PMID- 24039429 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20130916 LR - 20220316 IS - 1176-6328 (Print) IS - 1178-2021 (Electronic) IS - 1176-6328 (Linking) VI - 9 DP - 2013 TI - The efficacy and safety of bupropion sustained-release formulation for the treatment of major depressive disorder: a multi-center, randomized, double-blind, placebo-controlled study in Asian patients. PG - 1273-80 LID - 10.2147/NDT.S48158 [doi] AB - This study was conducted to compare the efficacy and safety of bupropion sustained-release (SR) formulation orally administered at daily doses of 150 mg/day (once daily) and 300 mg/day (150 mg twice daily) for 8 weeks versus placebo in Asian patients with major depressive disorder. The mean change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at week 8 was compared between each of the bupropion SR dose groups and the placebo group using an analysis of covariance with the multiplicity adjustment by Dunnett's step-down procedure. A total of 569 subjects met all of the inclusion criteria and proceeded to the treatment phase. The subjects proceeding to the treatment phase included 454 Japanese patients and 115 Korean patients. There was no statistically significant difference between each of the bupropion SR dose groups and the placebo group in the primary efficacy endpoint of change from baseline in MADRS total score at week 8. Similar results were generally obtained for all of the secondary efficacy endpoints. The secondary analysis and the other subgroup analysis did not show a statistically significant difference in efficacy. There was no substantial difference in the type, severity, and incidence of adverse events (AEs) between the bupropion SR dose groups and the placebo group, which indicates a favorable safety profile for bupropion SR. There were no significant findings in subjects treated with bupropion SR in regard to sexual dysfunction, weight change, and withdrawal syndrome, which are frequently recognized as clinical concerns associated with selective serotonin reuptake inhibitors, widely used for the treatment of depression. FAU - Koshino, Yoshifumi AU - Koshino Y AD - Iris Medical Clinic, Kanazawa University, Ishikawa, Japan. FAU - Bahk, Won-Myong AU - Bahk WM FAU - Sakai, Hideaki AU - Sakai H FAU - Kobayashi, Takayuki AU - Kobayashi T LA - eng PT - Journal Article DEP - 20130828 PL - New Zealand TA - Neuropsychiatr Dis Treat JT - Neuropsychiatric disease and treatment JID - 101240304 PMC - PMC3770623 OTO - NOTNLM OT - Japan OT - Korea OT - bupropion SR OT - major depressive disorder OT - placebo EDAT- 2013/09/17 06:00 MHDA- 2013/09/17 06:01 PMCR- 2013/08/28 CRDT- 2013/09/17 06:00 PHST- 2013/09/17 06:00 [entrez] PHST- 2013/09/17 06:00 [pubmed] PHST- 2013/09/17 06:01 [medline] PHST- 2013/08/28 00:00 [pmc-release] AID - ndt-9-1273 [pii] AID - 10.2147/NDT.S48158 [doi] PST - ppublish SO - Neuropsychiatr Dis Treat. 2013;9:1273-80. doi: 10.2147/NDT.S48158. Epub 2013 Aug 28.