150
Participants
Start Date
February 5, 2024
Primary Completion Date
December 1, 2027
Study Completion Date
December 1, 2027
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.
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).
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).
RECRUITING
Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz, Lodz
Medical University of Silesia
OTHER
Medical University of Gdansk
OTHER
Institute of Medical Sciences of the University of Opole
UNKNOWN
Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz
UNKNOWN
Medical University of Lodz
OTHER