Status:
COMPLETED
Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to find out what parts of the brain have increased or decreased activity with individuals who have bipolar disorder and how medicine changes this activity in bipolar subje...
Detailed Description
Aim 1: Our first aim is to use a novel fMRI experimental paradigm to investigate the pathophysiology of bipolar disorder (BD) in terms of the strength of connectivity (as measured by LFBF correlations...
Eligibility Criteria
Inclusion
- Inclusion criteria for Bipolar Subjects
- Ages 18-60 years and able to give voluntary informed consent.
- Satisfy criteria for Bipolar Depression using the Structured Clinical Interview for Diagnostic and Statistical Manual -4th edition (DSM-IV) (SCID-IV).
- Bipolar depressed subjects: 25-item Hamilton Depression Rating Scale (HDRS) score \> 18.Young Mania Rating Score (YMRS)\<10.
- Bipolar hypomanic/manic subjects will have a YMRS score\>12 and a 25-item HDRS score\<10.
- Bipolar Euthymic subjects will have YMRS score \< 10 and HDRS score \< 10 and would have been euthymic for \> 14 days.
- Subjects will be drug and medication free and would have no significant history of medical or neurological illness.
- Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire
- Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:
- Symptoms not worsening by more than 10 points on either the HDRS or the YMRS during the course of the study.
- No danger to self or others.
- No psychotic symptoms.
- Inclusion criteria for Healthy Subjects:
- Ages 18-60 years and able to give voluntary informed consent.
- No history of psychiatric illness or substance abuse or dependence as assessed by SCID for non-patients (SCID-NP).
- No significant family history of psychiatric or neurological illness.
- Not currently taking any prescription or centrally acting medications.
- No serious medical or neurological illness as assessed by history, physical examination and laboratory examination including CBC and blood chemistry.
Exclusion
- Exclusion criteria for Bipolar Subjects
- Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
- Use of neuroleptic past 2 weeks
- Use of antidepressants in the past 2 weeks. If on fluoxetine in the past then should not have been on this medication for 4 weeks.
- Use of mood stabilizers in the past 2 weeks
- Use of benzodiazepines in the past 2 weeks.
- Acutely suicidal or homicidal or requiring inpatient treatment.
- Meeting DSM-IV criteria for other substance dependence within the past year, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
- Use of alcohol in the past 1 week.
- No serious medical or neurological illness as assessed by physical examination and laboratory examination including complete blood count (CBC) and blood chemistry.
- Current pregnancy or breast feeding.
- Metallic implants.
- Previously known positive Human Immunodeficiency Virus (HIV) blood test as reported by the subject.
- Exclusion criteria for Healthy Subjects:
- Under 18 years of age.
- Pregnant or breast feeding.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00457054
Start Date
July 1 2003
End Date
March 1 2007
Last Update
September 28 2011
Active Locations (1)
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1
Indiana University Adult Psychiatry Clinic
Indianapolis, Indiana, United States, 46202