PMID- 29035574
OWN - NLM
STAT- MEDLINE
DCOM- 20190416
LR  - 20190416
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 28
IP  - 1
DP  - 2018 Feb
TI  - A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with 
      Depressive or Anxiety Disorders.
PG  - 47-54
LID - 10.1089/cap.2017.0047 [doi]
AB  - OBJECTIVES: In this 6-month open-label extension (OLE) of NCT01491035 (a 14-day, 
      open-label, pharmacokinetic/safety lead-in study), the long-term safety and 
      tolerability of vortioxetine (5-20 mg/day) were investigated in children and 
      adolescents with a DSM-IV-TR diagnosis of depressive or anxiety disorder in the 
      United States or Germany. The study also was designed to provide data to inform 
      dose selection and titration in future pediatric studies with vortioxetine. 
      METHODS: Safety evaluations included spontaneously reported adverse events (AEs), 
      the Columbia Suicide Severity Rating Scale (C-SSRS), and the Pediatric Adverse 
      Events Rating Scale (PAERS; clinician administered). Clinical effectiveness was 
      determined by Clinical Global Impressions. Comorbid 
      attention-deficit/hyperactivity disorder was permitted, including concomitant use 
      of stimulant medication (US sites only). RESULTS: Of the 47 patients who 
      completed the lead-in period, 41 continued into the OLE. Most patients (n = 39 
      [95%]) continued their previous dose regimen. Twenty-one patients (51%) withdrew 
      during the OLE; the most common primary reasons were administrative [n = 8], AEs 
      [n = 4], and lack of efficacy [n = 3]. Thirty-five patients (85%) had >/=1 AE, 86% 
      of which were mild or moderate in severity. Five patients (12%) reported a severe 
      AE, none of which was considered related to study medication. The most common AEs 
      (>/=10%) were headache (27%), nausea (20%), dysmenorrhea (females; 19%), and 
      vomiting (15%), with no relationship between AE intensity and age or dose. Five 
      patients reported instances of suicidal ideation during the OLE, one of whom also 
      reported this during the lead-in period. Two patients had nonsuicidal 
      self-injurious behavior; one had a nonfatal suicide attempt. Throughout the 
      study, there was a decrease over time in the incidence and intensity of AEs 
      collected using the PAERS. Effectiveness assessment indicated a trend toward 
      improvement based on numeric results. CONCLUSION: This OLE confirms the findings 
      from the lead-in study, which concluded that a dosing strategy of 5-20 mg/day is 
      safe, well tolerated, and suitable for future clinical studies of vortioxetine in 
      pediatric patients.
FAU - Findling, Robert L
AU  - Findling RL
AD  - 1 The Johns Hopkins University and the Kennedy Krieger Institute, Baltimore, 
      Maryland.
FAU - Robb, Adelaide S
AU  - Robb AS
AD  - 2 Children's National Health System , Washington, District of Columbia.
FAU - DelBello, Melissa P
AU  - DelBello MP
AD  - 3 Cincinnati Children's Hospital Medical Center , Cincinnati, Ohio.
FAU - Huss, Michael
AU  - Huss M
AD  - 4 Universitatsmedizin, Klinik fur Kinder- und Jugendpsychiatrie und 
      -psychotherapie , Mainz, Germany .
FAU - McNamara, Nora K
AU  - McNamara NK
AD  - 5 Department of Psychiatry-Child/Adolescent, UH Case Medical Center , Cleveland, 
      Ohio.
FAU - Sarkis, Elias H
AU  - Sarkis EH
AD  - 6 Sarkis Family Psychiatry , Gainesville, Florida.
FAU - Scheffer, Russell E
AU  - Scheffer RE
AD  - 7 KU School of Medicine , Wichita, Kansas.
FAU - Poulsen, Lis H
AU  - Poulsen LH
AD  - 8 Paediatric Neuro-Psychiatry and Quantitative Pharmacology, H. Lundbeck A/S , 
      Valby, Denmark .
FAU - Chen, Grace
AU  - Chen G
AD  - 9 Quantitative Clinical Pharmacology, Takeda Pharmaceuticals U.S.A., Inc. , 
      Deerfield, Illinois.
FAU - Lemming, Ole M
AU  - Lemming OM
AD  - 10 Biostatistics, H. Lundbeck A/S , Valby, Denmark .
FAU - Auby, Philippe
AU  - Auby P
AD  - 8 Paediatric Neuro-Psychiatry and Quantitative Pharmacology, H. Lundbeck A/S , 
      Valby, Denmark .
LA  - eng
SI  - ClinicalTrials.gov/NCT01491035
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20171016
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Anti-Anxiety Agents)
RN  - 0 (Antidepressive Agents)
RN  - 3O2K1S3WQV (Vortioxetine)
SB  - IM
MH  - Adolescent
MH  - Anti-Anxiety Agents/administration & dosage/adverse effects/pharmacokinetics
MH  - Antidepressive Agents/administration & dosage/adverse effects/pharmacokinetics
MH  - Anxiety Disorders/*drug therapy/physiopathology
MH  - Child
MH  - Depressive Disorder, Major/*drug therapy/physiopathology
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Germany
MH  - Humans
MH  - Male
MH  - Prospective Studies
MH  - Psychiatric Status Rating Scales
MH  - Treatment Outcome
MH  - United States
MH  - Vortioxetine/*administration & dosage/adverse effects/pharmacokinetics
PMC - PMC5771527
OTO - NOTNLM
OT  - adolescents
OT  - antidepressant
OT  - anxiety
OT  - children
OT  - depression
OT  - dosing
OT  - long-term safety
OT  - pediatric patients
OT  - vortioxetine
EDAT- 2017/10/17 06:00
MHDA- 2019/04/17 06:00
PMCR- 2018/02/01
CRDT- 2017/10/17 06:00
PHST- 2017/10/17 06:00 [pubmed]
PHST- 2019/04/17 06:00 [medline]
PHST- 2017/10/17 06:00 [entrez]
PHST- 2018/02/01 00:00 [pmc-release]
AID - 10.1089/cap.2017.0047 [pii]
AID - 10.1089/cap.2017.0047 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2018 Feb;28(1):47-54. doi: 
      10.1089/cap.2017.0047. Epub 2017 Oct 16.