Peroxisomal Defects and Familial Risk for Bipolar Disorder

NCT01237379 | Completed

• 1 other identifier: McNamara NARSAD
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Mania

Outcome Measures

Primary Outcomes (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 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 Outcomes (2)

• 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

Study Arms (4)

Health Controls

Bipolar Patients with High-Risk of Mania

Bipolar Patients with Ultra-High Risk

First Manic Episode Bipolar Youth

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• year old males \& females
• Based on currently enrolled study.

You may not qualify if:

• Based on currently enrolled study.

Sponsors & Collaborators

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

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

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.

MeSH Terms

Conditions

Bipolar Disorder; Mania

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert McNamara, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)