PMID- 32194443
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 1664-0640 (Print)
IS  - 1664-0640 (Electronic)
IS  - 1664-0640 (Linking)
VI  - 11
DP  - 2020
TI  - Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study 
      Data.
PG  - 61
LID - 10.3389/fpsyt.2020.00061 [doi]
LID - 61
AB  - Schizophrenia is a life-long mental disorder, affecting young adolescents to 
      elderly patients. Antipsychotic treatment is indicated for all patients with 
      schizophrenia, including the very young and old as well. Developmental issues in 
      the young and decline in organ functioning in the elderly could influence 
      reactions to the drug, and require different dosing regimens. The aim of the 
      present article was to examine the safety profile and dosing requirements in 
      adolescent (13 to less than 18) and elderly (65 and above) patients treated with 
      cariprazine. Data from two clinical studies (one pharmacokinetic pediatric study 
      and one phase III clinical trial) on 49 adolescent patients and 17 elderly 
      patients (65 years of age or above) treated with cariprazine was examined. Safety 
      measures included assessment of adverse events (AEs), clinical laboratory values, 
      physical examinations, extrapyramidal symptom (EPS)-, depression-, and 
      suicidality rating scales. Safety parameters were summarized using descriptive 
      statistics. Results indicate that cariprazine was generally safe and well 
      tolerated. Adverse events in the marginal age populations were comparable to the 
      adult population, except for less insomnia in the young and no reports of 
      akathisia in the elderly. Laboratory parameters, vital sign values and EEG 
      parameters were comparable to previously published data in the adult population. 
      In conclusion, cariprazine in the approved adult dose-range of 1.5-6 mg might be 
      a safe treatment option also in adolescent and elderly patients with 
      schizophrenia. Further studies are need to verify these preliminary findings.
CI  - Copyright (c) 2020 Szatmari, Barabassy, Harsanyi, Laszlovszky, Sebe, Gal, Shiragami 
      and Nemeth.
FAU - Szatmari, Balazs
AU  - Szatmari B
AD  - Department of Clinical Research, Gedeon Richter Plc., Budapest, Hungary.
FAU - Barabassy, Agota
AU  - Barabassy A
AD  - Department of Medical Affairs, Gedeon Richter Plc, Budapest, Hungary.
FAU - Harsanyi, Judit
AU  - Harsanyi J
AD  - Department of Clinical Research, Gedeon Richter Plc., Budapest, Hungary.
FAU - Laszlovszky, Istvan
AU  - Laszlovszky I
AD  - Department of Clinical Research, Gedeon Richter Plc., Budapest, Hungary.
FAU - Sebe, Barbara
AU  - Sebe B
AD  - Department of Medical Affairs, Gedeon Richter Plc, Budapest, Hungary.
FAU - Gal, Monika
AU  - Gal M
AD  - Department of Clinical Research, Gedeon Richter Plc., Budapest, Hungary.
FAU - Shiragami, Kazushi
AU  - Shiragami K
AD  - Department of Clinical Research and Development, Mitsubishi Tanabe Pharma 
      Corporation, Tokyo, Japan.
FAU - Nemeth, Gyorgy
AU  - Nemeth G
AD  - Department of Clinical Research, Gedeon Richter Plc., Budapest, Hungary.
AD  - Department of Medical Affairs, Gedeon Richter Plc, Budapest, Hungary.
LA  - eng
PT  - Journal Article
DEP - 20200303
PL  - Switzerland
TA  - Front Psychiatry
JT  - Frontiers in psychiatry
JID - 101545006
PMC - PMC7062963
OTO - NOTNLM
OT  - adolescents
OT  - cariprazine
OT  - elderly
OT  - safety
OT  - schizophrenia
EDAT- 2020/03/21 06:00
MHDA- 2020/03/21 06:01
PMCR- 2020/03/03
CRDT- 2020/03/21 06:00
PHST- 2019/10/15 00:00 [received]
PHST- 2020/01/23 00:00 [accepted]
PHST- 2020/03/21 06:00 [entrez]
PHST- 2020/03/21 06:00 [pubmed]
PHST- 2020/03/21 06:01 [medline]
PHST- 2020/03/03 00:00 [pmc-release]
AID - 10.3389/fpsyt.2020.00061 [doi]
PST - epublish
SO  - Front Psychiatry. 2020 Mar 3;11:61. doi: 10.3389/fpsyt.2020.00061. eCollection 
      2020.