Phase 3
Completed N=638
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT00384033 ↗
Enrolled (actual)
638
Serious AEs
1.1%
Results posted
Mar 2012
Primary outcomePrimary: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation — -8.68; -9.75; -10.5; -10.3 Units on a Scale — p=0.198
Summary
The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation |
-8.68; -9.75; -10.5; -10.3 | 0.198 |
| SECONDARY Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation |
31; 27; 45; 45; 32; 38 | 0.110 |
| SECONDARY Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation |
-1.10; -1.25; -1.44; -1.41 | 0.248 |
| SECONDARY Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation |
31.10; 30.10; 30.70; 30.80; -11.00; -12.70 | 0.149 |
| SECONDARY Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation |
3.49; 3.53; 3.70; 3.50; -1.27; -1.39 | 0.473 |
| SECONDARY Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation |
13.00; 12.80; 12.90; 12.90; -4.82; -5.41 | 0.215 |
| SECONDARY Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation |
8.38; 8.43; 8.51; 8.38; -3.13; -3.66 | 0.100 |
| SECONDARY Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation |
6.50; 6.30; 6.30; 6.30; -1.02; -1.15 | 0.445 |
| SECONDARY Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation |
26.30; 30.80; 25.90; 26.10; 16.70; 19.40 | 0.124 |
Eligibility Criteria
Inclusion Criteria
- A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
- Depressive symptoms for at least 30 days before the screening visit.
- Outpatient men and women at least 18 years of age.
Exclusion Criteria
- 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.
- Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
Data sourced from ClinicalTrials.gov (NCT00384033). 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.