Decision-Making in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Forty subjects with bipolar disorder who are not receiving a mood-stabilizing medication for
      the treatment of their illness will participate in this study. The study aims to evaluate how
      decision-making is affected by treatment for bipolar disorder. Prior to beginning treatment,
      patients will complete questionnaires and a one-hour computer-administered assessment of
      decision-making. Differences between pre-post decision-making outcomes will be evaluated to
      examine whether the neuroeconomic concepts of risk aversion, loss aversion, risk tolerance
      and delay discounting are affected by treatment.

      The overall goal of this study will be to identify whether decision-making in people with
      bipolar disorder is affected by treatment. Specifically the investigators will compare
      decision-making characteristics among bipolar patients prior to treatment with how these
      decision-making characteristics change over the course of 6 weeks of standard medication
      therapy for bipolar disorder. A total of 6 decision-making tasks and one control task will be
      administered via computer to eligible subjects. The investigators will evaluate
      decision-making under varying conditions of reward, risk, and uncertainty and over time. The
      investigators hypothesize that decision-making will improve across these assessments after 6
      weeks of treatment.
    

Detailed description: 
      Participation in this study will require three study visits over 6 weeks. Subjects will be
      evaluated with the Structured Diagnostic Interview for DSM-IV to confirm diagnosis. They will
      also be administered the Hamilton Anxiety and Depression Rating Scales. Eligible subjects
      will then complete questionnaires related to their symptoms as well as decision-making and
      risk-taking, including: the Barratt Impulsiveness Scale, the Spielberger State-Trait Anxiety
      Inventory, and the Flinders Decision-making questionnaire. The Montgomery-Asburg Depression
      Severity scale to assess changes in depression symptom severity and the Young Mania Rating
      Scale to assess changes in manic symptom severity, will be conducted at screening, baseline,
      and endpoint. Patients will also be given the Childhood Trauma Questionnaire at baseline
      visit, to assess for a history of childhood trauma. The subjects will then complete the
      computer-generated decision-making tasks. Upon completion, the study physician will initiate
      standard-of-care treatment with a mood stabilizer (either lithium, valproate, or
      lamotrigine). Standard-of-care laboratory testing and psychiatric follow-up will be performed
      during the patient's study participation. After six weeks of treatment with a mood
      stabilizer, patients will again complete the decision-making computerized assessment.
    

Intervention name(s): Lithium; Valproate; Lamotrigine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Open label treatment per standard of care for bipolar disorder for six weeks.; Open label treatment per standard of care for bipolar disorder for six weeks.; Open label treatment per standard of care for bipolar disorder for six weeks.
Other intervention name(s): Eskalith; Valproic Acid; Depakote; Lamictal
Intervention MeSH terms: Lamotrigine; Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bipolar; Manic depression; Mood stabilizer; Decision; Neuroeconomics