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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 is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01371708
First received: June 9, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Intervention Model: Single Group Assignment
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:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline to final on therapy visit in the Children's Depression Rating Scale, Revised (CDRS-R) total score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Improvement (CGI I) score at the final on therapy visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale (CGI S) score change from baseline at the final on therapy visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • CGI I response (score of 1 or 2) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Remission on the CDRS-R (score ≤28) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 333
Study Start Date: January 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 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

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371708

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 36 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371708     History of Changes
Other Study ID Numbers: B2061030
Study First Received: June 9, 2011
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Major Depressive Disorder
MDD
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013