Peroxisomal Defects and Familial Risk for Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Robert McNamara, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01237379
First received: October 21, 2010
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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
Bipolar Disorder
Mania

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Peroxisomal Defects and Familial Risk for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • peroxisomal function will be inversely correlated with manic and depression symptom severity scores. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prediction 3: Graded deficits in measures of peroxisomal function will be inversely correlated with manic and depression symptom severity scores.

  • Indices of peroxisomal function will be correlated with RBC DHA composition. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prediction 2: Indices of peroxisomal function will be correlated with RBC DHA composition.


Biospecimen Retention:   None Retained

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.


Enrollment: 80
Study Start Date: October 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Health Controls
Bipolar Patients with High-Risk of Mania
Bipolar Patients with Ultra-High Risk
First Manic Episode Bipolar Youth

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 {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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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).

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01237379

Locations
United States, Ohio
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
  More Information

No publications provided

Responsible Party: Robert McNamara, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01237379     History of Changes
Other Study ID Numbers: McNamara NARSAD
Study First Received: October 21, 2010
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014