Conditions: Depressive Disorder, Major
Keywords: major depressive disorder MDD depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 807
Healthy volunteers: no

Brief summary:
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

Detailed description:
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.

Arms:
arm 1: DVS SR 50mg/day arm 2: DVS SR 100mg/day arm 3: DVS SR 200mg/day arm 4: Paroxetine 20mg/day

Interventions: intervention 1: DVS SR intervention 2: Paroxetine
Intervention descriptions: intervention 1: Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper intervention 2: 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

Protocol document: