PMID- 35394365
OWN - NLM
STAT- MEDLINE
DCOM- 20220421
LR  - 20220511
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Linking)
VI  - 32
IP  - 3
DP  - 2022 Apr
TI  - Efficacy, Safety, and Tolerability of Flexibly Dosed Ziprasidone in Children and 
      Adolescents with Mania in Bipolar I Disorder: A Randomized Placebo-Controlled 
      Replication Study.
PG  - 143-152
LID - 10.1089/cap.2021.0121 [doi]
AB  - Objective: To evaluate the acute efficacy, safety, and tolerability of flexibly 
      dosed ziprasidone in children and adolescents with Bipolar I Disorder (BD-I). 
      Methods: Participants, 10-17 years of age, meeting The Diagnostic and Statistical 
      Manual of Mental Disorders, 5th edition criteria, were randomized 1:1 in a 4-week 
      double-blind (DB) study, to receive ziprasidone (20-80 mg/twice a day) or 
      placebo. Some were then enrolled in a 26-week open-label extension (OLE) study. 
      The primary efficacy measure was the Young Mania Rating Scale (YMRS) total score. 
      Results: A total of 171 participants entered this randomized DB study and 23 
      continued into the OLE study. The mean (SD) age of the combined sample was 13.4 
      (2.1) years, 44.4% were male, and 66.7% were white. The demographic 
      characteristics of participants who received ziprasidone (n = 86) or placebo 
      (n = 85) were similar. The primary objective was met: the mean difference for 
      ziprasidone versus placebo in the YMRS total score was -4.23 (95% confidence 
      interval: -7.14 to -1.32; p = 0.005) indicating an effect size of 0.58. The most 
      common adverse events (AEs) in the ziprasidone group were somnolence (31.4%), 
      fatigue (22.1%), and nausea (14%). The mean Fridericia-corrected QT interval 
      (QTcF) intervals in the ziprasidone group were moderately prolonged relative to 
      the placebo group at all study visits. No participants had QTcF intervals 
      >/=480 msec or an increase from baseline >/=60 msec. No AEs indicative of QT 
      prolongation occurred. Weight, body mass index (BMI), and BMI z-scores, and 
      metabolic measures were similar in both treatment groups. The data from the OLE 
      study will be reported separately. Conclusions: Ziprasidone was effective in 
      children and adolescents with BD-I in a manic episode, replicating the results of 
      a previous study with a similar design (Findling et al. 2013). Overall, 
      ziprasidone was safe and well tolerated with no meaningful effects on weight or 
      metabolic parameters. Trial registration: ClinicalTrials.gov. NCT02075047 and 
      NCT03768726.
FAU - Findling, Robert L
AU  - Findling RL
AD  - Department of Psychiatry, Virginia Commonwealth University, Richmond, Virginia, 
      USA.
FAU - Atkinson, Sarah
AU  - Atkinson S
AD  - Finger Lakes Clinical Research, Rochester, New York, USA.
FAU - Bachinsky, Mary
AU  - Bachinsky M
AD  - Pfizer, Inc., Groton, Connecticut, USA.
FAU - Raiter, Yaron
AU  - Raiter Y
AD  - Viatris, Inc., Amstelveen, Netherlands.
FAU - Abreu, Paula
AU  - Abreu P
AD  - Pfizer, Inc., New York, New York, USA.
FAU - Ianos, Claudia
AU  - Ianos C
AD  - Pfizer AG, Zurich, Switzerland.
FAU - Chappell, Phillip
AU  - Chappell P
AUID- ORCID: 0000-0001-5124-6236
AD  - Pfizer, Inc., Groton, Connecticut, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02075047
SI  - ClinicalTrials.gov/NCT03768726
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220407
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
MH  - *Bipolar Disorder/diagnosis
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Mania
MH  - Piperazines
MH  - Psychiatric Status Rating Scales
MH  - Thiazoles
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Bipolar I Disorder
OT  - children and adolescents
OT  - mania
OT  - ziprasidone
EDAT- 2022/04/09 06:00
MHDA- 2022/04/22 06:00
CRDT- 2022/04/08 12:10
PHST- 2022/04/09 06:00 [pubmed]
PHST- 2022/04/22 06:00 [medline]
PHST- 2022/04/08 12:10 [entrez]
AID - 10.1089/cap.2021.0121 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2022 Apr;32(3):143-152. doi: 
      10.1089/cap.2021.0121. Epub 2022 Apr 7.