Trial Outcomes & Findings for Decision-Making in Bipolar Disorder (NCT NCT01463111)
NCT ID: NCT01463111
Last Updated: 2017-05-31
Results Overview
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.
COMPLETED
NA
37 participants
Baseline, Week 6
2017-05-31
Participant Flow
Participants were recruited from May 2011 through April 2016.
Of the 37 participants who consented for participation, 26 began study treatment. Eleven participants were screen failures.
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
26
|
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Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
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Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Decision-Making in Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Mood Stabilizer
n=26 Participants
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.
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|---|---|
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Age, Continuous
|
36.19 years
STANDARD_DEVIATION 12.41 • n=99 Participants
|
|
Sex: Female, Male
Female
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17 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Other
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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26 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Data was analyzed for participants who completed all study visits. Means are age-adjusted.
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.
Outcome measures
| Measure |
Mood Stabilizer
n=17 Participants
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.
|
|---|---|
|
Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
|
.176 units on a scale
Standard Error .778
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Data was analyzed for participants who completed all study visits. Means are age-adjusted.
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.
Outcome measures
| Measure |
Mood Stabilizer
n=17 Participants
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.
|
|---|---|
|
Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
|
-3.41 units on a scale
Standard Error 3.08
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PRIMARY outcome
Timeframe: Baseline, Week 6Population: Data was analyzed for participants who completed all study visits. Means are age-adjusted.
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.
Outcome measures
| Measure |
Mood Stabilizer
n=17 Participants
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.
|
|---|---|
|
Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
|
-2.23 units on a scale
Standard Error 3.72
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Data was analyzed for participants who completed all study visits. Means are age-adjusted.
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.
Outcome measures
| Measure |
Mood Stabilizer
n=17 Participants
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.
|
|---|---|
|
Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ)
|
2.47 units on a scale
Standard Error 3.41
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Data was analyzed for participants who completed all study visits. Means are age-adjusted.
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.
Outcome measures
| Measure |
Mood Stabilizer
n=17 Participants
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.
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|---|---|
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Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score
Attentional
|
-3.941 units on a scale
Standard Error 3.716
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|
Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score
Motor
|
-4.063 units on a scale
Standard Error 3.108
|
|
Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score
Non-planning
|
-2.625 units on a scale
Standard Error 5.227
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Adverse Events
Mood Stabilizer
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mood Stabilizer
n=26 participants at risk
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.
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|---|---|
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Surgical and medical procedures
Bartholin Cyst Removal
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3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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Reproductive system and breast disorders
Chlamydia Infection
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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Nervous system disorders
Hand Tremor
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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|
Metabolism and nutrition disorders
Increased Appetite
|
7.7%
2/26 • Number of events 2 • Adverse events were collected throughout the duration of the study.
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Vascular disorders
Headache
|
23.1%
6/26 • Number of events 6 • Adverse events were collected throughout the duration of the study.
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Psychiatric disorders
Self-Injury
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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Gastrointestinal disorders
Nausea/Vomiting
|
19.2%
5/26 • Number of events 5 • Adverse events were collected throughout the duration of the study.
|
|
General disorders
Fever
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
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Renal and urinary disorders
Increased Urination
|
7.7%
2/26 • Number of events 2 • Adverse events were collected throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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Gastrointestinal disorders
Stomach Ulcer
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
11.5%
3/26 • Number of events 3 • Adverse events were collected throughout the duration of the study.
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|
Infections and infestations
Laryngitis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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|
Psychiatric disorders
Sedation
|
7.7%
2/26 • Number of events 2 • Adverse events were collected throughout the duration of the study.
|
|
Metabolism and nutrition disorders
Thirst
|
11.5%
3/26 • Number of events 3 • Adverse events were collected throughout the duration of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
2/26 • Number of events 2 • Adverse events were collected throughout the duration of the study.
|
|
Infections and infestations
Influenza
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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|
Investigations
Weight Gain
|
11.5%
3/26 • Number of events 3 • Adverse events were collected throughout the duration of the study.
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|
Injury, poisoning and procedural complications
Bruising
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
General disorders
Edema
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Psychiatric disorders
Impaired Concentration
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Psychiatric disorders
Increased Sexual Interest
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Eye disorders
Blurred Vision
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Psychiatric disorders
Elevated Mood
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Psychiatric disorders
Increased Anxiety
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Ear and labyrinth disorders
Dizziness/Vertigo
|
7.7%
2/26 • Number of events 2 • Adverse events were collected throughout the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.8%
1/26 • Number of events 1 • Adverse events were collected throughout the duration of the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place