PMID- 24111980
OWN - NLM
STAT- MEDLINE
DCOM- 20140526
LR  - 20220317
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 23
IP  - 8
DP  - 2013 Oct
TI  - Efficacy, long-term safety, and tolerability of ziprasidone in children and 
      adolescents with bipolar disorder.
PG  - 545-57
LID - 10.1089/cap.2012.0029 [doi]
AB  - OBJECTIVE: The purpose of this study was to evaluate the short- and long-term 
      efficacy and safety of ziprasidone in children and adolescents with bipolar I 
      disorder. METHODS: Subjects 10-17 years of age with a manic or mixed episode 
      associated with bipolar I disorder participated in a 4 week, randomized, 
      double-blind, placebo-controlled multicenter trial (RCT) followed by a 26 week 
      open-label extension study (OLE). Subjects were randomized 2:1 to initially 
      receive flexible-dose ziprasidone (40-160 mg/day, based on weight) or placebo. 
      Primary outcome was the change in Young Mania Rating Scale (YMRS) scores from 
      baseline. Safety assessments included weight and body mass index (BMI), adverse 
      events (AEs), vital signs, laboratory measures, electrocardiograms, and movement 
      disorder ratings. RESULTS: In the RCT, 237 subjects were treated with ziprasidone 
      (n=149; mean age, 13.6 years) or placebo (n=88; mean age, 13.7 years). The 
      estimated least squares mean changes in YMRS total (intent-to-treat population) 
      were -13.83 (ziprasidone) and -8.61 (placebo; p=0.0005) at RCT endpoint. The most 
      common AEs in the ziprasidone group were sedation (32.9%), somnolence (24.8%), 
      headache (22.1%), fatigue (15.4%), and nausea (14.1%). In the OLE, 162 subjects 
      were enrolled, and the median duration of treatment was 98 days. The mean change 
      in YMRS score from the end of the RCT to the end of the OLE (last observation 
      carried forward) was -3.3 (95% confidence interval, -5.0 to -1.6). The most 
      common AEs were sedation (26.5%), somnolence (23.5%), headache (22.2%), and 
      insomnia (13.6%). For both the RCT and the OLE, no clinically significant mean 
      changes in movement disorder scales, BMI z-scores, liver enzymes, or fasting 
      lipids and glucose were observed. One subject on ziprasidone in the RCT and none 
      during the OLE had Fridericia-corrected QT interval (QTcF) >/= 460 ms. CONCLUSION: 
      These results demonstrate that ziprasidone is efficacious for treating children 
      and adolescents with bipolar disorder. Ziprasidone was generally well tolerated 
      with a neutral metabolic profile. CLINICAL TRIALS REGISTRY: NCT00257166 and 
      NCT00265330 at ClinicalTrials.gov.
FAU - Findling, Robert L
AU  - Findling RL
AD  - 1 Department of Child and Adolescent Psychiatry, Johns Hopkins University and the 
      Kennedy Krieger Institute , Baltimore, Maryland.
FAU - Cavus, Idil
AU  - Cavus I
FAU - Pappadopulos, Elizabeth
AU  - Pappadopulos E
FAU - Vanderburg, Douglas G
AU  - Vanderburg DG
FAU - Schwartz, Jeffrey H
AU  - Schwartz JH
FAU - Gundapaneni, Balarama K
AU  - Gundapaneni BK
FAU - DelBello, Melissa P
AU  - DelBello MP
LA  - eng
SI  - ClinicalTrials.gov/NCT00257166
SI  - ClinicalTrials.gov/NCT00265330
GR  - UL1 TR000077/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131010
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - 0 (Thiazoles)
RN  - 6UKA5VEJ6X (ziprasidone)
SB  - IM
MH  - Adolescent
MH  - Antipsychotic Agents/*adverse effects/*therapeutic use
MH  - Bipolar Disorder/*drug therapy
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Piperazines/*adverse effects/*therapeutic use
MH  - Thiazoles/*adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC3804078
EDAT- 2013/10/12 06:00
MHDA- 2014/05/27 06:00
PMCR- 2014/10/01
CRDT- 2013/10/12 06:00
PHST- 2013/10/12 06:00 [entrez]
PHST- 2013/10/12 06:00 [pubmed]
PHST- 2014/05/27 06:00 [medline]
PHST- 2014/10/01 00:00 [pmc-release]
AID - 10.1089/cap.2012.0029 [pii]
AID - 10.1089/cap.2012.0029 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 
      10.1089/cap.2012.0029. Epub 2013 Oct 10.