Effects of Treatment on Decision-making in Major Depression
Condition: Major Depressive Disorder; Healthy Controls
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Any FDA Approved Antidepressant
Intervention description: 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.
Intervention MeSH terms: Duloxetine Hydrochloride; Mirtazapine; Citalopram; Bupropion; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Antidepressive Agents; Desvenlafaxine Succinate; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: depression; melancholia; treatment

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.
    

Eligibility 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.