Desvenlafaxine Versus Placebo in a Fluoxetine-Referenced Study of Children and Adolescents with Major Depressive Disorder
AuthorWeihs, Karen L.
England, Richard D.
Wajsbrot, Dalia B.
AffiliationUniv Arizona, Dept Psychiat
MetadataShow full item record
PublisherMARY ANN LIEBERT, INC
CitationWeihs Karen L., Murphy William, Abbas Richat, Chiles Deborah, England Richard D., Ramaker Sara, and Wajsbrot Dalia B..Journal of Child and Adolescent Psychopharmacology.Feb 2018.ahead of printhttp://doi.org/10.1089/cap.2017.0100
Rights© Karen L. Weihs et al. 2017; Published by Mary Ann Liebert, Inc.
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AbstractObjectives: To evaluate the short-term efficacy and safety of desvenlafaxine (25-50mg/d) compared with placebo in 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-week treatment with placebo, desvenlafaxine (25, 35, or 50mg/d based on baseline weight), or fluoxetine (20mg/d). 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 endpoints included week 8 Clinical Global Impressions-Severity, Clinical Global Impressions-Improvement (CGI-I), and response (CGI-I 2). Safety assessments included adverse events, physical and vital sign measurements, laboratory evaluations, electrocardiogram, and the Columbia-Suicide Severity Rating Scale. Results: The safety population included 339 patients (children, n=130; adolescents, n=209). The primary endpoint, change from baseline in CDRS-R total score at week 8, did not statistically separate from placebo, for either desvenlafaxine (adjusted mean [standard error] change, -22.6 [1.17]) or fluoxetine (-24.8 [1.17]; placebo, -23.1 [1.18]). Week 8 CGI-I response rates were significantly greater for fluoxetine (78.2%; p=0.017) than for placebo (62.6%); desvenlafaxine (68.7%) did not differ from placebo. Other secondary outcomes were consistent with those obtained with CDRS-R. Rates of treatment-emergent adverse events were comparable among treatment groups (desvenlafaxine, 60.0%; placebo, 70.5%; and fluoxetine, 64.3%). Conclusion: Desvenlafaxine did not demonstrate efficacy for treating MDD in children and adolescents in this trial. Because neither desvenlafaxine nor the reference medication, fluoxetine, demonstrated a statistically significant difference from placebo on the primary endpoint, this was considered a failed trial and no efficacy conclusions can be drawn. Desvenlafaxine 25-50mg/d was generally safe and well tolerated in children and adolescents in this study.
Note12 month embargo; Published online: 30 November 2017
VersionFinal accepted manuscript