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The purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of Bipolar disorder.
Individuals with bipolar disorder or those with a history of bipolar disorder may have certain structural changes in their brain. The purpose of this study is to look at those changes, as well as the assessment of risk factors for bipolar disorders, involving both social and psychological aspects of behavior, age, education, marital relations, nutrition, physical activity, etc., compared with persons not having bipolar disorder. These changes in the brain will be measured by Magnetic Resonance Imaging (MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manic Subject with DWM Hyperintensities >2 | Subjects with acute mania who were treated with naturalistic protocol (starting with valproic acid) who had a BOYKO DWM Hyperintensity rating >2 and a YMRS <15 at week 3. |
| |
| Manic Subjects with DWM Hyperintensities <3 | Subjects with acute mania who were treated with naturalistic protocol (starting with valproic acid)who had a BOYKO DWM Hyperintensity rating <3 and a YMRS <15 at week 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproic Acid | Drug | Tablets, 250mg-3000mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania | Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. | 3 weeks |
| Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment | Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment | Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects recruited from the adult inpatient and outpatient psychiatric clinics at Duke University Medical Center and John Umstead Hospital (Butner, NC).
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| Name | Affiliation | Role |
|---|---|---|
| John L Beyer, M.D | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
Only subjects currently in a manic episode were recruited for the acute treatment protocol substudy.
Patients were recruited from 2005-2009 from the inpatient units and Duke University Medical Center and John Umstead Hospital and the outpatient clinics at DUMC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Naturalistic Treatment | Acutely manic subjects were treated using the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) expert consensus guidelines beginning with valproic acid (titrated to therapeutic levels) over a three week period. If there was a non-response to this intervention, then a subject would continue acute treatment using other interventions indicated by STEP-BD protocols. After stabilization, subjects were followed monthly up to a year's duration and treated using the STEP-BD expert consensus guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute Treatment -- 3 Weeks |
| |||||||||||||
| Continuation Treatment -- up to 12 Month |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naturalistic Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania | Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. | All subjects in an acute manic state who were treated with specified protocol. | Posted | Number | participants | 3 weeks |
|
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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 | Naturalistic Treatment | Patients were treated acutely using expert consensus guidelines beginning with valproic acid. After stabilization, subjects were followed monthly up to a year's duration and treated using expert consensus guidelines. indicated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lithium Toxicity | Nervous system disorders | Non-systematic Assessment | Patient was readmitted after being found to be lithium toxic. Condition resolved without treatment. No sequela noted. |
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Acute MRI hypothesis unable to be tested due to high subject response. Five subject scans could not be evaluated by DTI computer program.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Beyer, MD | Duke University Medical Center | 919-668-0209 | john.beyer@dm.duke.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 |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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DNA collected for genetic databank.
| up to 12 months |
| fa LOFC in Subjects Who Received Continuation Treatment | As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions. | up to 12 months |
| fa ROFC in Subjects Who Received Continuation Treatment | As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions. | up to 12 months |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Non-Responders to Acute Treatment | Subjects in an acute manic episode who did not respond to treatment as measured by a YMRS >15 by week 3. |
|
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| Primary | Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment | Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15. | Subjects who completed at least 4-12 months of consistent follow up appointments after stabilization from an acute manic episode. Note that 3 subjects dropped out of continuation treatment. | Posted | Number | participants | 12 months |
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| Secondary | Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment | Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). | Number of subjects who who had >2 on the DWM hyperintensity assessment from the Boyko classification system. | Posted | Number | participants | up to 12 months |
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| Secondary | fa LOFC in Subjects Who Received Continuation Treatment | As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions. | Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data. | Posted | Mean | Standard Deviation | units on a scale | up to 12 months |
|
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|
| Secondary | fa ROFC in Subjects Who Received Continuation Treatment | As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions. | Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data. | Posted | Mean | Standard Deviation | units on a scale | up to 12 months |
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| 1 |
| 19 |
| 0 |
| 19 |
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| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |