FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Lithium
Intervention type(s): Drug
Intervention description(s): Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.
Intervention MeSH terms: Lithium Carbonate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Major Depressive or Manic Episodes; Bipolar; Mania; Depression; Lithium; fMRI; Pictures; Brain Scan