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临床试验/NCT04382716
NCT04382716已完成不适用

Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS): Clinical Characterization and Prospective Course

University of Minnesota1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Predictors

研究概览

简要总结

This study is a brief (3 month) longitudinal study following children between the ages of 4-16 years old who have been diagnosed with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). Parents and children (who are at a 2nd grade reading level) will complete questionnaires online or in person weekly for 3 months. Additionally, parents will track their child's symptoms 3 times/week using a mobile application for 3 months. The investigators are hoping to begin to characterize the longitudinal trajectory of neuropsychiatric symptoms in children with PANS. Additionally, the study will seek to identify baseline demographic and clinical characteristics (e.g., gender, recent onset versus chronic course, GAS versus other triggers) that predict severity of baseline neuropsychiatric symptoms and predict change in symptoms over time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • English-speaking boys and girls ages 4-16 years
  • Abrupt onset of OCD or severely restricted food intake
  • At least 2 equally abrupt-onset concurrent neuropsychiatric symptoms from the following 7 categories: anxiety, emotional lability/depression, irritability/aggression/severely oppositional behaviors, behavioral/developmental regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g., urinary, sleep)
  • Neuropsychiatric symptoms are not better explained by a known neurological or medical disorder.

排除标准

  • Too unstable psychiatrically or medically to participate safely in the protocol, per clinical judgment of the Principal Investigator or Co-Investigator

结局指标

主要结局

Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Predictors

时间窗: Week 12

Investigators will report items from the baseline Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale that predict symptom severity across the study using a regression analysis.

Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Agreement

时间窗: Week 12

Investigators will also report agreement between parent and child Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale total scores across the study. Agreement will be reported using correlations.

Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Compliance

时间窗: Week 12

Investigators will report overall compliance rates (percentage of completed questionnaires) for the Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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