Bipolar Disorder in Late Life

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Bipolar Disorder in Late Life (Evaluation of MRI Hyperintensities and DTI in Bipolar Disorder)

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Valproic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes. 18 years of age and older, male or female, any race. Capacity to give informed consent and follow study procedures. Exclusion Criteria: History of alcohol/drug dependence Any metal or pacemaker in the body which precludes MRI Pregnancy Dementia or other primary psychiatric disorders including substance abuse/dependence, anxiety disorders, schizophrenia For controls, numbers one through four above as well as any history of depression or the use of antidepressants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Manic Subject with DWM Hyperintensities >2<br>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. | Drug: Valproic Acid<br>* Tablets, 250mg-3000mg<br>* Other names: Depakote;|
| Manic Subjects with DWM Hyperintensities <3<br>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. | Drug: Valproic Acid<br>* Tablets, 250mg-3000mg<br>* Other names: Depakote;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPD