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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121484
• Other study ID #: 3151A1-3364
• Secondary ID: B2061029
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2010
• Last updated: March 30, 2012
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• desvenlafaxine succinate sustained-release
50-mg DVS SR tablets taken orally once daily.
• placebo
Placebo tablets taken orally once daily.

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Pacific Clinical Research Medical Group	Arcadia	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Emory University Department of Psychiatry and Behavioral Sciences	Atlanta	Georgia
United States	North Coast Clinical Trials, Inc.	Beechwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Southwestern Research, Inc.	Beverly Hills	California
United States	Birmingham Psychiatry Pharmaceutical Studies, Inc.	Birmingham	Alabama
United States	Horizon Medical Services, PC	Bismarck	North Dakota
United States	Legacy Pharma Research	Bismark	North Dakota
United States	Holston Medical Group	Bristol	Tennessee
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Metrolina Medical Research	Charlotte	North Carolina
United States	University of Virginia Health System Center for Psychiatric Clinical Research	Charlottesville	Virginia
United States	Center For Emotional Fitness	Cherry Hill	New Jersey
United States	Catalina Research Institute LLC	Chino	California
United States	Carolina Clinical Research Services, LLC	Columbia	South Carolina
United States	Connecticut Clinical Research	Cromwell	Connecticut
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	Western Affiliated Research Institute	Denver	Colorado
United States	Bayou City Research, Ltd.	Houston	Texas
United States	Westside Family Medical Center, P.C.	Kalamazoo	Michigan
United States	Holston Medical Group	Kingsport	Tennessee
United States	Radiant Research, Inc.	Las Vegas	Nevada
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	Medical & Behavioral Health Research PC	New York	New York
United States	Deaconess Clinic Gateway Health Center Research Institute	Newburgh	Indiana
United States	Pacific Clinical Research Medical Group	Orange	California
United States	Robert Wood Johnson Medical School	Piscataway	New Jersey
United States	Summit Research Network (Oregon), Inc.	Portland	Oregon
United States	Nelson Clinic	Richmond	Virginia
United States	Northwest Behavioral Research Center	Roswell	Georgia
United States	Radiant Research, Inc.	San Antonio	Texas
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Carman Research	Smyrna	Georgia
United States	Comprehensive NeuroScience, Inc.	St. Petersburg	Florida
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Independent Psychiatric Consultants, SC dba IPC Research	Waukesha	Wisconsin
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Via Christi Research	Witchita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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