A prospective open-label trial of extended-release carbamazepine monotherapy in children with bipolar disorder.

Abstract

OBJECTIVE:

The aim of this study was to evaluate the safety and efficacy of extended release carbamazepine (CBZ-ER) monotherapy in the treatment of pediatric bipolar disorder (BD).

METHOD:

This was an 8-week, open-label, prospective trial of CBZ-ER monotherapy (788 +/- 252 mg/day) to assess the effectiveness and tolerability of this compound in treating pediatric bipolar spectrum disorders. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale, Children's Depression Rating Scale, and Brief Psychiatric Rating Scale. Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis.

RESULTS:

Of the 27 participating children with BD, 16 (59.%) completed the study. CBZ-ER treatment was associated with statistically significant, but modest, levels of improvement in mean YMRS scores (-10.1 +/- 10.2, p < 0.001) with end-point mean YMRS score (21.8 +/- 12.2) suggesting a lack of complete resolution of mania. CBZ-ER treatment also resulted in significant improvement in the severity of depressive, attention-deficit/hyperactivity disorder, and psychotic symptoms. With the exception of 2 participants who discontinued due to skin rash, CBZ-ER was well tolerated with marginal increase in body weight (0.8 +/- 2.5 kg, p = 0.04) and was not associated with any abnormal changes in laboratory parameters.

CONCLUSIONS:

Open-label CBZ-ER treatment was beneficial for the treatment of BD in children. Future controlled trials are warranted.

• Authors: Gagan Joshi, Janet Wozniak, Eric Mick, Robert Doyle, Paul Hammerness, Anna Georgiopoulos, Meghan Kotarski, Megan Aleardi, Courtney Williams, Sarah Walls, Joseph Biederman
• Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol) Vol. 20 Issue 1 Pg. 7-14 (Feb 2010) ISSN: 1557-8992 [Electronic] United States
• PMID: 20166791 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antimanic Agents
• Delayed-Action Preparations
• Carbamazepine

Topics

• Antimanic Agents (administration & dosage, adverse effects)
• Attention Deficit Disorder with Hyperactivity (drug therapy)
• Bipolar Disorder (drug therapy, psychology)
• Body Weight (drug effects)
• Carbamazepine (administration & dosage, adverse effects)
• Child
• Comorbidity
• Delayed-Action Preparations (administration & dosage)
• Depression (drug therapy)
• Drug Administration Schedule
• Drug-Related Side Effects and Adverse Reactions (chemically induced)
• Exanthema (chemically induced)
• Female
• Humans
• Male
• Massachusetts
• Outpatients
• Prospective Studies
• Psychiatric Status Rating Scales
• Treatment Outcome