Decision-Making in Bipolar Disorder

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01463111

Enrollment

Registered

2011-11-01

Start date

2011-05-31

Completion date

2016-04-30

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar, Manic depression, Mood stabilizer, Decision, Neuroeconomics

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.

Interventions

DRUGLithium

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

DRUGValproate

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

DRUGLamotrigine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from May 2011 through April 2016.

Pre-assignment details

Of the 37 participants who consented for participation, 26 began study treatment. Eleven participants were screen failures.

Participants by arm

Arm	Count
Mood Stabilizer 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.	26
Total	26

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	5
Overall Study	Physician Decision	2
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Mood Stabilizer
Age, Continuous	36.19 years STANDARD_DEVIATION 12.41
Race/Ethnicity, Customized Caucasian	14 Participants
Race/Ethnicity, Customized Other	11 Participants
Region of Enrollment United States	26 Participants
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	9 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 26
other Total, other adverse events	8 / 26
serious Total, serious adverse events	0 / 26

Outcome results

Primary

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.

Time frame: Baseline, Week 6