Stepped Treatment for Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior: A Randomized, Controlled Trial of Adjunctive Risperidone, Divalproex Sodium, or Placebo After Stimulant Medication Optimization.

Autor: Blader JC; University of Texas Health Science Center, San Antonio. Electronic address: blader@uthscsa.edu., Pliszka SR; University of Texas Health Science Center, San Antonio., Kafantaris V; Zucker Hillside Hospital and the Feinstein Institute for Medical Research, Manhasset, New York., Foley CA; Cohen Children's Medical Center of New York, Divisions of Northwell Health, Manhasset, New York., Carlson GA; Renaissance School of Medicine, Stony Brook University, New York., Crowell JA; Renaissance School of Medicine, Stony Brook University, New York., Bailey BY; University of Texas Health Science Center, San Antonio., Sauder C; Adams Clinical, Watertown, Massachusetts., Daviss WB; Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire., Sinha C; Renaissance School of Medicine, Stony Brook University, New York., Matthews TL; University of Texas Health Science Center, San Antonio., Margulies DM; Renaissance School of Medicine, Stony Brook University, New York.
Jazyk: angličtina
Zdroj: Journal of the American Academy of Child and Adolescent Psychiatry [J Am Acad Child Adolesc Psychiatry] 2021 Feb; Vol. 60 (2), pp. 236-251. Date of Electronic Publication: 2020 Jan 30.
DOI: 10.1016/j.jaac.2019.12.009
Abstrakt: Objective: Stimulant medications are the most prevalent first-line pharmacotherapy for attention-deficit/hyperactivity disorder, but children with aggressive behavior often receive multiagent treatment. There is sparse evidence for the benefits of adjunctive medications when stimulant monotherapy provides inadequate benefit for aggressive behavior, yet the adverse effects of common adjuncts are well established. This study compared the efficacy in reducing aggressive behavior of risperidone (RISP), divalproex sodium (DVPX), and placebo (PBO) added to stimulant medication among childrenwhose symptoms persisted after individually optimized stimulant treatment.
Method: This trial enrolled 6- to 12-year-old with attention-deficit/hyperactivity disorder, a disruptive disorder, significant aggressive behavior, and prior stimulant treatment. Open, systematically titrated stimulant treatment identified patients with inadequate reductions in aggressive behavior, who were then randomly assigned to receive adjunctive RISP, DVPX, or PBO under double-blinded conditions for 8 weeks. Family-based behavioral treatment was offered throughout the trial. The primary outcome was the parent-completed Retrospective Modified Overt Aggression Scale.
Results: Participants included 175 children (mean [SD] age 9.48 [2.04] years, 19% female). Of participants, 151 completed the stimulant optimization phase, with aggression remitting among 96 (63%), and 45 were randomly assigned to adjunctive treatment groups. The adjunctive RISP group showed greater reductions in aggression ratings than the PBO group (least squares means difference [ΔLSM], -2.33; 95% CI, -3.83 to -0.82; effect size [ES], -1.32), as did the DVPX group (ΔLSM, -1.60; 95% CI, -3.18 to -0.03; ES, -0.91). Mean standardized body mass index scores increased more among RISP-treated participants than participants receiving PBO (ΔLSM, 1.54; 95% CI, 0.68 to 2.40; ES, 0.58).
Conclusion: High response rate during the trial's open stimulant optimization phase suggests that rigorous titration of stimulant medication and concurrent behavioral therapy may avert the need for additional medications. Among nonremitters, RISP and DVPX were efficacious adjunctive treatments, although RISP was associated with weight gain.
Clinical Trial Registration Information: Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study); https://www.clinicaltrials.gov; NCT00794625.
(Copyright © 2020 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE