Decision-Making in Bipolar Disorder

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01463111
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arm: 1
• Duration (Months): 59
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Lithium; Drug: Valproate; Drug: Lamotrigine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Decision-Making in Bipolar Disorder
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

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.	Drug: Lithium; Open label treatment per standard of care for bipolar disorder for six weeks.; Other Names: 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 Names: Lamictal

Outcome Measures

Primary Outcome Measures

1. Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ) [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.

2. Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ) [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.

3. Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ) [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.

4. Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ) [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

1. Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boadie W. Dunlop, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT01463111
• Other Study ID Numbers: IRB00050442; BDDM
• First Posted: Nov 1, 2011
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

• Keywords provided by Boadie W. Dunlop, Assistant Professor, Emory University: Bipolar; Manic depression; Mood stabilizer; Decision; Neuroeconomics
• Additional relevant MeSH terms: Bipolar Disorder; Lamotrigine; Valproic Acid

Study Results

Participant Flow

Recruitment Details	Participants were recruited from May 2011 through April 2016.
Pre-assignment Detail	Of the 37 participants who consented for participation, 26 began study treatment. Eleven participants were screen failures.

Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
Period Title: Overall Study
STARTED	26
COMPLETED	17
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
Overall Participants	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.19 (12.41)
Sex: Female, Male (Count of Participants)
Female	17 65.4%
Male	9 34.6%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	14 53.8%
Other	11 42.3%
Region of Enrollment (Count of Participants)
United States	26 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data was analyzed for participants who completed all study visits. Means are age-adjusted.

Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
Measure Participants	17
Mean (Standard Error) [units on a scale]	.176 (.778)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data was analyzed for participants who completed all study visits. Means are age-adjusted.

Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
Measure Participants	17
Mean (Standard Error) [units on a scale]	-3.41 (3.08)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data was analyzed for participants who completed all study visits. Means are age-adjusted.

Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
Measure Participants	17
Mean (Standard Error) [units on a scale]	-2.23 (3.72)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Data was analyzed for participants who completed all study visits. Means are age-adjusted.

Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
Measure Participants	17
Mean (Standard Error) [units on a scale]	2.47 (3.41)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data was analyzed for participants who completed all study visits. Means are age-adjusted.

Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
Measure Participants	17
Attentional	-3.941 (3.716)
Motor	-4.063 (3.108)
Non-planning	-2.625 (5.227)

Adverse Events

Time Frame	Adverse events were collected throughout the duration of the study.
Arm/Group Title	Mood Stabilizer
Arm/Group Description	Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks. Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks.
All Cause Mortality
	Mood Stabilizer
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Serious Adverse Events
	Mood Stabilizer
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Other (Not Including Serious) Adverse Events
	Mood Stabilizer
	Affected / at Risk (%)	# Events
Total	8/26 (30.8%)
Ear and labyrinth disorders
Dizziness/Vertigo	2/26 (7.7%)	2
Eye disorders
Blurred Vision	1/26 (3.8%)	1
Gastrointestinal disorders
Nausea/Vomiting	5/26 (19.2%)	5
Stomach Ulcer	1/26 (3.8%)	1
Gastroenteritis	1/26 (3.8%)	1
Diarrhea	2/26 (7.7%)	2
General disorders
Fever	1/26 (3.8%)	1
Edema	1/26 (3.8%)	1
Infections and infestations
Laryngitis	1/26 (3.8%)	1
Influenza	1/26 (3.8%)	1
Injury, poisoning and procedural complications
Bruising	1/26 (3.8%)	1
Investigations
Weight Gain	3/26 (11.5%)	3
Metabolism and nutrition disorders
Increased Appetite	2/26 (7.7%)	2
Thirst	3/26 (11.5%)	3
Musculoskeletal and connective tissue disorders
Weakness	1/26 (3.8%)	1
Neck Pain	1/26 (3.8%)	1
Nervous system disorders
Hand Tremor	1/26 (3.8%)	1
Psychiatric disorders
Self-Injury	1/26 (3.8%)	1
Insomnia	1/26 (3.8%)	1
Sedation	2/26 (7.7%)	2
Impaired Concentration	1/26 (3.8%)	1
Increased Sexual Interest	1/26 (3.8%)	1
Elevated Mood	1/26 (3.8%)	1
Increased Anxiety	1/26 (3.8%)	1
Renal and urinary disorders
Increased Urination	2/26 (7.7%)	2
Reproductive system and breast disorders
Chlamydia Infection	1/26 (3.8%)	1
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection	3/26 (11.5%)	3
Dyspnea	1/26 (3.8%)	1
Skin and subcutaneous tissue disorders
Rash	1/26 (3.8%)	1
Pruritis	1/26 (3.8%)	1
Surgical and medical procedures
Bartholin Cyst Removal	1/26 (3.8%)	1
Vascular disorders
Headache	6/26 (23.1%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.