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Major Depressive Disorder | A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

Major Depressive Disorder research study

What is the primary objective of this study?

This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).

Who is eligible to participate?

Inclusion Criteria: - Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR - Willingness and ability to comply with scheduled visits, treatment plan and procedures Exclusion Criteria: - Subject requires precaution against suicide - Subject not in a generally healthy condition

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:DVS SRSubjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.

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.

Desvenlafaxine Succinate Sustained-Release

Study Status

Completed

Start Date: February 2012

Completed Date: October 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Percentage of Participants Experiencing a Treatment Emergent Adverse Event

Secondary Outcome: Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01371721

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