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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01371721
First received: June 9, 2011
Last updated: June 20, 2014
Last verified: June 2014
  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 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

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 ]
  • Clinical Global Impression - Improvement (CGI-I) response (score of 1 or 2) [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Remission on the Children's Depression Rating Scale, Revised (CDRS-R) (score <=28) [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 333
Study Start Date: February 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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 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
  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 ClinicalTrials.gov identifier: NCT01371721

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

  Show 42 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371721     History of Changes
Other Study ID Numbers: B2061031, 3151A6-3357
Study First Received: June 9, 2011
Last Updated: June 20, 2014
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 July 22, 2014