- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237379
Peroxisomal Defects and Familial Risk for Bipolar Disorder
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- University of Cincinnati
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Subject characteristics: All subjects will be 10-18 year old males and females. Up to 80 patients will be enrolled in this study. Subjects will be screened according to previously approved individual study criteria (UC-IRB #: 07-04-10-03; 04-09-15-03; 08-10-30-01).
Inclusion Criteria:
- 10 -18 year old males & females
- Based on currently enrolled study.
Exclusion Criteria:
- Based on currently enrolled study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Health Controls
|
Bipolar Patients with High-Risk of Mania
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Bipolar Patients with Ultra-High Risk
|
First Manic Episode Bipolar Youth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1 day
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peroxisomal function will be inversely correlated with manic and depression symptom severity scores.
Time Frame: 1 day
|
Prediction 3: Graded deficits in measures of 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.
Time Frame: 1 day
|
Prediction 2: Indices of peroxisomal function will be correlated with RBC DHA composition.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- McNamara NARSAD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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