Conditions: Depressive Disorder, Major
Keywords: Bupropion 323U66 Sustained Release (SR) MDD (Major Depressive Disorder) IVRS HAM-D IDS-SR MADRS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 572
Healthy volunteers: no

Brief summary:
This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.

Detailed description:

Arms:
arm 1: 323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening throughout the treatment phase. arm 2: 323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening during the first week of the treatment phase. At the second week, 323U66 SR 300mg cohort is up-titrated to a daily dose of 323U66 SR 300 mg, administered as 323U66 SR 150 mg tablet twice daily in the morning and in the evening, and the same daily dose is maintained to administer until the end of the treatment phase. arm 3: 323U66 SR placebo tablet is orally administered twice daily throughout the treatment phase.

Interventions: intervention 1: 323U66 SR 150 mg tablet intervention 2: 323U66 SR 150 mg placebo tablet
Intervention descriptions: intervention 1: 323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase. intervention 2: 323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.

Protocol document: