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Koichiro Watanabe,1 Shinji Fujimoto,2 Tatsuro Marumoto,2 Tadayuki Kitagawa,3 Kazuyuki Ishida,3 Tadashi Nakajima,2 Yoshiya Moriguchi,4 Keita Fujikawa,2 Takeshi Inoue5 1Department of Neuropsychiatry, Kyorin University School of Medicine, Tokyo, Japan; 2Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan; 3Takeda Development Center – Japan, Takeda Pharmaceutical Co., Ltd, Osaka, Japan; 4Medical Affairs, Lundbeck Japan K.K., Tokyo, Japan; 5Department of Psychiatry, Tokyo Medical University, Tokyo, JapanCorrespondence: Koichiro Watanabe, Department of Neuropsychiatry, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan, Tel +81-422-47-5511, Fax +81-422-45-4697, Email koichiro@tke.att.ne.jpAim: Anhedonia in major depressive disorder may be resistant to first-line antidepressants. We examined the effect of vortioxetine, a multimodal antidepressant, on anhedonia-like symptoms in Japanese patients with major depressive disorder.Methods: This was a post hoc analysis of an 8-week, randomized, double-blind, placebo-controlled, phase 3 study of vortioxetine (10 mg or 20 mg) in Japanese patients aged 20– 75 years with recurrent major depressive disorder and a Montgomery–Åsberg Depression Rating Scale (MADRS) total score of at least 26. The primary outcome was the mean change from baseline to week 8 in anhedonia-like symptoms as measured by MADRS anhedonia factor score, composed of: Q1, apparent sadness; Q2, reported sadness; Q6, concentration; Q7, lassitude; and Q8, inability to feel. Mean change in MADRS total score and anhedonia factor score were compared among treatment groups, with data categorized by median baseline anhedonia factor score (0– 17 or ≥ 18).Results: Data were available for 489 patients. The least-squares mean difference in MADRS anhedonia factor score change from baseline to week 8 versus placebo was − 1.34 for vortioxetine 10 mg (P = 0.0300) and − 1.77 for vortioxetine 20 mg (P = 0.0044). The leas

Background: Major depressive disorder (MDD) is highly prevalent in Japan and frequently accompanied by insomnia that may persist even with MDD remission. Hypnotics are used for the pharmacological treatment of insomnia, but their influence on MDD recurrence or residual insomnia following MDD remission is unclear. This retrospective, longitudinal, cohort study utilized a large Japanese health insurance claims database to investigate patterns of hypnotic prescriptions among patients with MDD, and the influence of hypnotic prescription pattern on MDD recurrence. Methods: Eligible patients (20–56 years) were those registered in the Japan Medical Data Center database between 1 January 2005 and 31 December 2018, and prescribed antidepressant and hypnotic therapy after being diagnosed with MDD. Patients who had ceased antidepressant therapy for > 180 days were followed for 1 year to evaluate depression recurrence, as assessed using Kaplan-Meier estimates. Logistic regression modelling was used to analyze the effect of hypnotic prescription pattern on MDD recurrence. Results: Of the 179,174 patients diagnosed with MDD who initiated antidepressant treatment between 1 January 2006 and 30 June 2017, complete prescription information was available for 2946 eligible patients who had been prescribed hypnotics. More patients were prescribed hypnotic monotherapy (70.8%) than combination therapy (29.2%). The most prescribed therapies were benzodiazepine monotherapy (26.2%), non-benzodiazepine monotherapy (28.9%), and combination therapy with two drugs (21.1%). Among patients prescribed multiple hypnotics, concomitant prescriptions for anxiolytics, antipsychotics, mood stabilizers and sedative antidepressants were more common. The 1-year recurrence rate for MDD was approximately 20%, irrespective of hypnotic monoversus combination therapy or class of hypnotic therapy. Being a spouse (odds ratio [OR], 1.44; 95% confidence interval [CI], 1.03–2.02) or other family member (OR, 1.46, 95%

