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DVS

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |Pfizer, Inc.|Trials Updated: Jul 27, 2017

DVS target and mechanism

ModalitySmall molecule

Also known as DVS SR

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials4
Total Enrollment1,839

FDA Designations

No designations recorded

DVS clinical trials

DVS · 4 trials · 2 indications

Phase 3 4
NCT01371708A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDDMajor Depressive Disorder
COMPLETED283 Analytics
NCT01371721A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDDMajor Depressive Disorder
COMPLETED269 Analytics
NCT00445679Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDDDepressive Disorder, Major
COMPLETED807 Analytics
NCT00277823Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED480 Analytics
PHASE3COMPLETED
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Depressive Disorder, MajorUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.

Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.

Percentage of Participants Experiencing a Treatment Emergent Adverse Event
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
8 weeks

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.

The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.

Secondary Endpoints

Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Desvenlafaxine Succinate Sustained-ReleaseEXPERIMENTAL -
AEXPERIMENTALDVS SR 50mg/day
BEXPERIMENTALDVS SR 100mg/day
CEXPERIMENTALDVS SR 200mg/day
DACTIVE_COMPARATORParoxetine 20mg/day

Interventions

NameTypeDescription
DVS SRDRUGSubjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
ParoxetineDRUG20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
DVS-SR 50 mgDRUG -
DVS-SR 100 mgDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range7 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR * Willingness and ability to comply with scheduled visits, treatment plan, and procedures Exclusion Criteria: * Requires precaution against suicide * Not in gen...

Countries:United StatesChileMexicoChinaIndiaSouth KoreaTaiwan
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Frequently asked questions about DVS

What is DVS used for?

DVS is used for the treatment of major depressive disorder. It has been studied in both adult and pediatric outpatients, including children and adolescents aged 7 years and older. The clinical program includes four completed Phase 3 trials with a total enrollment of 1,839 participants.

Who makes DVS?

DVS is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 3 clinical program evaluating DVS in major depressive disorder, including adult and pediatric studies conducted across multiple countries.

What phase is DVS in?

DVS is in Phase 3 clinical development for major depressive disorder. Four Phase 3 trials have been completed, and no active trials are currently listed. The completed studies enrolled a total of 1,839 participants and included randomized, double-blind, active-controlled designs.

What clinical trials is DVS in?

DVS has been evaluated in four completed Phase 3 trials: NCT01371721, NCT01371708, NCT00445679, and NCT00277823. These studies covered adult and pediatric outpatients with major depressive disorder and were conducted in countries including the United States, Mexico, Chile, China, India, South Korea, and Taiwan.

Is DVS the same as DVS SR?

Yes, DVS is also known as DVS SR and DVS-SR 50 mg. DVS SR refers to the sustained-release formulation of desvenlafaxine, which was studied in the Phase 3 clinical program for major depressive disorder. These names refer to the same investigational drug asset.