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

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 5, 2024

Primary Completion Date

December 1, 2027

Study Completion Date

December 1, 2027

Conditions
Attention Deficit Disorder with HyperactivityDiabetes 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).

Trial Locations (1)

91-738

RECRUITING

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

All Listed Sponsors
collaborator

Medical University of Silesia

OTHER

collaborator

Medical University of Gdansk

OTHER

collaborator

Institute of Medical Sciences of the University of Opole

UNKNOWN

collaborator

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

UNKNOWN

lead

Medical University of Lodz

OTHER