title: A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan.
abstract: The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75-225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (-10.76; P=0.031), but not in the flexible-dose (-10.37; P=0.106) group compared with placebo (-9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan.
authors.affiliation: aNational Center of Neurology and Psychiatry bClinical Research cMedical Affairs Global Established Pharma Business dClinical Statistics, Pfizer Japan Inc., Tokyo eInternational University of Health and Welfare, Tochigi, Japan.
authors.forename: Teruhiko
authors.initials: T
authors.lastname: Higuchi
authors.forename: Kunitoshi
authors.initials: K
authors.lastname: Kamijima
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Nakagome
authors.forename: Rio
authors.initials: R
authors.lastname: Itamura
authors.forename: Yuko
authors.initials: Y
authors.lastname: Asami
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Kuribayashi
authors.forename: Takayuki
authors.initials: T
authors.lastname: Imaeda
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011569:Psychiatric Status Rating Scales; D016728:Self-Injurious Behavior / Q000523:psychology; D059020:Suicidal Ideation; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D003692:Delayed-Action Preparations; D000069470:Venlafaxine Hydrochloride