FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder

Phase 4

Completed

Conditions: Bipolar Disorder

Interventions: Drug: Lithium

Registration Number: NCT00596622

Lead Sponsor: Indiana University

Brief Summary: This study will assess the effects of bipolar disorder on brain activity and will determine if medication changes the brain activity in people with bipolar disorder.

Detailed Description: Bipolar disorder (BD) is a chronic brain disorder that causes dramatic changes in a person's mood and energy. People with BD undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. A person undergoing an episode of mania often experiences euphoric moods, increased energy, and aggressive behaviors, while a person in a depressed state often experiences low moods, lack of energy, and feelings of sadness. Researchers have recently discovered that abnormalities in certain brain areas that control emotion are often present in those with BD. It is believed that the severe mood shifts in BD may cause alterations in normal brain activity, specifically in corticolimbic activation and connectivity. Current mood stabilizing medications used to treat people with BD may help normalize these brain activity abnormalities. This study will assess the effects of BD on brain activity using functional magnetic resonance imaging (fMRI) and will determine if treatment with lithium changes the brain activity in people with BD.

This 9-week study will include participants who are healthy, have BD, or are siblings of subject with BD. All potential participants will undergo initial testing, which will include a physical examination, blood tests, and an electrocardiogram (EKG). Participants will also be asked to answer questions about their mental health, drug use, personality, family history, and psychological well-being. Eligible participants will then return on a different day to undergo an MRI scan, taking 4 hours to complete. During the scan, participants will be asked to perform tasks designed to show changes in blood flow in specific brain regions. These tasks will include listening to sounds and looking at various letters, words, and pictures. This will mark the completion of the study for healthy participants, first degree relatives, and those participants with BD who do not wish to receive medication treatment.

Following the first MRI scan, participants with BD who wish to undergo medication treatment will begin an 8-week course of lithium. Participants will be asked to come to the clinic at least once a week for medication monitoring visits. During these visits, participants will undergo blood draws and assessments on depression and mania. Participants will return for two repeat MRI scans after Weeks 2 and 8 of lithium treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bipolar Depressed Subjects Treated	Lithium	Bipolar depression picture response during fMRI before and after treatment with lithium
Bipolar Euthymic Subjects Treated	Lithium	Bipolar euthymia picture response before and after treatment with lithium
Bipolar Manic Subjects Treated	Lithium	Bipolar mania picture response during fMRI before and after treatment with lithium

Primary Outcome Measures

Name	Time	Method
17-item Hamilton Depression Rating Scale (HDRS)	Measured at Baseline and after 8 weeks of treatment	17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; \>20: severe and very severe depression.

Secondary Outcome Measures

Name	Time	Method
Young Mania Rating Scale	Baseline and 8 weeks	Gold standard scale to measure mania, Range 0 - 60; 12 - 15 mild mania; 15 - 20 moderate mania; \>20 severe mania