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

NCT01371708 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: B20610303151A6-33442008-001876-67
• Study Type: interventional
• Target: 283
• Locations: 2 countries
• Sites: 36

Brief 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).

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; Depression

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)

  A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.

  From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

• Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)

  A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.

  From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

Secondary Outcomes (10)

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

  From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

• Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)

  From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

• Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases

  From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

• Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)

  From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

• Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases

  From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

Study Arms (1)

Desvenlafaxine Succinate Sustained-Release

EXPERIMENTAL

Drug: DVS SR

Interventions

DVS SR DRUG

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

Desvenlafaxine Succinate Sustained-Release

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (36)

The University Of Alabama At Birmingham, Office Of Psychiatric Research

Birmingham, Alabama, 35294-0009, United States

Location

Center for Advanced Improvement

Tucson, Arizona, 85719, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

SJS Clinical Research, Inc.

Destin, Florida, 32541, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Clinical Neuroscience Solutions

Jacksonville, Florida, 32256, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Millenia Psychiatry & Research, Inc.

Orlando, Florida, 32839, United States

Location

Janus Center for Psychiatric Research

West Palm Beach, Florida, 33407, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

Clinco

Terre Haute, Indiana, 47802, United States

Location

Pharmasite Research, Inc

Baltimore, Maryland, 21208, United States

Location

Millennium Psychiatric Associates, LLC

Creve Coeur, Missouri, 63141, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

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

Buffalo, New York, 14215, United States

Location

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

Glen Oaks, New York, 11004, United States

Location

Bioscience Research, LLC.

Mount Kisco, New York, 10549, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Stony Brook University Medical Center, child and Adolescent Psychiatry

Stony Brook, New York, 11794-8790, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Research Strategies of Memphis, LLC.

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials

Austin, Texas, 78731, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Clinical Trials of Texas, INC

San Antonio, Texas, 78229, United States

Location

Allance Research Group

Richmond, Virginia, 23230, United States

Location

Alliance Research Group

Richmond, Virginia, 23230, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Virginia Treatment Center for Children

Richmond, Virginia, 23298, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Biomedica Research Group

Santiago, Santiago Metropolitan, 7500710, Chile

Location

Related Publications (1)

• 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.

  PMID: 30419989 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: February 2, 2012
• Primary Completion: April 22, 2016
• Study Completion: April 22, 2016
• Last Updated: July 27, 2017
• Results First Posted: December 8, 2016

Record last verified: 2017-06

Locations

US (35); CL (1)