerated negative beliefs about themselves, the future, or the world around them. These
disruptions in decision-making contribute adversely to quality of life, in both work and
personal realms. Although effective treatments for depression are available, very little
work has explored the effects of treatment on how people make decisions. The specific
aspects of decision-making that differ between depressed and health control individuals are
unknown, and whether any changes in these decision-making features occur as a result of
improvement from depression, or whether medication treatment itself can lead to changes in
decision-making, even in the absence of clinical improvement.
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.
The overall goal of this study will be to identify whether decision-making characteristics
in people with major depression is affected by treatment, and whether depressed patients
make decisions differently from healthy controls. A total of 4 decision-making tasks and one
control task will be administered via computer to eligible subjects.
Clinical Details
Official title: Effects of Treatment on Decision-making in Major Depression
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Money earned
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria for MDD Subjects:
1. Male or female, age 18-65
2. Primary 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
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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.
Locations and Contacts
Emory Mood and Anxiety Disorders Program, Atlanta, Georgia 30322, United States
Additional Information
Emory Mood and Anxiety Disorders Program home page
Starting date: August 2013
Last updated: July 2, 2015
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