This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Decision-Making in Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier:
NCT01463111
First received: June 2, 2011
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention
Bipolar Disorder Drug: Lithium Drug: Valproate Drug: Lamotrigine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Decision-Making in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Boadie W. Dunlop, Emory University:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Secondary Outcome Measures:
  • Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score [ Time Frame: Baseline, Week 6 ]
    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.


Enrollment: 37
Study Start Date: May 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mood stabilizer
Participants diagnosed with Bipolar Disorder will receive standard of care open-label treatment with a mood stabilizer for six weeks.
Drug: Lithium
Open label treatment per standard of care for bipolar disorder for six weeks.
Other Name: Eskalith
Drug: Valproate
Open label treatment per standard of care for bipolar disorder for six weeks.
Other Names:
  • Valproic Acid
  • Depakote
Drug: Lamotrigine
Open label treatment per standard of care for bipolar disorder for six weeks.
Other Name: Lamictal

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463111

Locations
United States, Georgia
Emory University Mood and Anxiety Disorders Program
Atlanta, Georgia, United States, 30306
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Boadie W Dunlop, MD Emory University
  More Information

Responsible Party: Boadie W. Dunlop, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01463111     History of Changes
Other Study ID Numbers: IRB00050442
BDDM ( Other Identifier: Other )
Study First Received: June 2, 2011
Results First Received: March 21, 2017
Last Updated: May 2, 2017

Keywords provided by Boadie W. Dunlop, Emory University:
Bipolar
Manic depression
Mood stabilizer
Decision
Neuroeconomics

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Lamotrigine
Valproic Acid
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 18, 2017