PMID- 27536449
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160818
LR  - 20200930
IS  - 2155-6660 (Print)
IS  - 2155-6660 (Electronic)
IS  - 2155-6660 (Linking)
VI  - 3
IP  - 1
DP  - 2014
TI  - A randomized, double-blind, placebo-controlled study of flexible doses of 
      levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder.
PG  - 10-9
LID - 10.3109/21556660.2014.884505 [doi]
AB  - OBJECTIVE: Levomilnacipran ER is a potent and selective serotonin and 
      norepinephrine reuptake inhibitor (SNRI) approved for the treatment of major 
      depressive disorder (MDD). Efficacy and safety have been evaluated in five Phase 
      II/III studies, four of which met the pre-specified primary efficacy outcome. 
      Results of the negative trial (ClinicalTrials.gov NCT00969150) are reported here. 
      METHODS: A Phase III randomized, double-blind, placebo-controlled trial comparing 
      flexible-dose levomilnacipran ER 40-120 mg/day with placebo was conducted in 
      outpatients with MDD. Patients met the DSM-IV-TR criteria for MDD, had a current 
      episode of depression of at least 4 weeks' duration, and a Montgomery-Asberg 
      Depression Rating Scale (MADRS) total score >/=30. The study comprised a 1-week, 
      single-blind, placebo lead-in, 8-week double-blind treatment, and a 2-week 
      down-taper. The primary and secondary efficacy measures were change from baseline 
      to Week 8 in MADRS and Sheehan Disability Scale (SDS) total scores, respectively, 
      analyzed using a mixed-effects model for repeated measures approach. Safety 
      outcomes included adverse events (AEs), laboratory and vital sign measures, the 
      Columbia-Suicide Severity Rating Scale, and the Arizona Sexual Experiences Scale 
      (ASEX). RESULTS: Three hundred and fifty-five patients received the study drug 
      and had >/=1 post-baseline MADRS total score assessment (ITT Population); 81.9% of 
      placebo and 77.1% of levomilnacipran ER patients completed the study. For 
      levomilnacipran ER vs placebo, MADRS (-15.7 vs -14.2) and SDS (-8.8 vs -8.2) 
      total score improvements, and rates of MADRS response (38.5% vs 34.8%) and 
      remission (25.3% vs 23.8%) were numerically greater but differences were not 
      statistically significant. Levomilnacipran ER was generally well tolerated. More 
      levomilnacipran ER patients vs placebo reported AEs; the most common AEs for 
      levomilnacipran ER were nausea (17%) and headache (16%). Mean changes in most 
      safety measures were small and similar between groups. There were no meaningful 
      differences in total ASEX scores between groups. LIMITATIONS: Short duration of 
      treatment, inclusion and exclusion criteria, and lack of an active comparator. 
      CONCLUSION: Numerical improvements for levomilnacipran ER vs placebo were 
      detected in this study, but the differences were not statistically significant; 
      levomilnacipran ER was generally well tolerated.
FAU - Gommoll, Carl P
AU  - Gommoll CP
AD  - Forest Research Institute, Jersey City, NJUSA.
FAU - Greenberg, William M
AU  - Greenberg WM
AD  - Forest Research Institute, Jersey City, NJUSA.
FAU - Chen, Changzheng
AU  - Chen C
AD  - Forest Research Institute, Jersey City, NJUSA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00969150
PT  - Journal Article
DEP - 20140116
PL  - England
TA  - J Drug Assess
JT  - Journal of drug assessment
JID - 101672979
PMC - PMC4937636
OTO - NOTNLM
OT  - Antidepressant clinical trial
OT  - Levomilnacipran ER
OT  - Major depressive disorder (MDD)
OT  - Serotonin and norepinephrine reuptake inhibitor (SNRI)
EDAT- 2014/01/01 00:00
MHDA- 2014/01/01 00:01
PMCR- 2014/01/01
CRDT- 2016/08/19 06:00
PHST- 2014/01/09 00:00 [accepted]
PHST- 2016/08/19 06:00 [entrez]
PHST- 2014/01/01 00:00 [pubmed]
PHST- 2014/01/01 00:01 [medline]
PHST- 2014/01/01 00:00 [pmc-release]
AID - ijda-3-10 [pii]
AID - 10.3109/21556660.2014.884505 [doi]
PST - epublish
SO  - J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. 
      eCollection 2014.