title: An open-label trial of risperidone in children and adolescents with severe mood dysregulation.
abstract: OBJECTIVE
  The diagnosis and treatment of youth with severe nonepisodic irritability and hyperarousal, a syndrome defined as severe mood dysregulation (SMD), has been the focus of increasing concern and debate among clinicians and researchers. Our main objective was to assess the effectiveness of risperidone for youths with SMD.
  
  
  METHODS
  An 8-week open label trial with risperidone was conducted. We extensively assessed 97 subjects with semistructured and clinical interviews and enrolled 21 patients in the study. Risperidone was titrated from 0.5 to 3 mg/day in the first 2 weeks. Evaluations were performed at baseline and weeks 2, 4, 6, and 8. Clinical outcome measures were (1) Aberrant Behavior Checklist-Irritability Subscale, (2) Clinical Global Impressions, and (3) severity of co-morbid conditions.
  
  
  RESULTS
  We found a significant reduction of the Aberrant Behavior Checklist-Irritability scores during the trial after risperidone use (p < 0.001). The scores at week 2 (mean = 12.03; standard error [SE] = 2.94), week 4 (mean = 15.48; SE = 2.93), week 6 (mean = 12.29; SE = 2.86), and week 8 (mean = 11.28; SE = 3.06) were significantly reduced compared with the baseline mean score (mean = 25.89; SE = 2.76) (p < 0.001). We also found an improvement in attention-deficit/hyperactivity disorder, depression, and global functioning (p < 0.001).
  
  
  CONCLUSIONS
  Risperidone was effective in reducing irritability in SMD youth. To the best of our knowledge, this is the first psychopharmacological trial in this group of patients with positive results. Further randomized, controlled studies are needed.
authors.affiliation: Juvenile Bipolar Disorder Outpatient Program (ProCAB), Division of Child and Adolescent Psychiatry, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil .
authors.forename: Fernanda Valle
authors.initials: FV
authors.lastname: Krieger
authors.forename: Gabriel Ferreira
authors.initials: GF
authors.lastname: Pheula
authors.forename: Roberta
authors.initials: R
authors.lastname: Coelho
authors.forename: Thamis
authors.initials: T
authors.lastname: Zeni
authors.forename: Silzá
authors.initials: S
authors.lastname: Tramontina
authors.forename: Cristian Patrick
authors.initials: CP
authors.lastname: Zeni
authors.forename: Luis Augusto
authors.initials: LA
authors.lastname: Rohde
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects*; D008297:Male; D019964:Mood Disorders / Q000188:drug therapy* / Q000503:physiopathology; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone