Actively Recruiting
Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes
Led by Medical University of Lodz · Updated on 2024-11-29
150
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
M
Medical University of Lodz
Lead Sponsor
M
Medical University of Silesia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 8 and 16.5 years at study entry
- Diagnosis of Type 1 Diabetes confirmed by clinical features, autoantibodies, or low C-peptide levels, meeting established diabetes criteria
- Type 1 Diabetes diagnosed at least 12 months before joining the study
- Receiving functional intensive insulin therapy for Type 1 Diabetes
- Diagnosis of ADHD according to DSM-5 or recognized equivalent confirmed by a psychiatrist or authorized person
- Polish citizenship and valid Polish health insurance
You will not qualify if you...
- Daily insulin dose less than 0.3 j/kg with HbA1c 6.5% or lower in the last 3 months (clinical partial remission of T1D)
- Poor glycemic control with mean HbA1c over 12% in the past year (excluding diagnosis time)
- Intellectual or other disabilities that prevent trial participation or following the treatment plan
- Significant cardiovascular diseases like heart defects or advanced vascular atherosclerosis
- Other mental illnesses preventing participation, such as bipolar disorder, schizophrenia, psychotic disorders, or substance abuse
- Allergy or hypersensitivity to methylphenidate or lisdexamfetamine
- Language barrier preventing psychological consultation in Polish
- Lack of permanent residence in Poland
- Contraindications to study drugs including documented hypertension stage 2 or higher, family history of sudden cardiac death under age 40, glaucoma or high eye pressure, suicide risk, oppositional defiant disorder, chronic motor tics or Tourette syndrome, pregnancy or breastfeeding, short stature, underweight below 3rd percentile, epilepsy, pheochromocytoma, substance abuse or positive drug tests, long-term sedative use
- Inability or unwillingness of parents/legal guardians to attend specified trial visits, especially for drug pick-up during dose adjustments
- Any other reasons judged by the physician that could hinder continuous participation or cause harm to the participant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz
Lodz, Łódź Voivodeship, Poland, 91-738
Actively Recruiting
Research Team
A
Agnieszka Butwicka, A/Prof
CONTACT
A
Arkadiusz Michalak, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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