Peroxisomal Defects and Familial Risk for Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 10 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 -18 year old males & females
- •Based on currently enrolled study.
排除标准
- •Based on currently enrolled study.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
研究者
Robert McNamara
Associate Professor
University of Cincinnati
