Bipolar Disorder in Late Life

Completed

Conditions: Bipolar Disorder

Interventions: Drug: Valproic Acid

Registration Number: NCT00787930

Lead Sponsor: Duke University

Brief Summary: 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: 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Manic Subjects with DWM Hyperintensities <3	Valproic Acid	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.
Manic Subject with DWM Hyperintensities >2	Valproic Acid	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.

Primary Outcome Measures

Name	Time	Method
Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania	3 weeks	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.
Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment	12 months	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.

Secondary Outcome Measures

Name	Time	Method
fa ROFC in Subjects Who Received Continuation Treatment	up to 12 months	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.
Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment	up to 12 months	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).
fa LOFC in Subjects Who Received Continuation Treatment	up to 12 months	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.