Phase 2 ADHD Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Be between 8 and 16.5 years old at the time of joining the study
- Have been diagnosed with Type 1 diabetes (T1D) based on blood sugar tests, specific diabetes-related antibodies in the blood, and/or low levels of a substance called C-peptide
- Have had Type 1 diabetes for at least 12 months before joining the study
- Be currently treating their diabetes with an intensive insulin therapy programme (multiple daily injections or a pump adjusted based on meals and activity)
- Have a confirmed diagnosis of ADHD (Attention Deficit Hyperactivity Disorder) made by a psychiatrist or other authorised professional, using recognised diagnostic guidelines
- Be a Polish citizen with Polish health insurance
Who may not be able to join:
- Children whose diabetes appears to be in a partial remission phase (using very little insulin and having well-controlled blood sugar levels in the past 3 months)
- Children whose blood sugar control has been very poor over the past year, with an average HbA1c (a measure of long-term blood sugar) of 12% or higher
- Children with an intellectual disability or other condition that would prevent them from taking part in or following the trial's treatment plan
- Children with a significant, clinically recognised heart or blood vessel condition
- Children diagnosed with certain other mental health conditions, such as bipolar disorder, schizophrenia, psychotic disorders, or substance misuse
- Children with a known allergy or sensitivity to the trial medications methylphenidate or lisdexamphetamine
- Children or families who cannot communicate fully in Polish
- Children who do not permanently live in Poland
- Children with certain medical conditions that are listed as reasons not to use the trial medications, including: high blood pressure (stage 2 or above), a family history of sudden heart-related deaths or irregular heart rhythms in relatives under 40, certain eye conditions (glaucoma or raised eye pressure), a history of suicide attempts or current thoughts of suicide, a condition called oppositional defiant disorder, chronic motor tics or Tourette syndrome, pregnancy or breastfeeding, being significantly underweight or very short for their age (at or below the 3rd percentile), epilepsy, a tumour of the adrenal gland (pheochromocytoma), substance misuse or a positive drug test, or long-term use of sedating medications such as older antihistamines (confirm with trial site)
- Families who are unable or unwilling to visit the trial centre as required — particularly to collect medication adjustments approximately 4–5 times over a 6–8 week period, each within a 2–3 day window
- Children who, in their doctor's opinion, may have difficulty completing the trial or whose health could be put at risk by participating
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Agnieszka Butwicka, A/Prof, Department of Biostatistics and Translational Medicine, Medical University of Lodz
Phone: +46 72 326 66 31
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in ADHD symptom scores on the "inattention" scale of the Conners 3 questionnaire; Change in ADHD symptom scores on the "hyperactivity/impulsivity" scale of the Conners 3 questionnaire; The number of adverse events - methylphenidate arm; The frequency of adverse events - methylphenidate arm; The number of adverse events - lisdexamphetamine arm; The frequency of adverse events - lisdexamphetamine arm
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.