Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes

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.

NCT Number	NCT05957055
Lead Sponsor	Medical University of Lodz Collaborators: Medical University of Silesia, Medical University of Gdansk, Institute of Medical Sciences of the University of Opole, Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz
Conditions	Attention Deficit Disorder with Hyperactivity, Diabetes Mellitus, Type 1
Enrollment	150 participants
Start Date	2024-02-05
Primary Completion	2027-12-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2024-11-29