A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01371734
First received: June 9, 2011
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).


Condition Intervention Phase
Major Depressive Disorder
Drug: Desvenlafaxine Succinate Sustained-Release
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate the Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-Release (DVS SR) 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:
  • Change from baseline to Week 8 in the Child Depression Rating Scale - Revised (CDRS-R): Total Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Improvement (CGI-I) Score at the Week 8 visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity Score at the Week 8 visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement Response (score 1 or 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: August 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Desvenlafaxine Succinate Sustained-Release
Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
Experimental: 2 Drug: Desvenlafaxine Succinate Sustained-Release
Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
Experimental: 3 Drug: Placebo
Subjects randomized to the Placebo treatment arm will receive placebo tablets

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >=7 and <18 years of age
  • Primary diagnosis of major depressive disorder (MDD)
  • CDRS-R score >40

Exclusion Criteria:

  • History of suicidal behavior or requires precaution against suicide
  • Not in generally healthy medical condition
  • History of psychosis or bipolar disorder
  • Seizure disorder
  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: NCT01371734

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371734     History of Changes
Other Study ID Numbers: B2061032, 3151A6-3343
Study First Received: June 9, 2011
Last Updated: August 18, 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
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014