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Decision-Making in Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lithium
Valproate
Lamotrigine
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bipolar Disorder focused on measuring Bipolar, Manic depression, Mood stabilizer, Decision, Neuroeconomics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female, age 18-65
  2. Primary DSM-IV TR Diagnosis of Bipolar Disorder, type I, II or NOS.
  3. Ability to visually read and understand English language
  4. Not currently taking any mood stabilizer or antipsychotic medication.
  5. Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.

Exclusion Criteria:

  1. Meet criteria for substance abuse or dependence within three months of the screening visit.
  2. Presents with a clinically significant suicide risk, as assessed by a study physician.
  3. Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
  4. Women who are currently pregnant or lactating, or plan to become pregnant during the study.

Sites / Locations

  • Emory University Mood and Anxiety Disorders Program

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mood stabilizer

Arm Description

Participants diagnosed with Bipolar Disorder will receive standard of care open-label treatment with a mood stabilizer for six weeks.

Outcomes

Primary Outcome Measures

Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
The MDMQ is a 22-item self report form assessing four different styles of decision making. Vigilance is considered the healthy, adaptive, decision-making style, reflecting consideration of an array of outcomes and ultimately rational decision-making. Scores range from 0-12. A higher score indicates that vigilance is used more frequently during decision making. A higher score indicates healthier decision making.
Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
The MDMQ is a 22-item self report form assessing four different styles of decision making. Hypervigilance is marked by hurried, anxious decision-making. Scores range from 0-10. A higher score indicates a "worse" score and that a hyper-vigilant decision making style is used more frequently.
Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
The MDMQ is a 22-item self report form assessing four different styles of decision making. The buckpassing decision-making style represents a tendency to leave decisions to others. Scores range from 0-12. A higher score indicates that the buckpassing decision-making style is used more frequently and represents a "worse" score.
Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
The MDMQ is a 22-item self report form assessing four different styles of decision making. The procrastination decision-making style involves putting off making decisions. Scores range from 0-10. A higher score indicates that the procrastination decision-making style is used more and is considered a "worse" score.

Secondary Outcome Measures

Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score
The BIS-11 is a 30 item self-report questionnaire, used to assess three factors of impulsivity: 1). attentional impulsiveness, reflecting a difficulty concentrating or tolerating cognitive complexity, 2). motor impulsiveness, reflecting a tendency to act before thinking, and 3). non-planing impulsiveness, reflecting a lack of forethought about potential consequences. Items are scored on a 4-point scale: Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4. Attentional impulsivity scores range from 8-32. Motor impulsivity scores range from 11-44. Non-planning impulsivity scores range from 11-44. Total BIS-11 scores range from 30-120. A higher score reflects higher impulsivity across all sub-types.

Full Information

First Posted
June 2, 2011
Last Updated
May 2, 2017
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01463111
Brief Title
Decision-Making in Bipolar Disorder
Official Title
Decision-Making in Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar, Manic depression, Mood stabilizer, Decision, Neuroeconomics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mood stabilizer
Arm Type
Other
Arm Description
Participants diagnosed with Bipolar Disorder will receive standard of care open-label treatment with a mood stabilizer for six weeks.
Intervention Type
Drug
Intervention Name(s)
Lithium
Other Intervention Name(s)
Eskalith
Intervention Description
Open label treatment per standard of care for bipolar disorder for six weeks.
Intervention Type
Drug
Intervention Name(s)
Valproate
Other Intervention Name(s)
Valproic Acid, Depakote
Intervention Description
Open label treatment per standard of care for bipolar disorder for six weeks.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Other Intervention Name(s)
Lamictal
Intervention Description
Open label treatment per standard of care for bipolar disorder for six weeks.
Primary Outcome Measure Information:
Title
Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Description
The MDMQ is a 22-item self report form assessing four different styles of decision making. Vigilance is considered the healthy, adaptive, decision-making style, reflecting consideration of an array of outcomes and ultimately rational decision-making. Scores range from 0-12. A higher score indicates that vigilance is used more frequently during decision making. A higher score indicates healthier decision making.
Time Frame
Baseline, Week 6
Title
Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Description
The MDMQ is a 22-item self report form assessing four different styles of decision making. Hypervigilance is marked by hurried, anxious decision-making. Scores range from 0-10. A higher score indicates a "worse" score and that a hyper-vigilant decision making style is used more frequently.
Time Frame
Baseline, Week 6
Title
Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Description
The MDMQ is a 22-item self report form assessing four different styles of decision making. The buckpassing decision-making style represents a tendency to leave decisions to others. Scores range from 0-12. A higher score indicates that the buckpassing decision-making style is used more frequently and represents a "worse" score.
Time Frame
Baseline, Week 6
Title
Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Description
The MDMQ is a 22-item self report form assessing four different styles of decision making. The procrastination decision-making style involves putting off making decisions. Scores range from 0-10. A higher score indicates that the procrastination decision-making style is used more and is considered a "worse" score.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score
Description
The BIS-11 is a 30 item self-report questionnaire, used to assess three factors of impulsivity: 1). attentional impulsiveness, reflecting a difficulty concentrating or tolerating cognitive complexity, 2). motor impulsiveness, reflecting a tendency to act before thinking, and 3). non-planing impulsiveness, reflecting a lack of forethought about potential consequences. Items are scored on a 4-point scale: Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4. Attentional impulsivity scores range from 8-32. Motor impulsivity scores range from 11-44. Non-planning impulsivity scores range from 11-44. Total BIS-11 scores range from 30-120. A higher score reflects higher impulsivity across all sub-types.
Time Frame
Baseline, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boadie W Dunlop, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Mood and Anxiety Disorders Program
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States

12. IPD Sharing Statement

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Decision-Making in Bipolar Disorder

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