Takeshi Inoue,1 Shinji Fujimoto,2 Tatsuro Marumoto,2 Tadayuki Kitagawa,3 Kazuyuki Ishida,3 Tadashi Nakajima,2 Yoshiya Moriguchi,4 Keita Fujikawa,2 Koichiro Watanabe5 1Department of Psychiatry, Tokyo Medical University, Tokyo, Japan; 2Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan; 3Takeda Development Center – Japan, Takeda Pharmaceutical Co., Ltd, Osaka, Japan; 4Medical Affairs, Lundbeck Japan K.K., Tokyo, Japan; 5Department of Neuropsychiatry, Kyorin University School of Medicine, Tokyo, JapanCorrespondence: Takeshi InoueDepartment of Psychiatry, Tokyo Medical University, 6‐7‐1 Nishishinjuku, Shinjuku‐ku, Tokyo, 160‐0023, JapanTel +81-3-3342-6111 (ext. 5754)Fax +81-3-3340-4499Email tinoue@tokyo-med.ac.jpAim: Antidepressants, including selective serotonin reuptake inhibitors, often elicit a poor response in patients with major depressive disorder (MDD) with significant anxiety symptoms. This study investigated the effects of the multimodal antidepressant vortioxetine in patients with MDD and associated anxiety.Methods: This was a post hoc analysis of data from an 8-week, randomized, double-blind, placebo-controlled, Phase 3 study of vortioxetine (10 mg or 20 mg) in Japanese patients aged 20– 75 years with recurrent MDD and a Montgomery–Åsberg Depression Rating Scale (MADRS) score of at least 26. Changes from baseline to week 8 in MADRS total score and Hamilton Depression Rating Scale (HAM-D) anxiety/somatization factor score were assessed in patients with anxious depression (HAM-D anxiety/somatization factor score ≥ 7) and without anxious depression.Results: Data were available for 489 patients. In patients with anxious depression, the least-squares (LS) mean difference (95% confidence interval [CI]) versus placebo in change in MADRS total score was − 3.44 (− 6.10, − 0.77) for vortioxetine 10 mg and − 4.51 (− 7.15, − 1.87) for vortioxetine 20 mg. In patients with non-anxious depression, the LS mean difference (95% CI)

Takeshi Inoue,1 Shinji Fujimoto,2 Tatsuro Marumoto,2 Tadayuki Kitagawa,3 Kazuyuki Ishida,3 Tadashi Nakajima,2 Yoshiya Moriguchi,4 Keita Fujikawa,2 Koichiro Watanabe5 1Department of Psychiatry, Tokyo Medical University, Tokyo, Japan; 2Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan; 3Takeda Development Center – Japan, Takeda Pharmaceutical Co., Ltd, Osaka, Japan; 4Medical Affairs, Lundbeck Japan K.K., Tokyo, Japan; 5Department of Neuropsychiatry, Kyorin University School of Medicine, Tokyo, JapanCorrespondence: Takeshi InoueDepartment of Psychiatry, Tokyo Medical University, 6‐7‐1 Nishishinjuku, Shinjuku‐ku, Tokyo, 160‐0023, JapanTel +81-3-3342-6111 (ext. 5754)Fax +81-3-3340-4499Email tinoue@tokyo-med.ac.jpAim: Several weeks of treatment with an antidepressive agent may be required before efficacy is demonstrated in patients with major depressive disorder. This study investigated the predictive value of early partial improvement with vortioxetine for treatment response and remission.Methods: This was a post hoc analysis of an 8-week, randomized, double-blind, placebo-controlled, Phase 3 study of vortioxetine (10 mg or 20 mg) in Japanese patients aged 20– 75 years with recurrent major depressive disorder and a Montgomery–Åsberg Depression Rating Scale (MADRS) score of at least 26. The key outcomes were the predictive value of early partial improvement (reduction in MADRS total score of ≥ 20% from baseline to week 2) with vortioxetine for MADRS response (≥ 50% decrease in score from baseline) and remission (decrease in score to ≤ 10) at week 8.Results: Relevant data were available for 478 patients; 62/158 patients receiving placebo, 71/162 receiving vortioxetine 10 mg, and 66/158 receiving vortioxetine 20 mg were early improvers. Early improvers receiving vortioxetine (10 mg or 20 mg) were more likely than non-early improvers to achieve a week 8 response (71.2– 73.2% vs 29.7– 38.0%) or remission (50.7– 51.5% vs 17.4– 18.7