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CompletedNCT01371734Updated Mar 20, 2017Results posted

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

A Phase 3 interventional study of Desvenlafaxine Succinate Sustained-Release and Desvenlafaxine Succinate Sustained-Release in Major Depressive Disorder, sponsored by Pfizer. Completed at 42 sites in 3 countries. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-03-20.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
363
Allocation
Randomized
Ages
7 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Major Depressive Disorder
  • MDD
  • Depression
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 363 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
363 participants (actual)

Study arms

  • Experimental
    Experimental Arm 1 - high dose

    Drug: Desvenlafaxine Succinate Sustained-Release

  • Experimental
    Experimental Arm 2 - low dose

    Drug: Desvenlafaxine Succinate Sustained-Release

  • Placebo comparator
    Placebo Arm

    Drug: Placebo

Interventions

  • DrugDesvenlafaxine 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.

  • DrugDesvenlafaxine 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.

  • DrugPlacebo

    Subjects randomized to the Placebo treatment arm will receive placebo tablets

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)

    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.

    Time frame: Baseline and Week 8

Secondary outcomes

  1. Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)

    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.

    Time frame: Baseline and Week 8

  2. Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at 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.

    Time frame: Weeks 1, 2, 3, 4, 6, and 8

  3. Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'

    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.

    Time frame: Weeks 1, 2, 3, 4, 6, and 8

07

Results

Posted Mar 20, 2017

Participant flow

Participant flow — Overall Study
MilestonePlaceboDVS SR Low DoseDVS SR High Dose
Started120122121
Completed97103104
Not completed231917
Withdrew: Other212
Withdrew: Withdrawal by subject349
Withdrew: Lost to follow-up531
Withdrew: Protocol violation312
Withdrew: Adverse event883
Withdrew: Lack of efficacy220

Outcome measures

PrimaryChange From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)

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.

Time frame:
Baseline and Week 8
Reported as:
Least squares mean · Score on a scale
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
Score on a scalePlaceboDVS SR Low DoseDVS SR High Dose
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)-22.85 ± 1.13-23.70 ± 1.12-24.37 ± 1.12
Statistical analysis
  • Placebo vs DVS SR Low Dose · Mixed-effects model for repeated measure · p = 0.587 · Mean difference (net): 0.85 · 95% CI -2.23 to 3.94Hochberg procedure was used to control for multiplicity
  • Placebo vs DVS SR High Dose · Mixed-effects model for repeated measure · p = 0.333 · Mean difference (net): 1.52 · 95% CI -1.56 to 4.61Hochberg procedure was used to control for multiplicity
SecondaryChange From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)

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.

Time frame:
Baseline and Week 8
Reported as:
Least squares mean · Score on a scale
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
Score on a scalePlaceboDVS SR Low DoseDVS SR High Dose
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)-1.49 ± 0.11-1.51 ± 0.11-1.65 ± 0.11
Statistical analysis
  • Placebo vs DVS SR Low Dose · Mixed-effects model for repeated measure · p = 0.923 · Mean difference (net): 0.015 · 95% CI -0.29 to 0.32Hochberg procedure was used to control for multiplicity
  • Placebo vs DVS SR High Dose · Mixed-effects model for repeated measure · p = 0.302 · Mean difference (net): 0.161 · 95% CI -0.14 to 0.47Hochberg procedure was used to control for multiplicity
SecondaryPercentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at 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.

