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A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder

NCT01371708•Pfizer

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

7 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Completed study B2061032 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

•Requires precaution against suicide
•Not in generally healthy medical condition
•Poor compliance with study drug or study procedures during participation in study B2061032

Locations (36)

The University Of Alabama At Birmingham, Office Of Psychiatric Research

Birmingham, Alabama, United States

Center for Advanced Improvement

Tucson, Arizona, United States

Sun Valley Research Center

Imperial, California, United States

MCB Clinical Research Centers

Colorado Springs, Colorado, United States

Institute of Living/Hartford Hospital

Hartford, Connecticut, United States

SJS Clinical Research, Inc.

Destin, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Clinical Neuroscience Solutions

Jacksonville, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Millenia Psychiatry & Research, Inc.

Orlando, Florida, United States

Key Dates

Start Date

February 2, 2012

Primary Completion Date

April 22, 2016

Completion Date

April 22, 2016

Last Updated

July 27, 2017

Enrollment

283

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

DVS SR

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

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Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)