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Peroxisomal Defects and Familial Risk for Bipolar Disorder

Sponsor
University of Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT01237379
Collaborator
National Alliance for Research on Schizophrenia and Depression (Other)
80
Enrollment
1
Location
36
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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 ,tetrahydrocannabinolic acid )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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Retrospective
    Official Title:
    Peroxisomal Defects and Familial Risk for Bipolar Disorder
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2013
    Actual Study Completion Date :
    Oct 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Health Controls
    Bipolar Patients with High-Risk of Mania
    Bipolar Patients with Ultra-High Risk
    First Manic Episode Bipolar Youth

    Outcome Measures

    Primary Outcome Measures

    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]

      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.

    Secondary Outcome Measures

    1. peroxisomal function will be inversely correlated with manic and depression symptom severity scores. [1 day]

      Prediction 3: Graded deficits in measures of peroxisomal function will be inversely correlated with manic and depression symptom severity scores.

    2. Indices of peroxisomal function will be correlated with RBC DHA composition. [1 day]

      Prediction 2: Indices of peroxisomal function will be correlated with RBC DHA composition.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cincinnati Cincinnati Ohio United States 45219

    Sponsors and Collaborators

    • University of Cincinnati
    • National Alliance for Research on Schizophrenia and Depression

    Investigators

    • Principal Investigator: Robert McNamara, PhD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert McNamara, Associate Professor, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01237379
    Other Study ID Numbers:
    • McNamara NARSAD
    First Posted:
    Nov 9, 2010
    Last Update Posted:
    Dec 23, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Bipolar Disorder

    Study Results

    No Results Posted as of Dec 23, 2014