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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 480
- Primary Endpoint
- Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary Diagnosis of Major Depressive Disorder
- •Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline
Exclusion Criteria
- •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
Arms & Interventions
Desvenlafaxine Succinate Sustained-Release Formulation 50 mg
Intervention: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg (Drug)
Desvenlafaxine Succinate Sustained-Release Formulation 25 mg
Intervention: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase
Time Frame: Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)
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).
Secondary Outcomes
- 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))