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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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 9, 2011
Last updated: July 5, 2016
Last verified: July 2016
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).

Condition Intervention Phase
Major Depressive Disorder
Drug: DVS SR
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Children's Depression Rating Scale, Revised (CDRS-R) total score change from baseline [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Improvement (CGI I) score [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity (CGI S) score change from baseline [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • CGI I response (score of 1 or 2) [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Remission on the CDRS-R (score ≤28) [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: February 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01371708

  Show 36 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01371708     History of Changes
Other Study ID Numbers: B2061030  3151A6-3344  2008-001876-67 
Study First Received: June 9, 2011
Last Updated: July 5, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs processed this record on October 21, 2016