PMID- 36282771
OWN - NLM
STAT- MEDLINE
DCOM- 20221027
LR  - 20221222
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Linking)
VI  - 32
IP  - 8
DP  - 2022 Oct
TI  - 26-Week Open-Label Extension Study Evaluating the Safety and Tolerability of 
      Flexible Doses of Oral Ziprasidone in Children and Adolescents with Bipolar I 
      Disorder (Most Recent Episode Manic).
PG  - 453-458
LID - 10.1089/cap.2022.0030 [doi]
AB  - Objective: To describe the longer-term effectiveness, safety, and tolerability of 
      open-label ziprasidone in children and adolescents with bipolar I disorder 
      (BD-I). Methods: A subset of 23 participants aged 10-17 years, who were 
      previously treated in a multi-site, 4-week randomized controlled trial received 
      open-label ziprasidone (20-80 mg twice a day) for up to 26 weeks. Results: The 
      most common adverse events (AEs) were fatigue (30%), somnolence (17%), and nausea 
      (13%). Effects on weight, body mass index, and metabolic parameters (glucose, 
      cholesterol, and triglycerides) were minimal. No participant had a 
      Fridericia-corrected QT interval >/= 460 msec or a change from baseline of >/=60 
      msec, and there were no cardiac-related AEs. Both the participants who continued 
      ziprasidone and those who initiated ziprasidone in the open-label extension 
      showed improvements in their symptoms of mania. Conclusions: The overall findings 
      of the study are consistent with the accumulating knowledge on the safety profile 
      of ziprasidone in the acute and long-term treatment of children and adolescents 
      with BD-I, in the midst of a manic episode. ClinicalTrial.gov ID: NCT03768726.
FAU - Atkinson, Sarah
AU  - Atkinson S
AD  - Psychiatry, Child and Adolescent Psychiatry, Finger Lakes Clinical Research, 
      Rochester, New York, USA.
FAU - Bachinsky, Mary
AU  - Bachinsky M
AD  - Clinical Development and Operations, Pfizer, Inc., Groton, Connecticut, USA.
FAU - Raiter, Yaron
AU  - Raiter Y
AD  - Clinical Development, GE Healthcare, Eindhoven, The Netherlands.
FAU - Abreu, Paula
AU  - Abreu P
AD  - Global Biometrics and Data Management, Pfizer, Inc., New York, New York, USA.
FAU - Ianos, Claudia
AU  - Ianos C
AD  - Worldwide Medical and Safety, Pfizer AG, Zurich, Switzerland.
FAU - Chappell, Phillip
AU  - Chappell P
AUID- ORCID: 0000-0001-5124-6236
AD  - Clinical Development and Operations, Pfizer, Inc., Groton, Connecticut, USA.
FAU - Findling, Robert L
AU  - Findling RL
AD  - Department of Psychiatry, Virginia Commonwealth University, Richmond, Virginia, 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03768726
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 6UKA5VEJ6X (ziprasidone)
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Triglycerides)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - Child
MH  - Adolescent
MH  - Humans
MH  - *Bipolar Disorder/diagnosis
MH  - Mania
MH  - *Antipsychotic Agents/adverse effects
MH  - Triglycerides
MH  - Glucose
MH  - Treatment Outcome
OTO - NOTNLM
OT  - bipolar I disorder
OT  - children and adolescents
OT  - mania
OT  - open label
OT  - safety
OT  - ziprasidone
EDAT- 2022/10/26 06:00
MHDA- 2022/10/28 06:00
CRDT- 2022/10/25 13:13
PHST- 2022/10/25 13:13 [entrez]
PHST- 2022/10/26 06:00 [pubmed]
PHST- 2022/10/28 06:00 [medline]
AID - 10.1089/cap.2022.0030 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2022 Oct;32(8):453-458. doi: 
      10.1089/cap.2022.0030.