PMID- 34513348
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210914
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 13
IP  - 7
DP  - 2021 Jul
TI  - A Phase III Prospective Active and Placebo-Controlled Randomized Trial of 
      Vilazodone in the Treatment of Major Depressive Disorder.
PG  - e16689
LID - 10.7759/cureus.16689 [doi]
LID - e16689
AB  - Background Depression is a leading cause of psychiatric morbidity in the modern 
      world, and the introduction of selective serotonin reuptake inhibitors (SSRIs) is 
      a revolution in the treatment of depression. Vilazodone, a novel SSRI and 5-HT1A 
      partial agonist, received FDA approval in 2011 to treat the major depressive 
      disorder (MDD) in adults. This study conducted in India aimed to evaluate the 
      efficacy and safety of vilazodone when compared to escitalopram or placebo in 
      patients with MDD. Methods This was a prospective, multicentre, randomized, 
      comparative study of 375 participants over eight weeks of treatment with either 
      vilazodone (10-40mg/day) or escitalopram (10-40 mg/day) or placebo in adult 
      patients with MDD. Primary efficacy was assessed using the Hamilton Rating Scale 
      for Depression (HAM-D-17); secondary efficacy was assessed using the 
      Montgomery-Asberg Depression Rating Scale (MADRS) score and Hamilton Anxiety 
      Scale (HAM-A) score. Safety parameters included adverse events (AEs), clinical 
      laboratory results, vital signs, electrocardiogram ( ECG), and Columbia-Suicide 
      Severity Rating Scale (C-SSRS). Results Mean change in the HAM-D-17 total score 
      from baseline to week 8 for vilazodone, escitalopram, and placebo-treated 
      patients in intent-to-treat (ITT) population was: -18.9 (+/- 7.49), -17.8 (+/- 6.06), 
      and -7.4 (+/- 6.32); in ITT population (with Last Observation Carried Forward( 
      LOCF) imputation) was: -17.9 (+/- 7.71), -17.4 (+/- 6.19), and -6.4 (+/- 6.84), and in 
      per-protocol (PP) population was: -19.1 (+/- 7.20), -17.8 (+/- 6.08), and -7.7 (+/- 
      6.29), respectively. The upper limit of 95% CI (0.56 (ITT); 0.90 (ITT with LOCF 
      Imputation); 0.23 (PP)) of difference in HAM-D-17 between vilazodone 40mg and 
      escitalopram 40mg, which is lower than the defined non-inferiority margin (3.56), 
      proving non-inferiority. The difference between vilazodone 40mg, escitalopram 
      40mg, and the placebo was statistically significant (p<0.0001). No deaths or 
      serious adverse events were reported in this study. Conclusion Vilazodone 
      demonstrated comparable efficacy to escitalopram and superior efficacy over the 
      placebo in the treatment of MDD.
CI  - Copyright (c) 2021, Sinha et al.
FAU - Sinha, Shubhadeep
AU  - Sinha S
AD  - Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.
FAU - Chary, Sreenivasa
AU  - Chary S
AD  - Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.
FAU - Thakur, Pankaj
AU  - Thakur P
AD  - Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.
FAU - Talluri, Leela
AU  - Talluri L
AD  - Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.
FAU - Reddy, Mohan
AU  - Reddy M
AD  - Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.
FAU - Verma, Kamal K
AU  - Verma KK
AD  - Psychiatry, Sardar Patel Medical College, Bikaner, IND.
FAU - Saha, Pradeep
AU  - Saha P
AD  - Psychiatry, Institute of Post-Graduate Medical Education and Research, Kolkata, 
      IND.
FAU - Gupta, Vijaya B
AU  - Gupta VB
AD  - Psychiatry, Rajiv Gandhi Institute of Medical Sciences, Srikakulam, IND.
FAU - Ramaiah, Kaja A
AU  - Ramaiah KA
AD  - Psychiatry, Sri Manasa Psychiatrist Hospital, Vijayawada, IND.
FAU - Khanum, Siquafa Z
AU  - Khanum SZ
AD  - Psychiatry, Nirmal Hospital, Jhansi, IND.
LA  - eng
PT  - Journal Article
DEP - 20210728
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
PMC - PMC8412205
OTO - NOTNLM
OT  - 5-ht1a partial agonist
OT  - antidepressant
OT  - major depressive disorder
OT  - selective serotonin reuptake inhibitor
OT  - vilazodone
COIS- The authors have declared that no competing interests exist.
EDAT- 2021/09/14 06:00
MHDA- 2021/09/14 06:01
PMCR- 2021/07/28
CRDT- 2021/09/13 06:52
PHST- 2021/07/28 00:00 [accepted]
PHST- 2021/09/13 06:52 [entrez]
PHST- 2021/09/14 06:00 [pubmed]
PHST- 2021/09/14 06:01 [medline]
PHST- 2021/07/28 00:00 [pmc-release]
AID - 10.7759/cureus.16689 [doi]
PST - epublish
SO  - Cureus. 2021 Jul 28;13(7):e16689. doi: 10.7759/cureus.16689. eCollection 2021 
      Jul.