Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: desvenlafaxine succinate sustained release
* Genetic: Genotyping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: desvenlafaxine succinate sustained release<br>* 50 mg/day oral tablet for 12 weeks<br>* Other names: Pristiq;|
| Experimental: 2<br> | Genetic: Genotyping<br>* CYP2D6 genotyping at randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 | HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline. | At Baseline and Week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12 | Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10. | At Baseline and Week 12. | 
| Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12 | 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. Higher score = more affected. Change = score at observation minus score at baseline. | At Baseline and Week 12. | 
| Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12 | 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 patients). Higher score = more affected. Change: score at observation minus score at baseline. | At Baseline and Week 12. | 
| Change From Baseline on Work and Activities Item of HAM-D17 at Week 12 | The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4. | At Baseline and Week 12. | 
| Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12 | 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). | At Baseline and Week 12. | 
| Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12 | WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing. | At Baseline and Week 12. | 
| Change From Baseline on Stress and Social Support Scales at Week 12 | Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends. | At Baseline and Week 12. | 

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