PMID- 25575488
OWN - NLM
STAT- MEDLINE
DCOM- 20151204
LR  - 20221207
IS  - 1432-2072 (Electronic)
IS  - 0033-3158 (Print)
IS  - 0033-3158 (Linking)
VI  - 232
IP  - 12
DP  - 2015 Jun
TI  - A randomized, double-blind, duloxetine-referenced study comparing efficacy and 
      tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults 
      with MDD.
PG  - 2061-70
LID - 10.1007/s00213-014-3839-0 [doi]
AB  - RATIONALE: Vortioxetine has reduced depressive symptoms in adults with major 
      depressive disorder (MDD) in multiple clinical trials. OBJECTIVES: 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. METHODS: 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-Asberg 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. RESULTS: 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. CONCLUSIONS: Vortioxetine 20 mg significantly reduced MADRS total 
      scores after 8 weeks of treatment. Both vortioxetine doses were well tolerated. 
      CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01153009; 
      www.clinicaltrials.gov/ .
FAU - Mahableshwarkar, Atul R
AU  - Mahableshwarkar AR
AD  - CNS Medicine, Clinical Science, CNS Statistics, Pharmacovigilance, Takeda 
      Development Center Americas, 1 Takeda Parkway, Deerfield, IL, 60015, USA, 
      atul.mahableshwarkar@takeda.com.
FAU - Jacobsen, Paula L
AU  - Jacobsen PL
FAU - Chen, Yinzhong
AU  - Chen Y
FAU - Serenko, Michael
AU  - Serenko M
FAU - Trivedi, Madhukar H
AU  - Trivedi MH
LA  - eng
SI  - ClinicalTrials.gov/NCT01153009
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20150111
PL  - Germany
TA  - Psychopharmacology (Berl)
JT  - Psychopharmacology
JID - 7608025
RN  - 0 (Antidepressive Agents)
RN  - 0 (Piperazines)
RN  - 0 (Serotonin Uptake Inhibitors)
RN  - 0 (Sulfides)
RN  - 3O2K1S3WQV (Vortioxetine)
RN  - 9044SC542W (Duloxetine Hydrochloride)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/adverse effects/*therapeutic use
MH  - Depressive Disorder, Major/*drug therapy/psychology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Duloxetine Hydrochloride/adverse effects/*therapeutic use
MH  - Electrocardiography/drug effects
MH  - Fatigue/complications/psychology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Selective Serotonin Reuptake Inhibitors/adverse effects/*therapeutic use
MH  - Sleep Initiation and Maintenance Disorders/complications/psychology
MH  - Suicidal Ideation
MH  - Sulfides/adverse effects/*therapeutic use
MH  - Vortioxetine
MH  - Young Adult
PMC - PMC4432084
EDAT- 2015/01/13 06:00
MHDA- 2015/12/15 06:00
PMCR- 2015/01/11
CRDT- 2015/01/11 06:00
PHST- 2014/10/13 00:00 [received]
PHST- 2014/12/02 00:00 [accepted]
PHST- 2015/01/11 06:00 [entrez]
PHST- 2015/01/13 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
PHST- 2015/01/11 00:00 [pmc-release]
AID - 3839 [pii]
AID - 10.1007/s00213-014-3839-0 [doi]
PST - ppublish
SO  - Psychopharmacology (Berl). 2015 Jun;232(12):2061-70. doi: 
      10.1007/s00213-014-3839-0. Epub 2015 Jan 11.