Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
A Randomized, Double-Blind, Parallel Group Study To Compare Discontinuation Symptoms In Abrupt Discontinuation Versus A 1-Week Tapering Regimen In Subjects With MDD Treated For 24 Weeks With Open-Label 50 mg DVS SR Formulation
2 other identifiers
interventional
480
0 countries
N/A
Brief Summary
Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Mar 2010
Shorter than P25 for phase_4 major-depressive-disorder
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
February 17, 2012
CompletedFebruary 28, 2012
October 1, 2011
11 months
January 22, 2010
January 31, 2012
February 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase
Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2\*mean(of DESSDB Week 1, DESSDB Week 2).
Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)
Secondary Outcomes (2)
Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase
Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)
Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms
Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)
Study Arms (3)
Desvenlafaxine Succinate Sustained-Release Formulation 50 mg
ACTIVE COMPARATORDesvenlafaxine Succinate Sustained-Release Formulation 25 mg
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
Eligibility Criteria
You may qualify if:
- Primary Diagnosis of Major Depressive Disorder
- Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline
You may not qualify if:
- Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder
- Potentially violent to others or is at significant risk for suicide
- History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion
- Known presence of raised intraocular pressure or history of narrow angle glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Publications (1)
Ninan PT, Musgnung J, Messig M, Buckley G, Guico-Pabia CJ, Ramey TS. Incidence and Timing of Taper/Posttherapy-Emergent Adverse Events Following Discontinuation of Desvenlafaxine 50 mg/d in Patients With Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 5;17(1):10.4088/PCC.14m01715. doi: 10.4088/PCC.14m01715. eCollection 2015.
PMID: 26137358DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 26, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 28, 2012
Results First Posted
February 17, 2012
Record last verified: 2011-10