title: Safety, tolerability, and efficacy of vortioxetine (Lu AA21004) in major depressive disorder: results of an open-label, flexible-dose, 52-week extension study.
abstract: Patients with major depressive disorder often experience relapse after responding to treatment; therefore, maintenance therapy with antidepressants is recommended for maintaining response or remission. This multicenter, open-label, flexible-dose, 52-week extension study evaluated the long-term safety, tolerability, and maintenance of efficacy in study participants who had completed one of two randomized, double-blind, placebo-controlled, 8-week dose-ranging vortioxetine trials in study participants with major depressive disorder. At the open-label baseline, all study participants were switched to vortioxetine 5 mg/day for the first week, with subsequent dose adjustments from 2.5 to 10 mg/day on the basis of response and tolerability. Treatment with vortioxetine for 52 weeks was well tolerated, with no new safety signals identified. Among the 834 evaluable study participants, treatment-emergent adverse events were reported in 70.6%, with the most common in the combined (all doses) population of nausea (15.2%), headache (12.4%), nasopharyngitis (9.8%), diarrhea (7.2%), and dizziness (6.8%). The rate of adverse events related to sexual dysfunction was low and weight gain was minimal. Laboratory values, vital signs, ECGs, physical examinations, and Columbia-Suicide Severity Rating Scale results showed no trends of clinical concern. The change in the severity of depressive and anxiety symptoms was maintained throughout the study as reflected by a 24-item Hamilton Depression Scale total score of 8.2 at week 52 (from 17.6 at open-label baseline) in the observed case data set.
authors.affiliation: aAmerican Medical Research Inc., Oak Brook bTakeda Development Center Americas, Deerfield, Illinois, USA.
authors.forename: Mohammed Y
authors.initials: MY
authors.lastname: Alam
authors.forename: Paula L
authors.initials: PL
authors.lastname: Jacobsen
authors.forename: Yinzhong
authors.initials: Y
authors.lastname: Chen
authors.forename: Michael
authors.initials: M
authors.lastname: Serenko
authors.forename: Atul R
authors.initials: AR
authors.lastname: Mahableshwarkar
mesh_terms: D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000523:psychology; D003863:Depression / Q000523:psychology; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced; D059020:Suicidal Ideation; D013440:Sulfides / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use; D016896:Treatment Outcome; D000078784:Vortioxetine; D015430:Weight Gain / Q000187:drug effects; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D010879:Piperazines; D013440:Sulfides; D013876:Thiophenes; D000078784:Vortioxetine; D000068736:Duloxetine Hydrochloride