Time frame:
Weeks 1, 2, 3, 4, 6, and 8
Reported as:
Number · Percentage of Participants
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Percentage of ParticipantsPlaceboDVS SR Low DoseDVS SR High Dose
Week 1, Very Much Improved (n=113, 112,115)2.70.92.6
Week 1, Much Improved (n=113, 112, 115)6.29.812.2
Week 1, Minimally Improved (n=113, 112, 115)38.937.533.9
Week 1, No Change (n=113, 112, 115)49.651.846.1
Week 1, Minimally Worse (n=113, 112, 115)2.705.2
Week 1, Much Worse (n=113, 112, 115)000
Week 1, Very Much Worse (n=113, 112, 115)000
Week 2, Very Much Improved (n=114, 115, 109)4.46.110.1
Week 2, Much Improved (n=114, 115, 109)26.326.123.9
Week 2, Minimally Improved (n=114, 115, 109)36.838.335.8
Week 2, No Change (n=114, 115, 109)31.625.229.4
Week 2, Minimally Worse (n=114, 115, 109)04.30
Week 2, Much Worse (n=114, 115, 109)0.900.9
Week 2, Very Much Worse (n=114, 115, 109)000
Week 3, Very Much Improved (n=108, 110, 110)10.210.918.2
Week 3, Much Improved (n=108, 110, 110)20.426.424.5
Week 3, Minimally Improved (n=108, 110, 110)47.244.535.5
Week 3, No Change (n=108, 110, 110)20.415.521.8
Week 3, Minimally Worse (n=108, 110, 110)1.91.80
Week 3, Much Worse (n=108, 110, 110)000
Week 3, Very Much Worse (n=108, 110, 110)00.90
Week 4, Very Much Improved (n=104,108,113)14.417.615.0
Week 4, Much Improved (n=104,108,113)30.836.131.0
Week 4, Minimally Improved (n=104,108,113)35.630.635.4
Week 4, No Change (n=104,108,113)19.214.817.7
Week 4, Minimally Worse (n=104,108,113)00.90.9
Week 4, Much Worse (n=104,108,113)000
Week 4, Very Much Worse (n=104,108,113)000
Week 6, Very Much Improved (n=106,104,104)19.820.226.9
Week 6, Much Improved (n=106,104,104)29.236.524.0
Week 6, Minimally Improved (n=106,104,104)31.124.031.7
Week 6, No Change (n=106,104,104)16.014.414.4
Week 6, Minimally Worse (n=106,104,104)2.82.91.9
Week 6, Much Worse (n=106,104,104)01.91.0
Week 6, Very Much Worse (n=106,104,104)0.900
Week 8, Very Much Improved (n=102,105,106)21.619.025.5
Week 8, Much Improved (n=102,105,106)34.337.136.8
Week 8, Minimally Improved (n=102,105,106)28.424.821.7
Week 8, No Change (n=102,105,106)15.718.115.1
Week 8, Minimally Worse (n=102,105,106)01.00.9
Week 8, Much Worse (n=102,105,106)000
Week 8, Very Much Worse (n=102,105,106)000
Statistical analysis
  • Placebo vs DVS SR Low Dose · Cochran-Mantel-Haenszel · p = 0.729
  • Placebo vs DVS SR High Dose · Cochran-Mantel-Haenszel · p = 0.756
  • Placebo vs DVS SR Low Dose · Cochran-Mantel-Haenszel · p = 0.765
  • Placebo vs DVS SR High Dose · Cochran-Mantel-Haenszel · p = 0.475
  • Placebo vs DVS SR Low Dose · Cochran-Mantel-Haenszel · p = 0.310
  • Placebo vs DVS SR High Dose · Chi-squared, Corrected · p = 0.105
  • Placebo vs DVS SR Low Dose · Cochran-Mantel-Haenszel · p = 0.254
  • Placebo vs DVS SR High Dose · Cochran-Mantel-Haenszel · p = 0.887
  • Placebo vs DVS SR Low Dose · Cochran-Mantel-Haenszel · p = 0.475
  • Placebo vs DVS SR High Dose · Cochran-Mantel-Haenszel · p = 0.407
  • Placebo vs DVS SR Low Dose · Cochran-Mantel-Haenszel · p = 0.696
  • Placebo vs DVS SR High Dose · Cochran-Mantel-Haenszel · p = 0.462
SecondaryPercentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'

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.

