Effects of Treatment on Decision-making in Major Depression

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Antidepressive Agents; Bupropion; Citalopram; Desvenlafaxine Succinate; Duloxetine Hydrochloride; Fluoxetine; Mirtazapine; Paroxetine; Sertraline; Venlafaxine Hydrochloride

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.