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DVS

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment807

FDA Designations

No designations recorded

Clinical trial landscape

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, also known as desvenlafaxine sustained-release, is an investigational small molecule being studied for the treatment of Major Depressive Disorder (MDD) in adult, child, and adolescent outpatients. It is being developed by Pfizer, Inc. (NYSE: PFE) and has completed Phase 3 clinical trials for this psychiatric condition.

What does DVS target?

DVS is a serotonin-norepinephrine reuptake inhibitor (SNRI) that works by blocking the reuptake of serotonin and norepinephrine in the brain, thereby increasing their levels in the synaptic cleft. This mechanism is believed to contribute to its antidepressant effects in treating Major Depressive Disorder.

Who makes DVS?

DVS is being developed by Pfizer, Inc., a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer has conducted multiple Phase 3 clinical trials evaluating DVS for the treatment of Major Depressive Disorder across various patient populations.

What phase is DVS in?

DVS is in Phase 3 clinical development. All three Phase 3 trials for DVS have been completed, with a total enrollment of 1,032 participants. These trials were randomized, double-blind, and active-controlled, studying the drug's efficacy and safety in treating Major Depressive Disorder.

What clinical trials is DVS in?

DVS has completed three Phase 3 trials: NCT00277823 (480 adults with MDD in the US), NCT00445679 (807 adults with MDD in China, India, South Korea, and Taiwan), and NCT01371708 (283 children and adolescents with MDD in the US and Chile). An additional trial, NCT01371721, enrolled 269 pediatric patients.

Is DVS the same as desvenlafaxine?

Yes, DVS is the same as desvenlafaxine sustained-release (DVS-SR). The drug is referred to as DVS in clinical trial documentation, and it is being studied as a treatment for Major Depressive Disorder in both adult and pediatric populations.