Phase 3
Completed N=807
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT00445679 ↗
Enrolled (actual)
807
Serious AEs
1.5%
Results posted
Nov 2013
Primary outcomePrimary: Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) — 63; 67; 63; 66 percentage of responders
Summary
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) |
63; 67; 63; 66 | — |
| SECONDARY Clinical Global Impressions Scale-Improvement (CGI-I) Scores |
72; 78; 79; 72; 64; 64 | 0.714 |
| SECONDARY Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores |
40; 50; 53; 42; 49; 53 | 0.450 |
| SECONDARY Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline |
-16.84; -17.84; -16.81; -16.54 | — |
| SECONDARY Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline |
-11.69; -10.00; -9.10; -9.52 | — |
| SECONDARY Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline |
-6.50; -6.51; -6.42; -6.58 | — |
| SECONDARY Covi Anxiety Scale Score Mean Change From Baseline |
-1.23; -1.28; -1.17; -1.24 | — |
Eligibility Criteria
Primary Inclusion Criteria:
- Outpatient men and women at least 18 years of age.
- Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
- Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
Primary Exclusion Criteria:
- Treatment with DVS SR at any time in the past.
- Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
- Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Data sourced from ClinicalTrials.gov (NCT00445679). 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.