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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Lithium Carbonate

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