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Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials

Published online by Cambridge University Press:  13 November 2018

Sarah Atkinson Open the ORCID record for Sarah Atkinson [Opens in a new window] ,
Louise Thurman ,
Sara Ramaker ,
Gina Buckley ,
Sarah Ruta Jones ,
Richard England  and
Dalia Wajsbrot
Sarah Atkinson*
Affiliation:
Finger Lakes Clinical Research, Rochester, New York
Louise Thurman
Affiliation:
IPS Research, Oklahoma City, Oklahoma
Sara Ramaker
Affiliation:
Pfizer Inc., Collegeville, Pennsylvania
Gina Buckley
Affiliation:
Pfizer Inc., Collegeville, Pennsylvania
Sarah Ruta Jones
Affiliation:
Pfizer Inc., Collegeville, Pennsylvania
Richard England
Affiliation:
Pfizer Inc., Groton, Connecticut
Dalia Wajsbrot
Affiliation:
Pfizer Inc., New York, New York
*
*Address for correspondence: Sarah Atkinson, Finger Lakes Clinical Research, 885 S. Winton Road, Rochester, NY 14618, USA. (Email: [email protected])
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Abstract

Objective

Two similarly designed extension studies evaluated the long-term safety and tolerability of desvenlafaxine for the treatment of children and adolescents with major depressive disorder (MDD). Efficacy was evaluated as a secondary objective.

Methods

Both 6-month, open-label, flexible-dose extension studies enrolled children and adolescents who had completed one of two double-blind, placebo-controlled, lead-in studies. One lead-in study included a 1-week transition period prior to the extension study. Patients received 26-week treatment with flexible-dose desvenlafaxine (20–50 mg/d). Safety assessments included comprehensive psychiatric evaluations, vital sign assessments, laboratory evaluations, 12-lead electrocardiogram, physical examination with Tanner assessment, and Columbia-Suicide Severity Rating Scale. Adverse events (AEs) were collected throughout the studies. Efficacy was assessed using the Children’s Depression Rating Scale–Revised (CDRS-R).

Results

A total of 552 patients enrolled (completion rates: 66.4 and 69.1%). AEs were reported by 79.4 and 79.1% of patients in the two studies; 8.9 and 5.2% discontinued due to AEs. Treatment-emergent suicidal ideation or behavior was reported for 16.6 and 14.1% of patients in the two studies. Mean (SD) CDRS-R total score decreased from 33.83 (11.93) and 30.92 (10.20) at the extension study baseline to 24.31 (7.48) and 24.92 (8.45), respectively, at week 26.

Conclusion

Desvenlafaxine 20 to 50 mg/d was generally safe and well tolerated with no new safety signals identified in children and adolescents with MDD who received up to 6 months of treatment in these studies. Patients maintained the reduction in severity of depressive symptoms observed in all treatment groups at the end of the lead-in study.

Keywords

Adolescentsantidepressantchildrenclinical trialsafety
Type
Original Research
Information
CNS Spectrums , Volume 24 , Issue 5 , October 2019 , pp. 496 - 506
Copyright
© Cambridge University Press 2018 

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Footnotes

This study was sponsored by Pfizer. Medical writing support was provided by Kathleen M. Dorries, PhD, of Peloton Advantage and was funded by Pfizer Inc.ClinicalTrials.gov Identifiers: NCT01371708, NCT01371721

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