A randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AR19, a manipulation-resistant formulation of amphetamine sulfate, in adults with attention-deficit/hyperactivity disorder
The Journal of Clinical Psychiatry Aug 29, 2021
Faraone SV, Childress A, Caras S, et al. - AR19 was identified as efficacious on all endpoints in the treatment of attention-deficit/hyperactivity disorder (ADHD) and was generally well tolerated.
This randomized, double-blind, placebo-controlled, fixed-dose, forced titration, multicenter trial involved 320 participants.
Participants were titrated to 20 mg or 40 mg AR19 daily or placebo.
Compared with placebo, the least squares mean treatment differences were −7.2 (−11.3 to −3.1) and −7.3 (−11.4 to −3.2) for the AR19 20-mg group and the AR19 40-mg group, respectively.
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