title: A 10-month, open-label evaluation of desvenlafaxine in Japanese outpatients with major depressive disorder.
abstract: The objective of this study was to evaluate the long-term safety of desvenlafaxine for continuation treatment of major depressive disorder (MDD) in Japanese patients. This was a phase 3, multicenter, 10-month, open-label study with flexible dosing of desvenlafaxine (25, 50, 100 mg/day). Japanese patients with MDD who had completed an 8-week, double-blind, placebo-controlled study in which patients received 25 or 50 mg/day desvenlafaxine or placebo were enrolled. In this study, patients received desvenlafaxine 25 mg/day from days 1 to 14, with subsequent upward titration, to a maximum of 100 mg/day, determined by clinical response. Of 304 patients, 75 (24.7%) discontinued during the on-therapy period; patient request was the most common reason (11.5%). Treatment-emergent adverse events were reported by 240 patients (78.9%) during the on-therapy period; the most common adverse events were nasopharyngitis (37.2%), somnolence (11.5%), headache (10.5%), and nausea (10.2%). For the ITT-LOCF population, the mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D₁₇) total score was -4.76 (95% confidence interval: -5.47 to -4.05); continued numerical improvements in the HAM-D₁₇ total scores and other depression outcome measures were observed irrespective of treatment in the previous study. Long-term use of desvenlafaxine was safe and well tolerated, with a clinical benefit/risk profile similar to that in other populations.
authors.affiliation: Pfizer, Collegeville, Pennsylvania, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Tourian
authors.forename: Ying
authors.initials: Y
authors.lastname: Wang
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Ii
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003511:Cyclohexanols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000188:drug therapy*; D000069468:Desvenlafaxine Succinate; D039721:Diagnostic and Statistical Manual of Mental Disorders; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced / Q000453:epidemiology; D016903:Drug Monitoring; D005260:Female; D006261:Headache / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D057194:Intention to Treat Analysis; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D014179:Neurotransmitter Uptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales
chemical_list: D000928:Antidepressive Agents; D003511:Cyclohexanols; D014179:Neurotransmitter Uptake Inhibitors; D000069468:Desvenlafaxine Succinate