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Trial record 44 of 89 for:    DESVENLAFAXINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01372150
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : November 20, 2015
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 9, 2011
First Posted Date  ICMJE June 13, 2011
Results First Submitted Date  ICMJE October 19, 2015
Results First Posted Date  ICMJE November 20, 2015
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE November 17, 2011
Actual Primary Completion Date March 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score [ Time Frame: Baseline and Week 8 ]
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
Change from baseline to final on-therapy visit in the Children's depression rating scale, revised (CDRS-R) total score [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01372150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
  • Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: Baseline and Week 8 ]
    A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
  • Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 [ Time Frame: Baseline and Weeks 1, 2, 3, 4, 6, and 8 ]
    A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
  • Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
    A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • Clinical Global Impression Improvement (CGI-I) score at the final on-therapy visit [ Time Frame: 8 weeks ]
  • CGI-S score change from baseline at the final on-therapy visit [ Time Frame: 8 weeks ]
  • CGI-I response (1 or 2) [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Official Title  ICMJE A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
  • Drug: fluoxetine
    Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
  • Drug: placebo
    Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Study Arms  ICMJE
  • Experimental: DVS SR
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Fluoxetine
    Active control for assay sensitivity
    Intervention: Drug: fluoxetine
  • Experimental: Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
340
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
390
Actual Study Completion Date  ICMJE March 20, 2015
Actual Primary Completion Date March 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01372150
Other Study ID Numbers  ICMJE B2061014
3151A6-3356 ( Other Identifier: Alias Study Number )
2008-002063-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP