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

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: desvenlafaxine succinate sustained-release
Drug: placebo

Registration Number: NCT01121484

Lead Sponsor: Pfizer

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 439

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:
1. an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
2. a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
3. a change in duration (absolute change of 2 or more days); or
4. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
desvenlafaxine succinate sustained-release	desvenlafaxine succinate sustained-release	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)	Week 8	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.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8	Baseline, 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.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8	Baseline, 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.
Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)	Baseline, Week 8	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.
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8	Baseline, 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.

Trial Locations

Locations (39): Birmingham Psychiatry Pharmaceutical Studies, Inc.
🇺🇸
Birmingham, Alabama, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
🇺🇸
Little Rock, Arkansas, United States
Pacific Clinical Research Medical Group
🇺🇸
Upland, California, United States
Southwestern Research, Inc.
🇺🇸
Beverly Hills, California, United States
Catalina Research Institute LLC
🇺🇸
Chino, California, United States
Western Affiliated Research Institute
🇺🇸
Denver, Colorado, United States
Radiant Research, Inc.
🇺🇸
San Antonio, Texas, United States
Connecticut Clinical Research
🇺🇸
Cromwell, Connecticut, United States
Comprehensive NeuroScience, Inc.
🇺🇸
St. Petersburg, Florida, United States
Stedman Clinical Trials, LLC
🇺🇸
Tampa, Florida, United States
Scroll for more (29 remaining)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
🇺🇸Birmingham, Alabama, United States