Conditions: Major Depressive Disorder
Keywords: Venlafaxine ER long-term extension Japan
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Venlafaxine ER
Intervention descriptions: intervention 1: Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration

Protocol document: