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| ID | Type | Description | Link |
|---|---|---|---|
| BDDM | Other Identifier | Other |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mood stabilizer | Other | Participants diagnosed with Bipolar Disorder will receive standard of care open-label treatment with a mood stabilizer for six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Drug | Open label treatment per standard of care for bipolar disorder for six weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boadie W Dunlop, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Mood and Anxiety Disorders Program | Atlanta | Georgia | 30306 | United States |
Of the 37 participants who consented for participation, 26 began study treatment. Eleven participants were screen failures.
Participants were recruited from May 2011 through April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was analyzed for participants who completed all study visits. Means are age-adjusted. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
Adverse events were collected throughout the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bartholin Cyst Removal | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Boadie Dunlop | Emory University | 404-727-8969 | bdunlop@emory.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| D016651 | Lithium Carbonate |
| D014635 | Valproic Acid |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Valproate | Drug | Open label treatment per standard of care for bipolar disorder for six weeks. |
|
|
| Lamotrigine | Drug | Open label treatment per standard of care for bipolar disorder for six weeks. |
|
|
| Baseline, Week 6 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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. | Data was analyzed for participants who completed all study visits. Means are age-adjusted. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
|
|
| 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. | Data was analyzed for participants who completed all study visits. Means are age-adjusted. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
|
|
| Primary | 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. | Data was analyzed for participants who completed all study visits. Means are age-adjusted. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score | 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. | Data was analyzed for participants who completed all study visits. Means are age-adjusted. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 8 |
| 26 |
| Chlamydia Infection | Reproductive system and breast disorders | Systematic Assessment |
|
| Hand Tremor | Nervous system disorders | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Vascular disorders | Systematic Assessment |
|
| Self-Injury | Psychiatric disorders | Systematic Assessment | Self-injury refers to cutting oneself due to psychological reasons. |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Increased Urination | Renal and urinary disorders | Systematic Assessment |
|
| Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stomach Ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Laryngitis | Infections and infestations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Sedation | Psychiatric disorders | Systematic Assessment |
|
| Thirst | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Weight Gain | Investigations | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Edema | General disorders | Systematic Assessment |
|
| Impaired Concentration | Psychiatric disorders | Systematic Assessment |
|
| Increased Sexual Interest | Psychiatric disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Elevated Mood | Psychiatric disorders | Systematic Assessment |
|
| Increased Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Dizziness/Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D008670 |
| Metals |
| D002254 | Carbonates |
| D000468 | Alkalies |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|