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.

Conditions

• Attention Deficit Disorder with Hyperactivity
• Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

parental 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.

DRUG

Lisdexamfetamine

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).

DRUG

Methylphenidate

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).

Sponsors & Collaborators

• Medical University of Silesia

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Institute of Medical Sciences of the University of Opole

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Medical University of Lodz

  lead OTHER

Principal Investigators

• Agnieszka Butwicka, A/Prof · Department of Biostatistics and Translational Medicine, Medical University of Lodz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

8 Years

Max Age

198 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-05

Primary Completion

2027-12-01

Completion

2027-12-01

Countries

• Poland

Study Locations