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Major Depressive Disorder | A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

Major Depressive Disorder research study

What is the primary objective of this study?

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).

Who is eligible to participate?

Inclusion Criteria: - Age >=7 and <18 years of age - Primary diagnosis of major depressive disorder (MDD) - CDRS-R score >40 Exclusion Criteria: - History of suicidal behaviour, or requires precaution against suicide - Not in generally healthy medical condition - History of psychosis or bipolar disorder - Seizure disorder

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:desvenlafaxine succinate sustained releaseSubjects 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:fluoxetineSubjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules

Drug:placeboSubjects randomized to the placebo group receive corresponding placebo tablets and/capsules

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DVS SR

FluoxetineActive control for assay sensitivity

Placebo

Study Status

Completed

Start Date: November 2011

Completed Date: March 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score

Secondary Outcome: Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01372150

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