title: What does risperidone add to parent training and stimulant for severe aggression in child attention-deficit/hyperactivity disorder?
abstract: OBJECTIVE
  Although combination pharmacotherapy is common in child and adolescent psychiatry, there has been little research evaluating it. The value of adding risperidone to concurrent psychostimulant and parent training (PT) in behavior management for children with severe aggression was tested.
  
  
  METHODS
  One hundred sixty-eight children 6 to 12 years old (mean age 8.89 ± 2.01 years) with severe physical aggression were randomized to a 9-week trial of PT, stimulant (STIM), and placebo (Basic treatment; n = 84) or PT, STIM, and risperidone (Augmented treatment; n = 84). All had diagnoses of attention-deficit/hyperactivity disorder and oppositional-defiant disorder (n = 124) or conduct disorder (n = 44). Children received psychostimulant (usually Osmotic Release Oral System methylphenidate) for 3 weeks, titrated for optimal effect, while parents received PT. If there was room for improvement at the end of week 3, placebo or risperidone was added. Assessments included parent ratings on the Nisonger Child Behavior Rating Form (Disruptive-Total subscale was the primary outcome) and Antisocial Behavior Scale; blinded clinicians rated change on the Clinical Global Impressions scale.
  
  
  RESULTS
  Compared with Basic treatment (PT + STIM [44.8 ± 14.6 mg/day] + placebo [1.88 mg/day ± 0.72]), Augmented treatment (PT + STIM [46.1 ± 16.8 mg/day] + risperidone [1.65 mg/day ± 0.75]) showed statistically significant improvement on the Nisonger Child Behavior Rating Form Disruptive-Total subscale (treatment-by-time interaction, p = .0016), the Nisonger Child Behavior Rating Form Social Competence subscale (p = .0049), and Antisocial Behavior Scale Reactive Aggression subscale (p = .01). Clinical Global Impressions scores were substantially improved for the 2 groups but did not discriminate between treatments (Clinical Global Impressions-Improvement score ≤2, 70% for Basic treatment versus 79% for Augmented treatment). Prolactin elevations and gastrointestinal upset occurred more with Augmented treatment; other adverse events differed modestly from Basic treatment; weight gain in the Augmented treatment group was minor.
  
  
  CONCLUSIONS
  Risperidone provided moderate but variable improvement in aggressive and other seriously disruptive child behaviors when added to PT and optimized stimulant treatment. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study), URL: http://clinicaltrials.gov, unique identifier: NCT00796302.
authors.affiliation: The Ohio State University. Electronic address: aman.1@osu.edu.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Aman
authors.affiliation: University of Texas-Houston Medical School.
authors.forename: Oscar G
authors.initials: OG
authors.lastname: Bukstein
authors.affiliation: Stony Brook University.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Gadow
authors.affiliation: The Ohio State University.
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Arnold
authors.affiliation: University of Pittsburg School of Medicine.
authors.forename: Brooke S G
authors.initials: BS
authors.lastname: Molina
authors.affiliation: Case Western Reserve University.
authors.forename: Nora K
authors.initials: NK
authors.lastname: McNamara
authors.affiliation: Stony Brook University Medical Center.
authors.forename: E Victoria
authors.initials: EV
authors.lastname: Rundberg-Rivera
authors.affiliation: The Ohio State University.
authors.forename: Xiaobai
authors.initials: X
authors.lastname: Li
authors.affiliation: University of Pittsburg School of Medicine.
authors.forename: Heidi
authors.initials: H
authors.lastname: Kipp
authors.affiliation: Stony Brook University Medical Center.
authors.forename: Jayne
authors.initials: J
authors.lastname: Schneider
authors.affiliation: Nationwide Children's Hospital of Columbus.
authors.forename: Eric M
authors.initials: EM
authors.lastname: Butter
authors.affiliation: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Baker
authors.affiliation: Stony Brook University.
authors.forename: Joyce
authors.initials: J
authors.lastname: Sprafkin
authors.affiliation: The Ohio State University.
authors.forename: Robert R
authors.initials: RR
authors.lastname: Rice
authors.affiliation: University of Pittsburg School of Medicine.
authors.forename: Srihari S
authors.initials: SS
authors.lastname: Bangalore
authors.affiliation: The Ohio State University.
authors.forename: Cristan A
authors.initials: CA
authors.lastname: Farmer
authors.affiliation: The Ohio State University.
authors.forename: Adrienne B
authors.initials: AB
authors.lastname: Austin
authors.affiliation: The Ohio State University.
authors.forename: Kristin A
authors.initials: KA
authors.lastname: Buchan-Page
authors.affiliation: The Ohio State University.
authors.forename: Nicole V
authors.initials: NV
authors.lastname: Brown
authors.affiliation: The Ohio State University.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Hurt
authors.affiliation: The Ohio State University.
authors.forename: Sabrina N
authors.initials: SN
authors.lastname: Grondhuis
authors.affiliation: Johns Hopkins University.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
mesh_terms: D000374:Aggression / Q000187:drug effects / Q000523:psychology*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy / Q000628:therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000494:pharmacology*; D002648:Child; D003131:Combined Modality Therapy; D004357:Drug Synergism; D006801:Humans; D008297:Male; D010290:Parents / Q000193:education*; D018967:Risperidone / Q000008:administration & dosage / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D018967:Risperidone
keywords: disruptive behavior disorders; parent training; physical aggression; psychostimulants; risperidone