Phase 3
Completed N=427
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT00824291 ↗
Enrolled (actual)
427
Serious AEs
0.9%
Results posted
Nov 2010
Primary outcomePrimary: Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 — -12.61; -10.50 Scores on a scale — p=0.002
Summary
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 |
-12.61; -10.50 | 0.002 sig |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12 |
-9.41; -8.08 | 0.067 |
| SECONDARY Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12 |
103; 31; 84; 44; 53; 31 | 0.001 sig |
| SECONDARY Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12 |
69; 23; 68; 30; 77; 31 | 0.002 sig |
| SECONDARY Change From Baseline on Work and Activities Item of HAM-D17 at Week 12 |
-1.68; -1.45 | 0.040 sig |
| SECONDARY Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12 |
-18.44; -16.18 | 0.035 sig |
| SECONDARY Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12 |
-13.39; -10.95 | 0.041 sig |
| SECONDARY Change From Baseline on Stress and Social Support Scales at Week 12 |
-2.53; -2.14 | 0.145 |
Eligibility Criteria
Inclusion Criteria
- Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
- Employed for 20 hours or more for a minimum of 1 month prior to baseline.
- Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.
Exclusion Criteria
- Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
- Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
- Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
Data sourced from ClinicalTrials.gov (NCT00824291). 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.