Time frame:
Weeks 1, 2, 3, 4, 6, and 8
Reported as:
Number · Percentage of Participants
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Percentage of ParticipantsPlaceboDVS SR Low DoseDVS SR High Dose
Week 1 (n=113, 112, 115)8.8510.7114.78
Week 2 (n=114, 115, 109)30.7032.1733.94
Week 3 (n=108, 110, 110)30.5637.2742.73
Week 4 (n=104, 108, 113)45.1953.7046.02
Week 6 (n=106, 104, 104)49.0656.7350.96
Week 8 (n=102, 105, 106)55.8856.1962.26
Statistical analysis
  • Placebo vs DVS SR Low Dose · Regression, Logistic · p = 0.633 · Odds ratio (or): 0.806 · 95% CI 0.333 to 1.951
  • Placebo vs DVS SR High Dose · Regression, Logistic · p = 0.172 · Odds ratio (or): 0.561 · 95% CI 0.245 to 1.285
  • Placebo vs DVS SR Low Dose · Regression, Logistic · p = 0.826 · Odds ratio (or): 0.939 · 95% CI 0.536 to 1.644
  • Placebo vs DVS SR High Dose · Regression, Logistic · p = 0.599 · Odds ratio (or): 0.860 · 95% CI 0.489 to 1.511
  • Placebo vs DVS SR Low Dose · Regression, Logistic · p = 0.248 · Odds ratio (or): 0.713 · 95% CI 0.402 to 1.265
  • Placebo vs DVS SR High Dose · Regression, Logistic · p = 0.048 · Odds ratio (or): 0.564 · 95% CI 0.320 to 0.995
  • Placebo vs DVS SR Low Dose · Regression, Logistic · p = 0.210 · Odds ratio (or): 0.708 · 95% CI 0.412 to 1.216
  • Placebo vs DVS SR High Dose · Regression, Logistic · p = 0.893 · Odds ratio (or): 0.964 · 95% CI 0.564 to 1.646
  • Placebo vs DVS SR Low Dose · Regression, Logistic · p = 0.228 · Odds ratio (or): 0.714 · 95% CI 0.413 to 1.235
  • Placebo vs DVS SR High Dose · Regression, Logistic · p = 0.751 · Odds ratio (or): 0.916 · 95% CI 0.531 to 1.579
  • Placebo vs DVS SR Low Dose · Regression, Logistic · p = 0.925 · Odds ratio (or): 0.974 · 95% CI 0.561 to 1.689
  • Placebo vs DVS SR High Dose · Regression, Logistic · p = 0.342 · Odds ratio (or): 0.764 · 95% CI 0.438 to 1.331

Adverse events

Collected over Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 8 for participants entering the extension study.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—2/120 (1.7%)34/120 (28.3%)
DVS SR Low Dose—2/122 (1.6%)46/122 (37.7%)
DVS SR High Dose—1/121 (0.8%)53/121 (43.8%)
Most frequent serious events
Most frequent serious events
EventPlaceboDVS SR Low DoseDVS SR High Dose
Suicide attemptPsychiatric disorders1/1201/1220/121
DermatomyositisSkin and subcutaneous tissue disorders1/1200/1220/121
AbscessInfections and infestations0/1200/1221/121
AppendicitisInfections and infestations0/1200/1221/121
AggressionPsychiatric disorders0/1201/1220/121
Most frequent other events
Most frequent other events
EventPlaceboDVS SR Low DoseDVS SR High Dose
HeadacheNervous system disorders15/12022/12225/121
NauseaGastrointestinal disorders7/12012/12214/121
Abdominal pain upperGastrointestinal disorders9/1207/12211/121
VomitingGastrointestinal disorders4/1201/1229/121
FatigueGeneral disorders2/1204/1229/121
NasopharyngitisInfections and infestations2/1208/1227/121
InsomniaPsychiatric disorders1/1207/1224/121

