• Atul R Mahableshwarkar, Paula L Jacobsen, Yinzhong Chen, Michael Serenko, and Madhukar H Trivedi.
• CNS Medicine, Clinical Science, CNS Statistics, Pharmacovigilance, Takeda Development Center Americas, 1 Takeda Parkway, Deerfield, IL, 60015, USA, atul.mahableshwarkar@takeda.com.
• Psychopharmacology (Berl.). 2015 Jun 1;232(12):2061-70.

RationaleVortioxetine has reduced depressive symptoms in adults with major depressive disorder (MDD) in multiple clinical trials.ObjectivesThe aim of this study is to evaluate the efficacy, safety, and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD.MethodsPatients were randomized 1:1:1:1 to vortioxetine 15 mg, vortioxetine 20 mg, duloxetine 60 mg (active reference), or placebo. The primary efficacy endpoint was mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8 (MMRM). Safety/tolerability assessments included physical examinations, vital signs, laboratory evaluations, electrocardiograms, adverse events (AEs), Columbia-Suicide Severity Rating Scale, Arizona Sexual Experiences Scale, and Discontinuation-Emergent Signs and Symptoms checklist.ResultsSix hundred and fourteen patients were randomized. Mean changes in MADRS scores were -12.83 (±0.834), -14.30 (±0.890), -15.57 (±0.880), and -16.90 (±0.884) for placebo, vortioxetine 15 mg (P = .224), vortioxetine 20 mg (P = .023), and duloxetine 60 mg (P < .001) (P vs placebo), respectively. AEs reported by ≥5 % of vortioxetine patients included nausea, headache, diarrhea, dizziness, dry mouth, constipation, vomiting, insomnia, fatigue, and upper respiratory infection. Treatment-emergent sexual dysfunction, suicidal ideation or behavior, and discontinuation symptoms were not significantly different between vortioxetine and placebo.ConclusionsVortioxetine 20 mg significantly reduced MADRS total scores after 8 weeks of treatment. Both vortioxetine doses were well tolerated.Clinical Trial RegistrationClinicalTrials.gov identifier NCT01153009; www.clinicaltrials.gov/ .

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