Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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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
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
* Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
* Drug: Placebo
* Drug: Duloxetine 60 mg/day


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desvenlafaxine succinate sustained-release 50 mg<br> | Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)<br>* 50 mg tablet, once daily dosing for 8 weeks<br>|
| Experimental: Desvenlafaxine succinate sustained-release 100 mg<br> | Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)<br>* 100 mg tablet, once daily dosing for 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo tablets and capsules, once daily dosing for 8 weeks<br>|
| Other: Duloxetine 60mg<br>Active control to assess assay sensitivity | Drug: Duloxetine 60 mg/day<br>* 60 mg capsule, once daily dosing for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation | 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. | Baseline and Week 8 or FOT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected. | Week 8 or FOT | 
| Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. | 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 | MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Baseline and Week 8 or FOT | 
| Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation | Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help. | Baseline and Week 8 or FOT | 
| Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation | HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe). | Baseline and Week 8 or FOT | 
| Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation | HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). | Baseline and Week 8 or FOT | 
| Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation | COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3. | 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 | VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI. | Baseline and Week 8 or FOT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD, Major Depressive Disorder, Depression