Baseline characteristics

Safety population - included all randomized participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(Years)PlaceboDVS SR Low DoseDVS SR High DoseTotal
Mean13.2 ± 2.6813.1 ± 2.8012.9 ± 3.0113.0 ± 2.83
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDVS SR Low DoseDVS SR High DoseTotal
Female606976205
Male605345158
08

Study locations

42 sites
  • Children's Hospital of Alabama Laboratory
    Birmingham, Alabama 35233, United States
  • The University of Alabama at Birmingham, Office of Psychiatric Research
    Birmingham, Alabama 35294, United States
  • Center for Advanced Improvement
    Tucson, Arizona 85719, United States
  • Sun Valley Research Center
    Imperial, California 92251, United States
  • MCB Clinical Research Centers
    Colorado Springs, Colorado 80910, United States
  • Bliss Basement Pharmacy - Hartford Hospital
    Hartford, Connecticut 06102, United States
  • Institute of Living/Hartford Hospital
    Hartford, Connecticut 06106, United States
  • Institute of Living
    Hartford, Connecticut 06106, United States
  • SJS Clinical Research, Inc.
    Destin, Florida 32541, United States
  • Sarkis Clinical Trials
    Gainesville, Florida 32607, United States
  • Clinical Neuroscience Solutions
    Jacksonville, Florida 32256, United States
  • Medical Research Group of Central Florida
    Orange City, Florida 32763, United States
  • Millenia Psychiatry & Research, Inc.
    Orlando, Florida 32839, United States
  • Janus Center for Psychiatric Research
    West Palm Beach, Florida 33407, United States
  • Northwest Behavioral Research Center
    Marietta, Georgia 30060, United States
  • Capstone Clinical Research
    Libertyville, Illinois 60048, United States
  • AMR-Baber Research Inc.
    Naperville, Illinois 60563, United States
  • Clinco
    Terre Haute, Indiana 47802, United States
  • Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic
    Shreveport, Louisiana 71103, United States
  • Drug:University Health Shreveport Outpatient
    Shreveport, Louisiana 71130, United States
  • Pharmasite Research Inc
    Baltimore, Maryland 21208, United States
  • Millennium Psychiatric Associates, LLC
    Creve Coeur, Missouri 63141, United States
  • Premier Psychiatric Research Institute, LLC
    Lincoln, Nebraska 68526, United States
  • Erie County Medical Center / State University of New York at Buffalo affiliate
    Buffalo, New York 14215, United States
  • The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
    Glen Oaks, New York 11004, United States
  • Bioscience Research, LLC.
    Mount Kisco, New York 10549, United States
  • Finger Lakes Clinical Research
    Rochester, New York 14618, United States
  • Stony Brook University Medical Center, Child And Adolescent Psychiatry
    Stony Brook, New York 11794-8790, United States
  • Neuro-Behavioral Clinical Research, Inc.
    Canton, Ohio 44718, United States
  • Discovery and Wellness Center for Children/University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Sooner Clinical Research
    Oklahoma City, Oklahoma 73112, United States
  • Research Strategies of Memphis, LLC.
    Memphis, Tennessee 38119, United States
  • FutureSearch Trials
    Austin, Texas 78731, United States
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
  • Alliance Research Group
    Richmond, Virginia 23230, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
  • Virginia Treatment Center
    Richmond, Virginia 23298, United States
  • Carilion Medical Center
    Roanoke, Virginia 24014, United States
  • Eastside Therapeutic Resource
    Kirkland, Washington 98033, United States
  • Biomedica Research Group
    Santiago, Region Metropolitana 7500710, Chile
  • Optima Salud
    Santiago, Region Metropolitana 8320325, Chile
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria
    Monterrey, Nuevo Leon 064460, Mexico
09

References and documents

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. PubMed 29185786 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01371734
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jun 13, 2011
Start date
Aug 2011
Primary completion
Sep 2015
Completion
Sep 2015
Results posted
Mar 20, 2017
Last update
Mar 20, 2017

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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