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

NCT01372150 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2019-01-15

Study results available
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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).

Conditions

Interventions

DRUG

desvenlafaxine succinate sustained release

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.

DRUG

fluoxetine

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

DRUG

placebo

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372150 on ClinicalTrials.gov