Phase 4
N=924
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01432457 ↗Enrolled (actual)
924
Serious AEs
1.1%
Results posted
Jan 2014
Primary outcome: Primary: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 — -9.71; -11.28; -11.67 Units on a scale — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- desvenlafaxine succinate sustained-release 50 mg/day (Drug); desvenlafaxine succinate sustained-release 100 mg/day (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 |
-9.50; -10.86; -11.16 | 0.014 sig |
| PRIMARY Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 |
-9.50; -10.86; -11.16 | 0.014 sig |
| SECONDARY Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) |
55; 57; 81; 76; 104; 98 | 0.029 sig |
| SECONDARY Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) |
-1.27; -1.47; -1.55 | 0.009 sig |
| SECONDARY Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score |
-1.21; -1.38; -1.43 | 0.062 |
| SECONDARY Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate |
39.46; 45.02; 47.51 | 0.198 |
| SECONDARY Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate |
21.77; 24.05; 28.57 | 0.615 |
| SECONDARY Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score |
-0.45; -0.35; -0.13 | 0.837 |
Summary
A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
- A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
- A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.
Exclusion Criteria
- Significant risk of suicide based on clinical judgment.
- 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.
- Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
- History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
- Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
Data sourced from ClinicalTrials.gov (NCT01432457). 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.