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

NCT ID: NCT01371708

Last Updated: 2017-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-02

Study Completion Date

2016-04-22

Brief Summary

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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).

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Desvenlafaxine Succinate Sustained-Release

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

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

Interventions

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DVS SR

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The University Of Alabama At Birmingham, Office Of Psychiatric Research

Birmingham, Alabama, United States

Site Status

Center for Advanced Improvement

Tucson, Arizona, United States

Site Status

Sun Valley Research Center

Imperial, California, United States

Site Status

MCB Clinical Research Centers

Colorado Springs, Colorado, United States

Site Status

Institute of Living/Hartford Hospital

Hartford, Connecticut, United States

Site Status

SJS Clinical Research, Inc.

Destin, Florida, United States

Site Status

Sarkis Clinical Trials

Gainesville, Florida, United States

Site Status

Clinical Neuroscience Solutions

Jacksonville, Florida, United States

Site Status

Medical Research Group of Central Florida

Orange City, Florida, United States

Site Status

Millenia Psychiatry & Research, Inc.

Orlando, Florida, United States

Site Status

Janus Center for Psychiatric Research

West Palm Beach, Florida, United States

Site Status

Northwest Behavioral Research Center

Marietta, Georgia, United States

Site Status

Capstone Clinical Research

Libertyville, Illinois, United States

Site Status

Baber Research Group

Naperville, Illinois, United States

Site Status

Clinco

Terre Haute, Indiana, United States

Site Status

Pharmasite Research, Inc

Baltimore, Maryland, United States

Site Status

Millennium Psychiatric Associates, LLC

Creve Coeur, Missouri, United States

Site Status

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, United States

Site Status

Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate

Buffalo, New York, United States

Site Status

The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System

Glen Oaks, New York, United States

Site Status

Bioscience Research, LLC.

Mount Kisco, New York, United States

Site Status

Finger Lakes Clinical Research

Rochester, New York, United States

Site Status

Stony Brook University Medical Center, child and Adolescent Psychiatry

Stony Brook, New York, United States

Site Status

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, United States

Site Status

Discovery and Wellness Center for Children/University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Research Strategies of Memphis, LLC.

Memphis, Tennessee, United States

Site Status

FutureSearch Trials

Austin, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas, INC

San Antonio, Texas, United States

Site Status

Allance Research Group

Richmond, Virginia, United States

Site Status

Alliance Research Group

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Virginia Treatment Center for Children

Richmond, Virginia, United States

Site Status

Eastside Therapeutic Resource

Kirkland, Washington, United States

Site Status

Biomedica Research Group

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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United States Chile

References

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Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128.

Reference Type DERIVED
PMID: 30419989 (View on PubMed)

Related Links

Other Identifiers

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3151A6-3344

Identifier Type: OTHER

Identifier Source: secondary_id

2008-001876-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B2061030

Identifier Type: -

Identifier Source: org_study_id

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