title: A prospective open-label trial of lamotrigine monotherapy in children and adolescents with bipolar disorder.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of lamotrigine monotherapy as an acute treatment of bipolar mood elevation in children with bipolar spectrum disorders.
  
  
  METHODS
  This was a 12-week, open-label, prospective trial of lamotrigine monotherapy to assess the effectiveness and tolerability of this compound in treating pediatric bipolar disorder. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), Children's Depression Rating Scale (CDRS), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis.
  
  
  RESULTS
  Thirty-nine children with bipolar disorder (YMRS at entry: 31.6 +/- 5.5) were enrolled in the study and 22 (56%) completed the 12-week trial. Lamotrigine was slowly titrated to an average endpoint dose of 160.7 +/- 128.3 in subjects <12 years of age (N = 22) and 219.1 +/- 172.2 mg/day in children 12-17 years of age (N = 17). Treatment with lamotrigine was associated with statistically significant levels of improvement in mean YMRS scores (-14.9 +/- 9.7, P < 0.001) at endpoint. Lamotrigine treatment also resulted in significant improvement in the severity of depressive, attention-deficit/hyperactivity disorder (ADHD), and psychotic symptoms. Lamotrigine was generally well tolerated with marginal increase in body weight (47.0 +/- 18.0 kg vs. 47.2 +/- 17.9 kg, P= 0.6) and was not associated with abnormal changes in laboratory parameters. Several participants were discontinued due to skin rash; in all cases, the rash resolved shortly after discontinuation of treatment. No patient developed Steven Johnson syndrome.
  
  
  CONCLUSIONS
  Open-label lamotrigine treatment appears to be beneficial in the treatment of bipolar disorder and associated conditions in children. Future placebo-controlled, double-blind studies are warranted to confirm these findings.
authors.affiliation: Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, MA, USA. jbierderman@partners.org
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Gagan
authors.initials: G
authors.lastname: Joshi
authors.forename: Eric
authors.initials: E
authors.lastname: Mick
authors.forename: Robert
authors.initials: R
authors.lastname: Doyle
authors.forename: Anna
authors.initials: A
authors.lastname: Georgiopoulos
authors.forename: Paul
authors.initials: P
authors.lastname: Hammerness
authors.forename: Meghan
authors.initials: M
authors.lastname: Kotarski
authors.forename: Courtney
authors.initials: C
authors.lastname: Williams
authors.forename: Janet
authors.initials: J
authors.lastname: Wozniak
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D002648:Child; D004334:Drug Administration Schedule; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D010372:Pediatrics; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D014227:Triazines; D000077213:Lamotrigine