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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
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)
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 480 |
| Start date | 2010-03 |
| Completion | 2011-02 |
Conditions
- Major Depressive Disorder
Interventions
- Desvenlafaxine Succinate Sustained-Release Formulation 50 mg
- Desvenlafaxine Succinate Sustained-Release Formulation 25 mg
- Placebo
Primary outcomes
- Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase — 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).