Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)

Study Overview
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Brief Summary
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A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder

Official Title
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A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: desvenlafaxine succinate sustained-release
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English. Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline: an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline; a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy); a change in duration (absolute change of 2 or more days); or periods of amenorrhea lasting at least 3 months. A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI). A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline. Exclusion Criteria: Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline. Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy). 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. Known presence of raised intraocular pressure or history of narrow-angle glaucoma.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Experimental: desvenlafaxine succinate sustained-release<br> | Drug: desvenlafaxine succinate sustained-release<br>* 50-mg DVS SR tablets taken orally once daily.<br>* Other names: Pristiq;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Placebo tablets taken orally once daily.<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-D17) at Week 8 | HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline. | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Week 8 | 
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8 | 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. | Baseline, Week 8 | 
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8 | 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). Change: score at observation minus score at baseline. | Baseline, Week 8 | 
| Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR) | This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline. | Baseline, Week 8 | 
| Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8 | 10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline. | Baseline, Week 8 |