| City: |
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Indianapolis |
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State:
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IN |
| Zip Code: |
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46222 |
| Conditions: |
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Bipolar Disorder |
| Purpose: |
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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.
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| Study summary: |
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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, siblings, 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. |
| Criteria: |
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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 full siblings of bipolar disorder subjects:
- Ages 15-60 years (inclusive) and able to give voluntary informed consent.
- Sibling (both parents the same) within 10 years of age of a BD patient taking part in
the study
- 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 full siblings 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:
- Current or past history of psychiatric illness or substance abuse or dependence in
self or a first degree relative
- 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 |
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| Study is available at: |
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Indiana University Psychiatric Clinic
Indianapolis, IN 46222
United States
Primary Contact:
Abigail D. French, MS
Email: abdfrenc@iupui.edu
Phone: 317-944-0318
Secondary Contact:
Abigail D. Gunn, MS
Email: abdfrenc@iupui.edu
Phone: 317-944-0318 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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