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Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder
Objective: To evaluate the short-term efficacy and safety of desvenlafaxine versus placebo in the treatment of children and adolescents with major depressive disorder (MDD). Methods: Outpatient children (7–11 years) and adolescents (12–17 years) who met DSM-IV-TR criteria for MDD and had screening a...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mary Ann Liebert, Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5771531/ https://www.ncbi.nlm.nih.gov/pubmed/29185786 http://dx.doi.org/10.1089/cap.2017.0099 |
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author | Atkinson, Sarah Lubaczewski, Shannon Ramaker, Sara England, Richard D. Wajsbrot, Dalia B. Abbas, Richat Findling, Robert L. |
author_facet | Atkinson, Sarah Lubaczewski, Shannon Ramaker, Sara England, Richard D. Wajsbrot, Dalia B. Abbas, Richat Findling, Robert L. |
author_sort | Atkinson, Sarah |
collection | PubMed |
description | Objective: To evaluate the short-term efficacy and safety of desvenlafaxine versus placebo in the treatment of children and adolescents with major depressive disorder (MDD). Methods: Outpatient children (7–11 years) and adolescents (12–17 years) who met DSM-IV-TR criteria for MDD and had screening and baseline Children's Depression Rating Scale-Revised (CDRS-R) total scores >40 were randomly assigned to 8 weeks of treatment with placebo, low exposure desvenlafaxine (20, 30, or 35 mg/day based on baseline weight), or higher exposure desvenlafaxine (25, 35, or 50 mg/day based on baseline weight). The primary efficacy endpoint was change from baseline in CDRS-R total score at week 8, analyzed using a mixed-effects model for repeated measures. Secondary efficacy assessments included Clinical Global Impressions-Severity and Clinical Global Impressions-Improvement scales. Safety assessments included adverse events and the Columbia-Suicide Severity Rating Scale. Results: The safety population included 363 patients (children, n = 109; adolescents, n = 254). No statistical separation from placebo was observed for either desvenlafaxine group for CDRS-R total score or for any secondary efficacy endpoint. At week 8, adjusted mean (standard error) changes from baseline in CDRS-R total score for the desvenlafaxine low exposure, desvenlafaxine high exposure, and placebo groups were −23.7 (1.1), −24.4 (1.1), and −22.9 (1.1), respectively. The incidence of adverse events was similar among groups. Conclusion: Low and high exposure desvenlafaxine groups did not demonstrate efficacy for the treatment of MDD in children and adolescents in this double-blind, placebo-controlled trial. Desvenlafaxine (20–50 mg/day) was generally safe and well tolerated with no new safety signals identified in pediatric patients with MDD in this study. |
format | Online Article Text |
id | pubmed-5771531 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Mary Ann Liebert, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-57715312018-02-01 Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder Atkinson, Sarah Lubaczewski, Shannon Ramaker, Sara England, Richard D. Wajsbrot, Dalia B. Abbas, Richat Findling, Robert L. J Child Adolesc Psychopharmacol Original Articles Objective: To evaluate the short-term efficacy and safety of desvenlafaxine versus placebo in the treatment of children and adolescents with major depressive disorder (MDD). Methods: Outpatient children (7–11 years) and adolescents (12–17 years) who met DSM-IV-TR criteria for MDD and had screening and baseline Children's Depression Rating Scale-Revised (CDRS-R) total scores >40 were randomly assigned to 8 weeks of treatment with placebo, low exposure desvenlafaxine (20, 30, or 35 mg/day based on baseline weight), or higher exposure desvenlafaxine (25, 35, or 50 mg/day based on baseline weight). The primary efficacy endpoint was change from baseline in CDRS-R total score at week 8, analyzed using a mixed-effects model for repeated measures. Secondary efficacy assessments included Clinical Global Impressions-Severity and Clinical Global Impressions-Improvement scales. Safety assessments included adverse events and the Columbia-Suicide Severity Rating Scale. Results: The safety population included 363 patients (children, n = 109; adolescents, n = 254). No statistical separation from placebo was observed for either desvenlafaxine group for CDRS-R total score or for any secondary efficacy endpoint. At week 8, adjusted mean (standard error) changes from baseline in CDRS-R total score for the desvenlafaxine low exposure, desvenlafaxine high exposure, and placebo groups were −23.7 (1.1), −24.4 (1.1), and −22.9 (1.1), respectively. The incidence of adverse events was similar among groups. Conclusion: Low and high exposure desvenlafaxine groups did not demonstrate efficacy for the treatment of MDD in children and adolescents in this double-blind, placebo-controlled trial. Desvenlafaxine (20–50 mg/day) was generally safe and well tolerated with no new safety signals identified in pediatric patients with MDD in this study. Mary Ann Liebert, Inc. 2018-02-01 2018-02-01 /pmc/articles/PMC5771531/ /pubmed/29185786 http://dx.doi.org/10.1089/cap.2017.0099 Text en © Sarah Atkinson et al. 2017; Published by Mary Ann Liebert, Inc. This article is available under the Creative Commons License CC-BY-NC (http://creativecommons.org/licenses/by-nc/4.0). This license permits non-commercial use, distribution and reproduction in any medium, provided the original work is properly cited. Permission only needs to be obtained for commercial use and can be done via RightsLink. |
spellingShingle | Original Articles Atkinson, Sarah Lubaczewski, Shannon Ramaker, Sara England, Richard D. Wajsbrot, Dalia B. Abbas, Richat Findling, Robert L. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder |
title | Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder |
title_full | Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder |
title_fullStr | Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder |
title_full_unstemmed | Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder |
title_short | Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder |
title_sort | desvenlafaxine versus placebo in the treatment of children and adolescents with major depressive disorder |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5771531/ https://www.ncbi.nlm.nih.gov/pubmed/29185786 http://dx.doi.org/10.1089/cap.2017.0099 |
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