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Trial record 1 of 1 for:    NCT01371734
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A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

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ClinicalTrials.gov Identifier: NCT01371734
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
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 March 7, 2016
Results First Posted Date  ICMJE March 20, 2017
Last Update Posted Date March 20, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) [ 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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
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 NCT01371734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106) [ 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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
  • Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 [ 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 equals (=) 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) or 2 (much improved) on the scale. Higher score = more affected.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
  • Clinical Global Impressions Improvement (CGI-I) Score at the final on-therapy visit [ Time Frame: 8 weeks ]
  • Clinical Global Impressions Severity Score at the final on-therapy visit [ Time Frame: 8 weeks ]
  • Clinical Global Impression Improvement Response (score 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, 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 Sustained-Release (DVS SR) versus 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 treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
  • 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.
  • Drug: Placebo
    Subjects randomized to the Placebo treatment arm will receive placebo tablets
Study Arms  ICMJE
  • Experimental: Experimental Arm 1 - high dose
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release
  • Experimental: Experimental Arm 2 - low dose
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release
  • Placebo Comparator: Placebo Arm
    Intervention: Drug: Placebo
Publications * Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29.

*   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: December 1, 2015)
363
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
390
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 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 behavior 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 Chile,   Mexico,   United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01371734
Other Study ID Numbers  ICMJE B2061032
3151A6-3343 ( Other Identifier: Alias Study Number )
2008-001875-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 2017

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