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Peroxisomal Defects and Familial Risk for Bipolar Disorder

NCT ID: NCT01237379

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Overall Study Design: This study entails collecting fasting venous blood (20 ml) from, and administering the 'omega-3 questionnaire' to, subjects being recruited from ongoing National Institute of Mental Health (NIMH)-sponsored trials within the Department of Psychiatry, University of Cincinnati College of Medicine. Specifically, blood will be collected from 20 healthy controls (i.e., no personal or family history of any Axis I mood disorder according to the Diagnostic and Statistical Manual of Mental Disorders-IV \[DSM-IV\]) and 20 asymptomatic high-risk (i.e., have a biological parent with BD-I) adolescents (aged 10-18 years old) recruited for study MH077138 (UC-IRB #: 07-04-10-03, BITREC Project 3; PI: DelBello), 20 ultra-high risk (i.e., have a biological parent with BD-I and a Major Depressive Disorder (MDD) diagnosis) recruited for study MH083924 (UC-IRB #: 04-09-15-03, CO-Principal Investigators DelBello/McNamara), and 20 adolescents who are admitted for their first hospitalization and who have a diagnosis of BD-I recruited for study MH080973 (UC-IRB #: 08-10-30-01, Principal Investigator: DelBello). Blood will then be processed, and de-identified tubes sent to the Kennedy Krieger Institute, Peroxisomal Diseases Section, to determine the following measures of peroxisomal function: (1) plasma very long chain fatty acids (C24:0 \& C26:0) concentrations, (2) plasma bile acid C27 intermediate (dehydrocrepenynic acid {DHCA},tetrahydrocannabinolic acid {THCA})concentrations, (3) plasma pipecolic acid concentrations, and (4) Red Blood Cell (RBC) plasmalogen concentrations. Additionally, RBC fatty acid composition will be determined by gas chromatography, and platelet function and plasma inflammatory markers assayed using commercially available kits according to manufacturer's instructions.

Conditions

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Bipolar Disorder Mania

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Health Controls

No interventions assigned to this group

Bipolar Patients with High-Risk of Mania

No interventions assigned to this group

Bipolar Patients with Ultra-High Risk

No interventions assigned to this group

First Manic Episode Bipolar Youth

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 10 -18 year old males \& females
* Based on currently enrolled study.

Exclusion Criteria

* Based on currently enrolled study.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Robert McNamara

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert McNamara, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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McNamara NARSAD

Identifier Type: -

Identifier Source: org_study_id