CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 340 enrolled
Drug / intervention
desvenlafaxine succinate sustained release +2 moredrug
Likely dose
desvenlafaxine succinate sustained release 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01372150
NCT01372150Phase 3Completed
CompareCT.gov

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF DESVENLAFAXINE SUCCINATE SUSTAINED RELEASE (DVS SR) IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER

Pfizer·interventional·Posted Jun 13, 2011·Updated Jan 15, 2019

In Brief

A Phase 3 clinical trial evaluating desvenlafaxine succinate sustained release, fluoxetine, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 340 participants across 43 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesMexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2011
Enrollment StartNov 17, 2011
Primary CompletionMar 20, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.1 years ago

Interventions

desvenlafaxine succinate sustained releasedrug

Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.

fluoxetinedrug

Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules

placebodrug

Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules