Phase 4
Completed N=480
Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT01056289 ↗Enrolled (actual)
480
Serious AEs
0.6%
Results posted
Feb 2012
Primary outcomePrimary: Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase — 4.1; 4.8; 5.3 scores on a scale
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase |
4.1; 4.8; 5.3 | — |
| SECONDARY Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase |
35.6; 38.6; 50.7 | — |
| SECONDARY 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 |
1.4; 1.4; 1.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01056289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.