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

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.

Timeline

Start

2024-02-05

Primary completion

2027-12-01

Completion

2027-12-01

Publications

• Background Michalak A, Chrzanowski J, Kusmierczyk-Koziel H, Klejman E, Blaziak K, Mianowska B, Szadkowska A, Chobot AP, Jarosz-Chobot P, Mysliwiec M, Makowska I, Kalenik A, Zamarlik M, Wolanczyk T, Fendler W, Butwicka A. Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting. BMJ Open. 2023 Dec 12;13(12):e078112. doi: 10.1136/bmjopen-2023-078112.

Drugs

Indications