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


METHODS
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.
Joshi
Gagan
G
Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.
Wozniak
Janet
J
Mick
Eric
E
Doyle
Robert
R
Hammerness
Paul
P
Georgiopoulos
Anna
A
Kotarski
Meghan
M
Aleardi
Megan
M
Williams
Courtney
C
Walls
Sarah
S
Biederman
Joseph
J
D018692:Antimanic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D001835:Body Weight / Q000187:drug effects; D002220:Carbamazepine / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D015897:Comorbidity; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D003863:Depression / Q000188:drug therapy; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008404:Massachusetts; D010045:Outpatients; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D018692:Antimanic Agents; D003692:Delayed-Action Preparations; D002220:Carbamazepine