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

Wyeth

Status and phase

Completed

Phase 3

Conditions

Depressive Disorder, Major

Depression

Depressive Disorder

Treatments

Drug: Placebo

Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00369343

3151A1-403

Details and patient eligibility

About

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.

Enrollment

381 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.