Clinical trial NCT00369343: Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Official title: A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Depressive Disorder
Depressive Disorder, Major
Keywords: Major Depressive Disorder
vasomotor symptoms
menopause
diabetic neuropathy
fibromyalgia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 381
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: Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.


Eligibility criteria: Inclusion Criteria:

* Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.
* A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).
* Montgomery-Asberg Depression Rating Scale (MADRS) total score \> or = 22 at the screening and baseline visit.

Exclusion Criteria:

* Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
* Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* A history or active presence of clinically important medical disease.

Additional criteria apply.

Primary outcomes:
measure: Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
timeFrame: 8 weeks
measure: Percentage of Patients Achieving Remission
timeFrame: 8 weeks
measure: Percentage of Patients Achieving Response to Treatment
timeFrame: 8 weeks
measure: Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8
timeFrame: Baseline to 8 weeks
measure: Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
timeFrame: Baseline to 8 weeks
measure: Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months
timeFrame: open label baseline and 6 months
measure: Clinical Global Impression Improvement (CGI-I) Score
timeFrame: 6 months
measure: Percentage of Patients Achieving Remission
timeFrame: 6 months
measure: Percentage of Patients Achieving a Response to Treatment
timeFrame: 6 months
measure: Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months
timeFrame: open label baseline to 6 months
measure: Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months
timeFrame: open label baseline to 6 months
measure: Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Springdale
country: United States
state: Arkansas
city: Palo Alto
country: United States
state: California
city: San Diego
country: United States
state: California
city: New London
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Sandy Springs
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Terre Haute
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Rockville
country: United States
state: Maryland
city: Omaha
country: United States
state: Nebraska
city: Cherry Hill
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Minot
country: United States
state: North Dakota
city: Beachwood
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Hilton Head Island
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Brown Deer
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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: Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010 Aug;71(8):1088-96. doi: 10.4088/JCP.10m06018blu.