TY - JOUR
T1 - A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders
AU - Findling, Robert L.
AU - Robb, Adelaide S.
AU - DelBello, Melissa P.
AU - Huss, Michael
AU - McNamara, Nora K.
AU - Sarkis, Elias H.
AU - Scheffer, Russell E.
AU - Poulsen, Lis H.
AU - Chen, Grace
AU - Lemming, Ole M.
AU - Auby, Philippe
N1 - Funding Information:
Funding: This study was supported by H. Lundbeck A/S as part of a joint clinical development program with Takeda Pharmaceutical Company, Ltd. Assistance with writing and manuscript preparation was provided by Nicole Coolbaugh and Philip Sjostedt, BPharm, with The Medicine Group and was funded by the Takeda Pharmaceutical Company, Ltd., and H. Lundbeck A/S.
Funding Information:
R.L.F. receives or has received research support from, acted as a consultant for, and/or served on a speaker’s bureau for Actavis, Akili, Alcobra, American Academy of Child and Adolescent Psychiatry, American Psychiatric Press, Bracket, CogCubed, Cognition Group, Coronado Biosciences, Elsevier, Epharma Solutions, Forest, Gen-entech, GlaxoSmithKline, Guilford Press, Ironshore, Johns Hopkins University Press, KemPharm, Lundbeck, Medgenics, Merck, NIH, Neurim, Novartis, Otsuka, PCORI, Pfizer, Physicians Postgraduate Press, Purdue, Rhodes Pharmaceuticals, Roche, Sage, Shire, Suno-vion, Supernus Pharmaceuticals, Syneurx, Takeda, Teva, Touch-Point, Tris, Validus, and WebMD. A.S.R. receives or has received research support from, acted as a consultant for, received travel support from, and/or served on a data safety monitoring board for Aevi Genomics, Allergan/Actavis/Forest, American Academy of Child and Adolescent Psychiatry, American Academy of Pediatrics, Bracket, Case Western Reserve University, College of Psychiatric and Neurologic Pharmacists, Eli Lilly, GlaxoSmithKline, Guilford Press, Ironshore, Johnson & Johnson/Janssen, Lundbeck, Neuro-netics, Neuroscience Education Institute, Nevada Psychiatric Association, National Institutes of Health, North American Center for Continuing Medical Education, Otsuka, Pfizer, Rhodes Pharmaceuticals, Sunovion, Supernus, SyneuRx, Takeda, and University of Cambridge. M.P.D.-B. receives or has received research support from, acted as a consultant for, received travel support from, and/or served on a speaker’s bureau for Actavis, American Academy of Child and Adolescent Psychiatry, Bracket, Eli Lilly, GlaxoSmithK-line, Guilford Press, Johnson & Johnson, Lundbeck, Pfizer, Purdue, Shire, Sunovion, Supernus, and Takeda. M.H. receives or has received research support from, acted as a consultant for, received travel support from, and/or served on a speaker’s bureau for Actelion, Eli Lilly, Engelhardt, Janssen-Cilaq, Lundbeck, Medice, Novartis, Shire, and Steiner-Arzneimittel and has an international patent on Doppler radar to assess ADHD (Government Research Grants: BMBF, BMFT, and BfArM). N.K.M. receives or has received research support from Forest Pharmaceuticals, Lundbeck, Otsuka, National Institute of Mental Health, Roche, Sunovion, Shire, and Tonix and received an honorarium for participation and travel support for a meeting sponsored by Sunovion. E.H.S. receives or has received research support from Alcobra, Alkermes, Allergan, Assurex, Aus-pexm, Daiichi-Sankyo, Eli Lilly, Forest Pharmaceuticals, Lundbeck, Indivior, Ironshore, Medgenics, Otsuka, Palatin, Pfizer, Polus, Sage, Shire, Sunovion, Supernus, Takeda, Tal Medical, TEVA, and Tonix. R.E.S. has no outside conflicts of interest and has not received a stipend or any other payment. At the time of this study, L.H.P. was an employee of Lundbeck. G.C. is an employee of Takeda Pharmaceuticals Company, Ltd. O.M.L. is an employee of Lundbeck. At the time of this study, P.A. was an employee of Lundbeck.
Publisher Copyright:
© Robert L. Findling et al. 2017; Published by Mary Ann Liebert, Inc.
PY - 2018/2
Y1 - 2018/2
N2 - 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.
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.
KW - adolescents
KW - antidepressant
KW - anxiety
KW - children
KW - depression
KW - dosing
KW - long-term safety
KW - pediatric patients
KW - vortioxetine
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U2 - 10.1089/cap.2017.0047
DO - 10.1089/cap.2017.0047
M3 - Article
C2 - 29035574
AN - SCOPUS:85041033338
VL - 28
SP - 47
EP - 54
JO - Journal of Child and Adolescent Psychopharmacology
JF - Journal of Child and Adolescent Psychopharmacology
SN - 1044-5463
IS - 1
ER -