Lisdexamphetamine vs Methylphenidate for Pediatric Patients With ADHD and Type 1 Diabetes
Status:
Not yet recruiting
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
This clinical trial aims to evaluate the safety and effectiveness of an intervention
involving parental training in behaviour management and medication in children with both Type
1 Diabetes (T1D) and Attention Deficit Disorder with Hyperactivity (ADHD). ADHD is a
neurodevelopmental disorder that affects around 5% of school-age children and adolescents,
while T1D is a chronic disease requiring strict management.
After initial parental training provided for parents/legal guardians, the children will be
randomized to one of two cross-over groups, and treated with either lisdexamfetamine or
methylphenidate first. After dose optimization for first 5-7 weeks, patients will be treated
for 6 months total, after which they will be switched to the other drug.
Researchers will then compare the ADHD symptom severity as measured by Conners 3
questionnaire, and compare the frequency of any adverse events associated with the therapy.
As secondary outcomes, patient's T1D control and quality of life will be compared between the
two drugs.
Phase:
Phase 2
Details
Lead Sponsor:
Medical University of Lodz
Collaborators:
Institute of Medical Sciences of the University of Opole Medical University of Gdansk Medical University of Silesia Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz