RecruitingPhase 2NCT05957055

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

LAMAinDiab - Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial

Sponsor

Medical University of Lodz

Enrollment

150 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1 Attention Deficit Disorder with Hyperactivity

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.

Eligibility

Min Age: 8 YearsMax Age: 198 Months

Plain Language Summary

Simplified for easier understanding

This study in Poland is comparing two ADHD medications — lisdexamfetamine and methylphenidate — in children and teenagers who have both Type 1 diabetes and ADHD, to see which medication manages ADHD symptoms more effectively while maintaining safe blood sugar levels. **You may be eligible if...** - You are 8 to 16.5 years old with a confirmed diagnosis of both Type 1 diabetes (for at least 12 months) and ADHD - Your blood sugar is managed with intensive insulin therapy - You have Polish citizenship and health insurance **You may NOT be eligible if...** - Your blood sugar is currently very poorly controlled (average HbA1c over 12% in the past year) - Your diabetes is in partial remission (very low insulin dose with near-normal blood sugar) - You have another mental health condition such as bipolar disorder, psychosis, or active substance abuse - You have significant cardiovascular disease, epilepsy, or a family history of sudden cardiac death - You are pregnant or breastfeeding - You are allergic to methylphenidate or lisdexamfetamine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALparental training in behavior management

Parental training in behavior management - online group sessions (4-6 families within group) with trained specialist, 10 once-weekly sessions. To continue to pharmacotherapy, the parents/legal guardians are required to participate in at least 8 out of 10 sessions.

DRUGLisdexamfetamine

Once-daily pharmacotherapy with lisdexamfetamine (608137-32-2, SUB32146), administered orally, for a duration of 6 months with initial dose of 30mg and dose optimization for 5-7 weeks (visits after 1st, 3rd and 5th week of therapy to adjust dose, in 20mg steps).

DRUGMethylphenidate

Once-daily pharmacotherapy with methylphenidate (prolonged-release tablet, 298-59-9, SUB03254MIG), administered orally, for a duration of 6 months with initial of 18mg dose optimization for 5-7 weeks (visits after 1st, 3rd and 5th week of therapy to adjust dose, in 18mg steps).

Locations(1)

Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05957055

Related Trials

The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France

NCT0721112621 locations

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

NCT0633413358 locations

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults

NCT07222137107 locations

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

NCT07222332132 locations

Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature

NCT073863401 location