N/A
N=26
Decision-Making in Bipolar Disorder
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01463111 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ) — .176 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lithium (Drug); Valproate (Drug); Lamotrigine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ) |
.176 | — |
| PRIMARY Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ) |
-3.41 | — |
| PRIMARY Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ) |
-2.23 | — |
| PRIMARY Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ) |
2.47 | — |
| SECONDARY Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score |
-3.941; -4.063; -2.625 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female, age 18-65
- Primary DSM-IV TR Diagnosis of Bipolar Disorder, type I, II or NOS.
- Ability to visually read and understand English language
- Not currently taking any mood stabilizer or antipsychotic medication.
- Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.
Exclusion Criteria
- Meet criteria for substance abuse or dependence within three months of the screening visit.
- Presents with a clinically significant suicide risk, as assessed by a study physician.
- Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
- Women who are currently pregnant or lactating, or plan to become pregnant during the study.
Data sourced from ClinicalTrials.gov (NCT01463111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.