Overview

This trial is active, not recruiting.

Conditions major depressive disorder, healthy controls
Treatment antidepressant
Phase phase 4
Sponsor Emory University
Start date August 2013
End date August 2017
Trial size 100 participants
Trial identifier NCT01916824, IRB00066705

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Arm
(Other)
Any FDA-approved antidepressant prescribed within standard dose range for 6 weeks.
antidepressant Sertraline, Zoloft

Primary Outcomes

Measure
Money earned
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 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.

Additional Information

Official title Effects of Treatment on Decision-making in Major Depression
Principal investigator Boadie W Dunlop, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Emory University.