NCT00384033CompletedPhase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 638
- Locations
- 1
- Primary Endpoint
- Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Desvenlafaxine succinate sustained-release 50 mg
Experimental
Intervention: Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug)
Desvenlafaxine succinate sustained-release 100 mg
Experimental
Intervention: Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Duloxetine 60mg
Other
Active control to assess assay sensitivity
Intervention: Duloxetine 60 mg/day (Drug)
Outcomes
Primary Outcomes
Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation
Time Frame: Baseline and Week 8 or FOT
HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.
Secondary Outcomes
- Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation(Week 8 or FOT)
- Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
- Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation(Baseline and Week 8 or FOT)
Investigators
Study Sites (1)
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