NCT01237379|Completed
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Sponsor study identifier
observational
80
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
October 2013
Actual (reported)The purpose of this study is to screen for peroxisome defects in child and adolescent offspring of Bipolar Disorder I (BD-I) parents at different stages of risk for transitioning to mania and following the onset of mania. Prediction 1: Youth with an elevated risk for developing BD-I and first-episode manic patients will exhibit graded deficits in measures of peroxisomal function compared with healthy controls. Prediction 2: Indices of peroxisomal function will be correlated with Red Blood Cells Docosahexaenoic acid (DHA) composition. Prediction 3: Graded deficits in measures of peroxisomal function will be inversely correlated with manic and depression symptom severity scores.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 21, 2010
Actual (reported)November 9, 2010
Actual (reported)October 2013
Actual (reported)October 2013
Actual (reported)Youth with an elevated risk for developing BD-I and first-episode manic patients will exhibit graded deficits in measures of peroxisomal function compared with healthy controls.
Prediction 1: Youth with an elevated risk for developing BD-I and first-episode manic patients will exhibit graded deficits in measures of peroxisomal function compared with healthy controls.
1 day
peroxisomal function will be inversely correlated with manic and depression symptom severity scores.
1 day
Indices of peroxisomal function will be correlated with RBC DHA composition.
1 day
Subjects: In order to accomplish this aim, 20 healthy controls, 20 high-risk, 20 ultra-high risk, and 20 first-episode manic youth (ages 10-18 years old) will be recruited at a rate of 1 subject/group per month over the first 20 months. Subjects being recruited from the following IRB approved NIMH-sponsored trials: MH077138 (UC-IRB #: 07-04-10-03, BITREC Project 3; PI: DelBello), MH083924 (UC-IRB #: 04-09-15-03, CO-PIs DelBello/McNamara), and MH080973 (UC-IRB #: 08-10-30-01, PI: DelBello).
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Laboratory methods: The gas chromatography procedure used to determine red blood cell fatty acid composition. Briefly, total fatty acid composition will be determined. Indices of peroxisome function, including (1) plasma very long chain fatty acids concentrations, (2) plasma bile acid C27 intermediate concentrations, (3) plasma pipecolic acid concentrations, and (4) RBC plasmalogen concentrations, will be determined by liquid chromatography tandem mass spectrometry and gas chromatography. Plasma cytokine and C-Reactive Protein (CRP)concentrations will be determined. All blood analyses will be performed by a technician blinded to diagnostic group identity.
Robert McNamara, PhD
University of Cincinnati
80 participants (actual enrollment reported by the registry).
First Submitted
October 21, 2010
First Posted
November 9, 2010
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
Contact the study team to confirm eligibility.
Primary Completion
October 2013
Actual (reported)Study Completion
October 2013
Actual (reported)Last Updated
December 23, 2014
Record last verified: 2014-12
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