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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

  • Sarah Atkinson (a1), Louise Thurman (a2), Sara Ramaker (a3), Gina Buckley (a3), Sarah Ruta Jones (a3), Richard England (a4) and Dalia Wajsbrot (a5)...

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.

Copyright

Corresponding author

*Address for correspondence: Sarah Atkinson, Finger Lakes Clinical Research, 885 S. Winton Road, Rochester, NY 14618, USA. (Email: sda@flclinical.com)

Footnotes

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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

Footnotes

References

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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

  • Sarah Atkinson (a1), Louise Thurman (a2), Sara Ramaker (a3), Gina Buckley (a3), Sarah Ruta Jones (a3), Richard England (a4) and Dalia Wajsbrot (a5)...

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