PMID- 30675739
OWN - NLM
STAT- MEDLINE
DCOM- 20190805
LR  - 20210109
IS  - 1520-6394 (Electronic)
IS  - 1091-4269 (Print)
IS  - 1091-4269 (Linking)
VI  - 36
IP  - 3
DP  - 2019 Mar
TI  - Relapse prevention with levomilnacipran ER in adults with major depressive 
      disorder: A multicenter, randomized, double-blind, placebo-controlled study.
PG  - 225-234
LID - 10.1002/da.22872 [doi]
AB  - BACKGROUND: Levomilnacipran extended release (ER) is a serotonin and 
      norepinephrine reuptake inhibitor approved for major depressive disorder (MDD) in 
      adults. This study was designed to evaluate relapse prevention with 
      levomilnacipran ER in patients with MDD. METHODS: Patients (>/=18 years) with MDD 
      (N = 644) received 20 weeks of open-label treatment with levomilnacipran ER 40, 
      80, or 120 mg/d (8 weeks flexible dosing; 12 weeks fixed dosing). Patients with a 
      Montgomery-Asberg Depression Rating Scale (MADRS) total score </=12 from the end of 
      week 8 to week 20 were randomized to 26 weeks of double-blind treatment with 
      levomilnacipran ER (same dosage; n = 165) or placebo (n = 159). The primary 
      efficacy endpoint was time to relapse, defined as insufficient therapeutic 
      response (>/=2-point increase from randomization in Clinical Global Impression of 
      Severity score, risk of suicide, need for hospitalization due to worsening of 
      depression, or need for alternative antidepressant treatment as determined by the 
      investigator) or an MADRS total score >/=18 at 2 consecutive visits. RESULTS: In 
      the double-blind intent-to-treat population, levomilnacipran ER-treated patients 
      had a significantly longer time to relapse compared with placebo (hazard 
      ratio = 0.56; 95% CI, 0.33-0.92; P = 0.0212). Crude relapse rates were 14.5% 
      (levomilnacipran ER) and 24.5% (placebo). Double-blind treatment-emergent adverse 
      events (AEs) were reported for 58.8% and 56.0% of levomilnacipran ER and placebo 
      patients, respectively; 3.0% and 1.3% discontinued due to AEs, and 1.2% and 0.6% 
      had serious AEs, respectively. CONCLUSION: Levomilnacipran ER (40-120 mg/d) was 
      effective in preventing relapse in patients with MDD. Safety and tolerability 
      results were consistent with levomilnacipran ER acute studies.
CI  - (c) 2019 The Authors. Depression and Anxiety published by Wiley Periodicals, Inc.
FAU - Durgam, Suresh
AU  - Durgam S
AUID- ORCID: 0000-0001-6629-0619
AD  - Allergan, Madison, New Jersey.
FAU - Chen, Changzheng
AU  - Chen C
AD  - Allergan, Madison, New Jersey.
FAU - Migliore, Raffaele
AU  - Migliore R
AD  - Allergan, Madison, New Jersey.
FAU - Prakash, Chandran
AU  - Prakash C
AD  - Allergan, Madison, New Jersey.
FAU - Thase, Michael E
AU  - Thase ME
AD  - University of Pennsylvania Health System, Philadelphia, Pennsylvania.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190123
PL  - United States
TA  - Depress Anxiety
JT  - Depression and anxiety
JID - 9708816
RN  - 0 (Antidepressive Agents)
RN  - 0 (Serotonin and Noradrenaline Reuptake Inhibitors)
RN  - UGM0326TXX (Levomilnacipran)
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/*therapeutic use
MH  - Depressive Disorder, Major/*prevention & control/psychology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Levomilnacipran/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Recurrence
MH  - Secondary Prevention
MH  - Serotonin and Noradrenaline Reuptake Inhibitors/*therapeutic use
MH  - Suicide/psychology
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC6590342
OTO - NOTNLM
OT  - antidepressant
OT  - depression
OT  - levomilnacipran extended release
OT  - long-term treatment
OT  - maintenance treatment
OT  - randomized withdrawal
EDAT- 2019/01/25 06:00
MHDA- 2019/08/06 06:00
PMCR- 2019/06/24
CRDT- 2019/01/25 06:00
PHST- 2017/12/19 00:00 [received]
PHST- 2018/09/27 00:00 [revised]
PHST- 2018/11/30 00:00 [accepted]
PHST- 2019/01/25 06:00 [pubmed]
PHST- 2019/08/06 06:00 [medline]
PHST- 2019/01/25 06:00 [entrez]
PHST- 2019/06/24 00:00 [pmc-release]
AID - DA22872 [pii]
AID - 10.1002/da.22872 [doi]
PST - ppublish
SO  - Depress Anxiety. 2019 Mar;36(3):225-234. doi: 10.1002/da.22872. Epub 2019 Jan 23.