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
Verified date | January 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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 |
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