Clinical trial NCT01121484: Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 439
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 8
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)
timeFrame: Baseline, Week 8
measure: Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Arcadia
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Beverly Hills
country: United States
facility: Southwestern Research, Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute LLC
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Cromwell
country: United States
facility: Connecticut Clinical Research
state: Connecticut
city: St. Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Emory University Department of Psychiatry and Behavioral Sciences
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Newburgh
country: United States
facility: Deaconess Clinic Gateway Health Center Research Institute
state: Indiana
city: Witchita
country: United States
facility: Via Christi Research
state: Kansas
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, P.C.
state: Michigan
city: Las Vegas
country: United States
facility: Radiant Research, Inc.
state: Nevada
city: Cherry Hill
country: United States
facility: Center For Emotional Fitness
state: New Jersey
city: Piscataway
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research PC
state: New York
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Bismarck
country: United States
facility: Horizon Medical Services, PC
state: North Dakota
city: Bismark
country: United States
facility: Legacy Pharma Research
state: North Dakota
city: Beechwood
country: United States
facility: North Coast Clinical Trials, Inc.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Columbia
country: United States
facility: Carolina Clinical Research Services, LLC
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Houston
country: United States
facility: Bayou City Research, Ltd.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System Center for Psychiatric Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Nelson Clinic
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Waukesha
country: United States
facility: Independent Psychiatric Consultants, SC dba IPC Research
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.
citation: Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.
citation: McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
citation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.
citation: Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900.
citation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
citation: Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.
citation: Clayton AH, Kornstein SG, Dunlop BW, Focht K, Musgnung J, Ramey T, Bao W, Ninan PT. Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2013 Oct;74(10):1010-7. doi: 10.4088/JCP.12m08065.