- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463111
Decision-Making in Bipolar Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30306
- Emory University Mood and Anxiety Disorders Program
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Mood stabilizer
Participants diagnosed with Bipolar Disorder will receive standard of care open-label treatment with a mood stabilizer for six weeks.
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Open label treatment per standard of care for bipolar disorder for six weeks.
Other Names:
Open label treatment per standard of care for bipolar disorder for six weeks.
Other Names:
Open label treatment per standard of care for bipolar disorder for six weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Time Frame: Baseline, Week 6
|
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.
|
Baseline, Week 6
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Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Time Frame: Baseline, Week 6
|
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.
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Baseline, Week 6
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Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Time Frame: Baseline, Week 6
|
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.
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Baseline, Week 6
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Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
Time Frame: Baseline, Week 6
|
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.
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Baseline, Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score
Time Frame: Baseline, Week 6
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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.
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Baseline, Week 6
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- GABA Agents
- Anticonvulsants
- Sodium Channel Blockers
- Antimanic Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
- Valproic Acid
Other Study ID Numbers
- IRB00050442
- BDDM (OTHER: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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