TY  - JOUR
PY  - 2018//
TI  - Safety, tolerability, and efficacy of desvenlafaxine in children and adolescents with major depressive disorder: results from two open-label extension trials
JO  - CNS spectrums
A1  - Atkinson, Sarah
A1  - Thurman, Louise
A1  - Ramaker, Sara
A1  - Buckley, Gina
A1  - Jones, Sarah Ruta
A1  - England, Richard
A1  - Wajsbrot, Dalia
SP  - 1
EP  - 11
VL  - ePub
IS  - ePub
N2  - 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. <br><br>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). <br><br>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. <br><br>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.<p />  <p>Language: en</p>
LA  - en
SN  - 1092-8529
UR  - http://dx.doi.org/10.1017/S1092852918001128
ID  - ref1
ER  -