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

A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 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

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: DVS SR

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Hospital Aranda de la Parra, S.A. de C.V.
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64010
      • CIT-Neuropsique, S.C.
• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex Neuroscience Research, Inc.
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Dedicated Clinical Research
    • Tucson, Arizona, United States, 85724
      • University of Arizona Clinical and Translational Science Center (CATS)
    • Tucson, Arizona, United States, 85724
      • University of Arizona College of Medicine Dept of Psychiatry
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Incorporated
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Orange, California, United States, 92868
      • Pacific Clinical Research Medical Group
    • Orange, California, United States, 92868
      • Neuropsychiatric Research Center of Orange County
    • Wildomar, California, United States, 92595
      • Elite Clinical Trials, Incorporated
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Florida
    • Hialeah, Florida, United States, 33013
      • Amedica Research Institute, Incorporated
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Winter Park, Florida, United States, 32789-3747
      • Kolin Research Group
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Smyrna, Georgia, United States, 30080
      • Institute For Behavioral Medicine, Llc
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Psychiatric Associates
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials,
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • St. Charles, Missouri, United States, 63303
      • St. Charles Psychiatric Associates - Midwest Research Group
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry and Behavioral Medicine, Incorporated
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
    • Oklahoma City, Oklahoma, United States, 73118
      • Paradigm Research Professionals, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon), Incorporated
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • San Antonio, Texas, United States, 78229
      • Focus & Balance, LLC
    • Witchita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle) Llc
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53227
      • Rogers Center for Research and Training, Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desvenlafaxine Succinate Sustained-Release	Drug: DVS SR; Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Experiencing a Treatment Emergent Adverse Event	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases	A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases	Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 13, 2011

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Depression; MDD; Major Depressive Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: B2061031; 3151A6-3357 (Other Identifier: Alias Study Number); 2008-002064-34 (EudraCT Number)