Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00457054|
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : September 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: Lithium||Phase 4|
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) between the different emotion regulating areas of the brain rather than in terms of increase or decrease in localized brain activity.
Specific Aim 2: Our second aim is to investigate whether lithium works by altering the connectivity of areas of the brain implicated in the pathophysiology of BD, thereby leading to changes in the abnormal positive or negative emotional reactions to the environment seen in mania and depression respectively.
Specific Aim 3: Out third aim is to investigate whether patients with the s/s or s/L alleles of the 5-HTTLPR polymorphism will have greater amygdalar activation and decreased cortico-amygdala connectivity compared to patients with L/L genotype. We will also investigate whether lithium treatment differentially affects these fMRI measures in the s/s or s/L and L/L genotypes.
We will study unmedicated subjects satisfying DSM-IV criteria for Bipolar Disorder current episode depressed or hypomanic/manic or who are euthymic. Subjects will undergo fMRI before and after 8 weeks of treatment with lithium a mood stabilizer that is known to be effective in both phases of BD. Healthy subjects will have a scan at baseline and after 8 weeks but will not be treated with any medication. We will also test for the serotonin transporter gene (the gene that controls the availability of a chemical called serotonin in the brain), which has been shown to effect how lithium works.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania Before and After Lithium Treatment: An Brain fMRI Study|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
- Comparative activation of amygdala and cortico-amydalar connectivity as measured by fMRI taken at baseline and eight weeks from baseline [ Time Frame: 07-03 to 3-07 ]
- Improvement of scores on Hamilton Depression Rating Scale given weekly for eight weeks [ Time Frame: 07-03 to 3-07 ]
- Improvement as measured by the Clinical Global Impression Severity and Improvement Scales given weekly for eight weeks [ Time Frame: 07-03 to 3-07 ]
- Improvement as measured by the Brief Psychiatric Rating Scale given weekly for eight weeks [ Time Frame: 07-03 to 3-07 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457054
|United States, Indiana|
|Indiana University Adult Psychiatry Clinic|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Amit Anand, MD||Indiana University School of Medicine|