title: A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder.
abstract: OBJECTIVE
  To assess the effectiveness and tolerability of ziprasidone for treating pediatric mania.
  
  
  METHODS
  This was an eight-week, open-label, prospective study of ziprasidone monotherapy (57.3 +/- 33.9 mg/day) in 21 bipolar youth [manic, mixed, or bipolar not otherwise specified (NOS); 6-17 years old]. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs, weight monitoring, and laboratory analysis.
  
  
  RESULTS
  Fourteen of the 21 youth (67%) completed the study. Ziprasidone treatment was associated with clinically and statistically significant improvement in mean YMRS scores (-10.8 +/- 8.4, p < 0.0001) and 57% had a CGI-I <or=2 at endpoint. Ziprasidone was well tolerated with no statistically significant increase in body weight (0.6 +/- 0.4 kg, p = 0.2) or QTc interval (-3.7 +/- 4.7, p = 0.5).
  
  
  CONCLUSIONS
  Open-label ziprasidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder. Future placebo-controlled, double-blind studies are warranted.
authors: Massachusetts General Hospital, Pediatric Psychopharmacology Research Department, 32 Fruit Street, Yawkey Center for Outpatient Care-Yaw-6A, Boston, MA 02114, USA. jbiederman@partners.org
authors: Joseph
authors: J
authors: Biederman
authors: Eric
authors: E
authors: Mick
authors: Thomas
authors: T
authors: Spencer
authors: Meghan
authors: M
authors: Dougherty
authors: Megan
authors: M
authors: Aleardi
authors: Janet
authors: J
authors: Wozniak
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D001835:Body Weight / Q000187:drug effects; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D010372:Pediatrics; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D013844:Thiazoles / Q000627:therapeutic use*
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone