vortioxetine and Sleep-Initiation-and-Maintenance-Disorders

Vortioxetine has reduced depressive symptoms in adults with major depressive disorder (MDD) in multiple clinical trials.. The aim of this study is to evaluate the efficacy, safety, and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD.. Patients 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.. Six 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.. Vortioxetine 20 mg significantly reduced MADRS total scores after 8 weeks of treatment. Both vortioxetine doses were well tolerated.. ClinicalTrials.gov identifier NCT01153009; www.clinicaltrials.gov/ .

Topics: Adolescent; Adult; Aged; Antidepressive Agents; Depressive Disorder, Major; Dose-Response Relationship, Drug; Double-Blind Method; Duloxetine Hydrochloride; Electrocardiography; Fatigue; Female; Humans; Male; Middle Aged; Piperazines; Psychiatric Status Rating Scales; Selective Serotonin Reuptake Inhibitors; Sleep Initiation and Maintenance Disorders; Suicidal Ideation; Sulfides; Vortioxetine; Young Adult

Insomnia is a frequent symptom in depressed patients. It can present with difficulty in initiating and/or maintaining sleep. We retrospectively evaluated a group of 15 patients affected by major depressive disorder and complaining of insomnia, who started vortioxetine (VOR) treatment for their depressive symptoms. The following questionnaires were captured at baseline and follow-up: Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale and Beck Depression Inventory. Pittsburgh Sleep Quality Index total score significantly decreased between follow-up and baseline (P < 0.01), and in several subitems related to sleep quality and continuity. Moreover, Epworth Sleepiness Scale decreased between follow-up and baseline (P < 0.01). Finally, Beck Depression Inventory reduction was also evident between follow-up and baseline (P < 0.01). This retrospective analysis showing the significant effect of VOR on both depressive symptoms and insomnia in patients showing comorbid major depressive disorder and insomnia invites further research in order to confirm this preliminary evidence. We hypothesize that the VOR mechanism of action may explain the improvement of subjective sleep, other than depressive symptoms.

Topics: Adult; Antidepressive Agents; Depressive Disorder, Major; Female; Follow-Up Studies; Humans; Male; Middle Aged; Psychiatric Status Rating Scales; Retrospective Studies; Severity of Illness Index; Sleep; Sleep Initiation and Maintenance Disorders; Surveys and Questionnaires; Vortioxetine