title: An open-label study of aripiprazole in children with a bipolar disorder.
abstract: OBJECTIVE
  The purpose of this open-label study was to describe the effectiveness of aripiprazole (APZ) in the treatment of children with bipolar disorders suffering from manic symptomatology.
  
  
  METHODS
  Symptomatic outpatients (Young Mania Rating Scale [YMRS] score ≥15) meeting strict, unmodified, Diagnostic and Statistical Manual of Mental Disorders, 4th edition, diagnostic symptom criteria for a bipolar disorder, ages 4-9 years, were eligible. Subjects were treated prospectively with flexible doses of APZ (maximum daily dose of 15 mg/day), for up to 16 weeks or until a priori response criteria were met. Outcome measures included the YMRS, Clinical Global Impressions Scale-Severity, Children's Global Assessment Scale (CGAS), and the Children's Depression Rating Scale-Revised (CDRS-R). A priori response criteria consisted of 3 of 4 consecutive weeks with (1) CDRS-R <29; (2) YMRS <10; and (3) CGAS >50.
  
  
  RESULTS
  Ninety-six children (62 males; mean age of 6.9 (SD = 1.7), received APZ for an average length of treatment of 12.5 (SD = 3.9) weeks. Significant improvements in YMRS, CDRS-R, CGAS, and Clinical Global Impressions Scale-Severity scores (p < 0.001) were noted at the end of study participation. Sixty of the subjects (62.5%) met a priori response criteria at study's end. The most common side effects noted were stomachache, increased appetite, and headache. Two subjects were removed from the study due to side effects [epistaxis (n = 1); akathisia (n = 1)]. Subjects experienced an average weight gain of 2.4 (SD = 1.9) kg.
  
  
  CONCLUSIONS
  APZ may be effective in the acute treatment of symptoms of children with bipolar illnesses.
authors.affiliation: Department of Psychiatry, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, Ohio 44106, USA. robert.findling@uhhospitals.org
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: Nora K
authors.initials: NK
authors.lastname: McNamara
authors.forename: Eric A
authors.initials: EA
authors.lastname: Youngstrom
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Stansbrey
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Frazier
authors.forename: Jacqui
authors.initials: J
authors.lastname: Lingler
authors.forename: Benjamin D
authors.initials: BD
authors.lastname: Otto
authors.forename: Christine A
authors.initials: CA
authors.lastname: Demeter
authors.forename: Brieana M
authors.initials: BM
authors.lastname: Rowles
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Calabrese
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy / Q000453:epidemiology; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D000697:Central Nervous System Stimulants / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D010045:Outpatients; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
chemical_list: D014150:Antipsychotic Agents; D000697:Central Nervous System Stimulants; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole