Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

Completed · Phase 3 · Has a placebo group

Conditions studied: Depression, Depressive Disorder, Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT00369343

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

381

Starts

2006-09-01

Expected to finish

2008-07-01

Last updated by the study team

2012-05-07

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Springdale, Arkansas, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — New London, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Sandy Springs, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Terre Haute, Indiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Rockville, Maryland, United States
• Study site — Omaha, Nebraska, United States
• Study site — Cherry Hill, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Minot, North Dakota, United States
• Study site — Beachwood, Ohio, United States

Full record on ClinicalTrials.gov

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