Decision-Making in Bipolar Disorder

NCT01463111 | Completed Results DMC

• 2 other identifiers: IRB00050442BDDM
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar; Manic depression; Mood stabilizer; Decision; Neuroeconomics

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline, Week 6

• 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.

  Baseline, Week 6

• 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.

  Baseline, Week 6

• 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.

  Baseline, Week 6

Secondary Outcomes (1)

• Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score

  Baseline, Week 6

Study Arms (1)

Mood stabilizer

OTHER

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

Drug: Lithium; Drug: Valproate; Drug: Lamotrigine

Interventions

Lithium DRUG

Open label treatment per standard of care for bipolar disorder for six weeks.

Also known as: Eskalith

Mood stabilizer

Valproate DRUG

Open label treatment per standard of care for bipolar disorder for six weeks.

Also known as: Valproic Acid, Depakote

Mood stabilizer

Lamotrigine DRUG

Open label treatment per standard of care for bipolar disorder for six weeks.

Also known as: Lamictal

Mood stabilizer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Mood and Anxiety Disorders Program

Atlanta, Georgia, 30306, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium; Lithium Carbonate; Valproic Acid; Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Boadie Dunlop
• Organization: Emory University

bdunlop@emory.edu

404-727-8969

Study Officials

• Boadie W Dunlop, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: November 1, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-05

Locations

US (1)