A prospective open-label trial of lamotrigine monotherapy in children and adolescents with bipolar disorder.
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.
Biederman
Joseph
J
Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, MA, USA. jbierderman@partners.org
Joshi
Gagan
G
Mick
Eric
E
Doyle
Robert
R
Georgiopoulos
Anna
A
Hammerness
Paul
P
Kotarski
Meghan
M
Williams
Courtney
C
Wozniak
Janet
J
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*
D000927:Anticonvulsants; D014227:Triazines; D000077213:Lamotrigine