FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 15 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Major Depressive or Manic Episodes; Bipolar; Mania; Depression; Lithium; fMRI; Pictures; Brain Scan

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.
    

Eligibility criteria:

        Inclusion criteria for BD participants:

          -  Meets DSM-IV criteria for bipolar I or II disorder

          -  Meets criteria to undergo an MRI scan based on MRI screening questionnaire

          -  Suited for outpatient care during the study as ascertained by a score of less than 5
             on the Clinical Global Severity Scale, no significant suicidal or homicidal ideation,
             and no severe disability

        Inclusion criteria for BD depressed participants:

          -  Meets criteria for DSM-IV depressive episode-current

          -  Score of greater than 15 but less than 30 on the 17-item HDRS

          -  Score of less than 12 on the Young Mania Rating Scale

        Inclusion criteria for BD (hypo) manic participants:

          -  Meets criteria for DSM-IV manic episode-current

          -  Score of less than or equal to 18 on the 17-item HDRS

          -  Score of greater than 12 but less than 25 on the Young Mania Rating Scale

        Inclusion criteria for BD euthymic patients:

          -  Satisfy criteria for DSM-IV for euthymic state-current for at least 2 weeks.

          -  17-item Hamilton Depression Rating Scale < 12; Young Mania Rating Scale score < 10

        Exclusion criteria for BD participants:

          -  Meets DSM-IV criteria for unipolar depression, schizophrenia, schizophreniform
             disorder, schizoaffective disorder, atypical psychosis, anxiety disorder as a primary
             diagnosis, mental retardation, or personality disorder

          -  Received electroconvulsive therapy in the 12 months prior to study entry

          -  Use of neuroleptics, mood stabilizers, or benzodiazepines in the 2 weeks prior to
             study entry

          -  Use of antidepressants in the 2 weeks prior to study entry

          -  Use of fluoxetine in the 5 weeks prior to study entry

          -  Use of lithium in the 6 months prior to study entry

          -  Acutely suicidal or homicidal or requiring inpatient treatment

          -  Meets DSM-IV criteria for substance/alcohol dependence, excluding caffeine or
             nicotine, in the 6 months prior to study entry or substance/alcohol abuse in the 3
             months prior to study entry

          -  Use of alcohol in the 1 week prior to study entry and refusal to avoid alcohol use
             during the course of the study

          -  Presence of serious acute or chronic medical or neurological illness, including
             previously known HIV positive status (due to possible CNS involvement) as assessed by
             history, physical examination, and laboratory examination

          -  Pregnant or breastfeeding

          -  Metallic implants or other contraindication to MRI

        Inclusion criteria for first degree relatives of bipolar disorder subjects:

          -  Ages 15-60 years (inclusive) and able to give voluntary informed consent.

          -  Have never satisfied criteria for DSM-IV BD.

          -  Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.

          -  17-item Hamilton Depression Rating Scale < 10; Young Mania Rating Scale score < 10

        Exclusion criteria for first degree relatives of bipolar disorder subjects:

          -  Under 15 years of age.

          -  Meeting DSM-IV criteria for current episode of unipolar depression

          -  Pregnant or breast feeding.

          -  Metallic implants or other contraindication to MRI.

          -  Currently taking any prescription or centrally acting medications.

          -  Serious acute or chronic medical or neurological illness as assessed by history,
             physical examination and laboratory examination including CBC and blood chemistry.

          -  Use of alcohol in the past 1 week and not being able to avoid alcohol use during the
             course of the study.

        Inclusion criteria for healthy subjects:

          -  Ages 18-60 years (inclusive) and able to give voluntary informed consent.

          -  No current or past history of psychiatric illness or substance abuse or dependence.

          -  No current or past history of psychiatric illness or substance abuse or dependence in
             a first degree relative.

        Exclusion criteria for healthy participants:

          -  Under 18 years of age

          -  Pregnant or breastfeeding

          -  Metallic implants or other contraindication to MRI

          -  Significant family history of psychiatric or neurological illness

          -  Currently taking any prescription or centrally acting medications

          -  Serious acute or chronic medical or neurological illness as assessed by history,
             physical examination, and laboratory examination

          -  Use of alcohol in the 1 week prior to study entry and refusal to avoid alcohol use
             during the course of the study