drugset / Trial / NCT01372150

A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

NCT01372150 ↗

Phase 3 Completed 340 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).

Timeline

Start
2011-11-17
Primary completion
2015-03-20
Completion
2015-03-20

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs DVS SR; p = 0.739; Mean Difference (Final Values) -0.47 (95% CI -3.23 to 2.30); MMRM NCT01372150 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Desvenlafaxine Other / unclassified 25 mg Oral
Subject Desvenlafaxine Other / unclassified 35 mg Oral
Subject Desvenlafaxine Other / unclassified 50 mg Oral
Subject Fluoxetine Small molecule 20 mg Oral