Effects of Treatment on Decision-making in Major Depression
Condition: Major Depressive Disorder; Healthy Controls
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      During episodes of depression patients with major depressive disorder (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. The specific tasks are:

        1. Risk Task - This task assesses tolerance of risk by having participants decide whether
           they wish to accept a specific dollar payout, or to play a lottery with an uncertain
           payout.

        2. Balloon Analogue Risk Task - The participant is presented with a balloon and offered the
           chance to earn money by pumping the balloon up by clicking a button. Each click causes
           the balloon to incrementally inflate and money to be added to a counter up until some
           threshold, at which point the balloon is over inflated and explodes. Thus, each pump
           confers greater risk but also greater potential reward. If the participant chooses to
           cash-out prior to the balloon exploding then they collect the money earned for that
           trial, but if balloon explodes earnings for that trial are lost. Participants are not
           informed about the balloons breakpoints; the absence of this information allows for
           testing both participants' initial responses to the task and changes in responding as
           they gain experience with the task contingencies.

        3. Temporal Discounting Task - Participants are initially asked to choose between taking an
           immediate reward now or a larger reward at some time in the future. Decisions for seven
           time points over a 10-year time frame are proposed. The task is then repeated using
           choices between immediate and delayed losses, based on the same seven time points. This
           task assesses the manner in which subjects value immediate outcomes compared to
           long-term consequences.

        4. Ultimatum Game - The ultimatum game (UG) is a well-established game-theoretical paradigm
           commonly employed in behavioral economics to measure emotional reactions to unfair
           offers. In the UG, two subjects sequentially exchange real monetary amounts.
           Specifically, a proposer is provided with a sum of money by the experimenter ($10), and
           asked to share this amount of money with another player, the responder. The responder
           then decides whether to accept or reject the offer made by the proposer. If the
           responder accepts the offer, both players receive the respective amounts from the
           proposer's offer. If she rejects the offer made by the proposer, both players receive
           nothing ($0). This is best illustrated via the following two potential scenarios: 1. the
           proposer offers a fair split of $5 for himself and $5 for the responder. This is an
           offer that is typically accepted by a great majority of responders. 2. The proposer
           offers a split of $9 for himself and $1 for the responder. Such offers are commonly
           rejected by the majority of responders, despite incurring a financial loss of $1.

        5. Continuous Performance Task - This task involves identifying patterns of numbers briefly
           displayed on a computer screen. This task will serve as a control variable for attention
           in analyzing the results of the decision-making tasks.
    

Intervention name(s): Any FDA Approved Antidepressant
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Sertraline, Zoloft; Citalopram, Celexa; Escitalopram, Lexapro; Paroxetine, Paxil; Fluoxetine, Prozac; Vilazodone, Viibryd; Venlafaxine XR, Effexor XR; Desvenlafaxine, Pristiq; Duloxetine, Cymbalta; Bupropion, Wellbutrin; Mirtazapine, Remeron
Intervention MeSH terms: Duloxetine Hydrochloride; Mirtazapine; Citalopram; Bupropion; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Antidepressive Agents; Desvenlafaxine Succinate; Escitalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: depression; melancholia; treatment