A prospective open-label trial of lamotrigine monotherapy in children and adolescents with bipolar disorder.

Abstract

AIM:

To evaluate the safety and efficacy of lamotrigine monotherapy as an acute treatment of bipolar mood elevation in children with bipolar spectrum disorders.

METHOD:

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: Joseph Biederman, Gagan Joshi, Eric Mick, Robert Doyle, Anna Georgiopoulos, Paul Hammerness, Meghan Kotarski, Courtney Williams, Janet Wozniak
• Journal: CNS neuroscience & therapeutics (CNS Neurosci Ther) Vol. 16 Issue 2 Pg. 91-102 (Apr 2010) ISSN: 1755-5949 [Electronic] England
• PMID: 20415838 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Anticonvulsants
• Triazines
• Lamotrigine

Topics

• Adolescent
• Anticonvulsants (therapeutic use)
• Bipolar Disorder (drug therapy)
• Child
• Drug Administration Schedule
• Evaluation Studies as Topic
• Female
• Humans
• Lamotrigine
• Male
• Pediatrics
• Prospective Studies
• Psychiatric Status Rating Scales
• Treatment Outcome
• Triazines (therapeutic use)