BUPROPION HYDROCHLORIDE IN ATTENTION-DEFICIT DISORDER WITH HYPERACTIVITY

Objective: This is a multisite, double-blind, placebo-controlled trial to determine the safety and efficacy of bupropion in the treatment of children with attention deficit disorder with hyperactivity (ADDH). M ethod: In a four-center, double-blind comparison of bupropion (n = 72) and placebo (n = 37), children aged 6 to 12 years meeting DSM-lll cri teria for ADDH were randomized to receive bupropion 3 to 6 mg/kg per d ay or placebo, administered twice daily, at 7 A.M. and 7 P.M. Measures of efficacy included the Conners Parent and Teacher Questionnaires (9 3-item, 39-item, and 10 item), Clinical Global Impressions Scales of S everity and Improvement, the Sternberg Short-Term Memory Task, and the Continuous Performance Test. Screen and posttreatment physical examin ations, electrocardiograms, electroencephalograms, and clinical labora tory evaluations were performed. Height, weight, and vital signs were measured and adverse experiences were assessed weekly. Results: A sign ificant treatment effect, apparent as early as day 3, was present for both conduct problems and hyperactivity on the Conners 10-item and 39- item teacher's checklist, and at day 28 for conduct problems and restl ess-impulsive behavior on the 93-item parent questionnaire. Findings w ere of smaller magnitude for parent ratings than teacher ratings. Sign ificant treatment effects were present on both the Continuous Performa nce Test and memory retrieval test. Effect sizes of bupropion/placebo differences for teacher and parent ratings in this study were somewhat smaller than for standard stimulant drugs used to treat ADDH. Bupropi on appeared to be well tolerated in most children. Dermatological reac tions were twice as frequent in the drug group as the placebo group, w ith four reactions involving rash and urticaria that were serious enou gh to require discontinuation of medication. Conclusions: Bupropion ma y be a useful addition to available treatments for ADDH. Comparative t rials with such standard drugs as methylphenidate are warranted to det ermine the relative clinical merits of bupropion.