Status:
UNKNOWN
A Clinical Study Evaluating the Efficacy and Safety of Retinoic Acid in Patients With 15q11-q13 Duplication Syndrome
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Autism
Treatment Adherence
Eligibility:
All Genders
6-18 years
Phase:
EARLY_PHASE1
Brief Summary
Autism Spectrum Disorders (ASD), with its core symptoms of communication and repetitive behaviors, is a serious neurodevelopmental disorder common in childhood and affects about 1% of children. So far...
Eligibility Criteria
Inclusion
- Between 6 and 18 years old
- Clinical diagnosis + scale diagnosis of autism (1) Clinical diagnosis: clinical diagnosis was made by 2 experienced doctors according to the medical history provided by the caregivers and the diagnostic criteria of ASD in DSM-V; (2) Scale diagnosis: The diagnostic assessment was conducted by highly qualified practitioners taking the ADOS-2 score, Restricted Behabior (RRB) and Social Affect (SA) scores. The scores were converted to standardized severity scores (CSS) for three diagnoses of non-spectrum disorders, autism and autism spectrum disorders.
- Genetics: 15q11-13 duplicates diagnosed by SNP-Array or A-CGH microarray, including UBE3A gene
Exclusion
- A history of acute or chronic infection within the last 3 months
- There are still active seizures within the past 1 year
- Have taken vitamin and/or mineral supplements within the last 6 months
- A history of chronic diseases, including abnormal liver function, abnormal kidney function, and abnormal thyroid function;
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05281965
Start Date
April 1 2022
End Date
June 1 2024
Last Update
March 16 2022
Active Locations (2)
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1
Zhejiang University
Hangzhou, Zhejiang, China, 310000
2
Miao pu
Hangzhou, China, 310009