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

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372150
First received: June 9, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs 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: fluoxetine
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, Fluoxetine-Referenced, Parallel-Group Study To Evaluate The Safety, Efficacy, And Tolerability Of DVS SR In 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 visit in the Children's 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 ]
  • CGI-S score change from baseline at the Week 8 visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-I response (1 or 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: November 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DVS SR Drug: desvenlafaxine succinate sustained release
Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
Fluoxetine
Active control for assay sensitivity
Drug: fluoxetine
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
Experimental: Placebo Drug: placebo
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules

  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 behaviour, or requires precaution against suicide
  • Not in generally healthy medical condition
  • History of psychosis or bipolar disorder
  • Seizure disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372150

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

  Show 49 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: NCT01372150     History of Changes
Other Study ID Numbers: B2061014, 3151A6-3356
Study First Received: June 9, 2011
Last Updated: March 25, 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
Fluoxetine
O-desmethylvenlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014