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

PANDAS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382716
• Other study ID #: University_of_Minnesota
• Status: Completed
• Start date: May 2, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: May 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• PANDAS
• PANS

Intervention

Other:
• No intervention
No intervention; observation only

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Compliance	Investigators will report overall compliance rates (percentage of completed questionnaires) for the Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale.	Week 12
Primary	Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Agreement	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.	Week 12
Primary	Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Predictors	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.	Week 12