OBJECTIVE: The aim of this preliminary pilot study was to investigate the safety and efficacy of open-label nadolol as an adjunctive pharmacological treatment for aggression and/or inattention/overactivity in a developmentally delayed child, adolescent, and young adult population.

METHOD: Twelve subjects enrolled and completed (mean age 13.8 years, range 9 through 24) a 5-month, open, prospective protocol of nadolol (mean dose 109 mg, range 30 through 220 mg) with systematic baseline and outcome evaluations and weekly clinical assessment.

RESULTS: All subjects were developmentally delayed and most were cognitively delayed. Ten subjects (83%) showed clinical improvement while receiving nadolol. Significant improvements were noted on observer-rated overt categorical aggression, severity of illness, and global impressions of improvement. No significant effects were found for inattention/overactivity. Nadolol was well tolerated, with few side effects.

CONCLUSIONS: Overt categorical aggression presenting in developmentally delayed children, adolescents, and young adults may respond to nadolol treatment.