PMID- 25210452
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140911
LR  - 20211021
IS  - 1176-6328 (Print)
IS  - 1178-2021 (Electronic)
IS  - 1176-6328 (Linking)
VI  - 10
DP  - 2014
TI  - The safety and effectiveness of open-label extended-release carbamazepine in the 
      treatment of children and adolescents with bipolar I disorder suffering from a 
      manic or mixed episode.
PG  - 1589-97
LID - 10.2147/NDT.S68951 [doi]
AB  - OBJECTIVE: To assess the safety and effectiveness of open-label treatment with 
      extended-release carbamazepine (ERC) in pediatric subjects suffering from bipolar 
      I disorder. METHOD: Medically healthy youths aged 10-17 years suffering from an 
      acute manic or mixed episode were eligible. After screening for study 
      eligibility, the youths began a 5-week titration period in which doses of ERC 
      were adjusted in order to optimize benefit whilst minimizing adverse events, at 
      doses between 200-1,200 mg/day. Thereafter, subjects could continue to receive 
      treatment during a subsequent 21-week period. Safety measures included 
      spontaneously reported adverse events (AEs) and laboratory assessments. The 
      primary efficacy measure was the Young Mania Rating Scale (YMRS). RESULTS: A 
      total of 60 children (ages 10-12) and 97 adolescents (ages 13-17), with an 
      overall average age of 13.4 years (standard deviation [SD] 2.0 years) received 
      ERC. The mean duration of study participation was 109.6 days (SD 70.2 days), with 
      66 (42%) completing the entire study. At end of study participation (end point), 
      the most prevalent dose of ERC was 1,200 mg: 31.7% of children and 24.7% of 
      adolescents reached the 1,200 mg dose. The YMRS decreased from a mean of 28.6 (SD 
      6.2) at baseline to a mean of 13.8 (SD 9.4) (P<0.0001) at end point. A total of 
      26 subjects discontinued study participation because of AEs, the most common of 
      which were rash (n=6), white blood cell count decreased (n=5), nausea (n=3), and 
      vomiting (n=3). No deaths were reported. The most commonly reported AEs were 
      headache (n=41), somnolence (n=30), nausea (n=22), dizziness (n=21), and fatigue 
      (n=19). CONCLUSIONS: Open-label administration of ERC might be a safe and 
      effective intervention in this subject population. More definitive studies are 
      warranted.
FAU - Findling, Robert L
AU  - Findling RL
AD  - Division of Child and Adolescent Psychiatry, Department of Psychiatry and 
      Behavioral Sciences, Johns Hopkins University, MD, USA ; Kennedy Krieger 
      Institute, Baltimore, MD, USA.
FAU - Ginsberg, Lawrence D
AU  - Ginsberg LD
AD  - Red Oak Psychiatry Associates, PA, Houston, TX, USA.
LA  - eng
PT  - Journal Article
DEP - 20140827
PL  - New Zealand
TA  - Neuropsychiatr Dis Treat
JT  - Neuropsychiatric disease and treatment
JID - 101240304
PMC - PMC4156006
OTO - NOTNLM
OT  - adolescents
OT  - bipolar disorder
OT  - carbamazpine
OT  - children
OT  - treatment
EDAT- 2014/09/12 06:00
MHDA- 2014/09/12 06:01
PMCR- 2014/08/27
CRDT- 2014/09/12 06:00
PHST- 2014/09/12 06:00 [entrez]
PHST- 2014/09/12 06:00 [pubmed]
PHST- 2014/09/12 06:01 [medline]
PHST- 2014/08/27 00:00 [pmc-release]
AID - ndt-10-1589 [pii]
AID - 10.2147/NDT.S68951 [doi]
PST - epublish
SO  - Neuropsychiatr Dis Treat. 2014 Aug 27;10:1589-97. doi: 10.2147/NDT.S68951. 
      eCollection 2014.