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A 10-month, open-label evaluation of desvenlafaxine in Japanese outpatients with major depressive disorder

Tourian, Karena; Wang, Yingb; Ii, Yoichic

International Clinical Psychopharmacology: July 2013 - Volume 28 - Issue 4 - p 206–213
doi: 10.1097/YIC.0b013e3283611d03
Original Articles

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.

aPfizer, Collegeville, Pennsylvania, USA

bHays Specialist Recruitment Japan KK

cPfizer Japan Inc., Tokyo, Japan

Correspondence to Yoichi Ii, PhD, Department of Clinical Statistics, Pfizer Japan Inc., Tokyo 151-8589, Japan Tel: +81 035 309 6881 x6881; fax: +81 035 309 9912; e-mail: yoichi.li@pfizer.com

Received August 28, 2012

Accepted March 11, 2013

© 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins