Conditions: Major Depressive Disorder
Keywords: Open-label Long-term extension study
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 304
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD).

The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

Detailed description:

Arms:
arm 1: DVS SR

Interventions: intervention 1: desvenlafaxine succinate sustained release tablets
Intervention descriptions: intervention 1: 25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.

Protocol document: