PMID- 24772351
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140428
LR  - 20211021
IS  - 2090-2085 (Print)
IS  - 2090-2093 (Electronic)
IS  - 2090-2093 (Linking)
VI  - 2014
DP  - 2014
TI  - Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with 
      Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison.
PG  - 758212
LID - 10.1155/2014/758212 [doi]
LID - 758212
AB  - We tested the hypothesis that long-term treatment with pomaglumetad methionil 
      would demonstrate significantly less weight gain than aripiprazole in patients 
      with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 
      3 study, 678 schizophrenia patients were randomized to either pomaglumetad 
      methionil (n = 516) or aripiprazole (n = 162). Treatment groups were also 
      compared on efficacy and various safety measures, including serious adverse 
      events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent 
      adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related 
      thoughts and behaviors. The pomaglumetad methionil group showed significantly 
      greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group 
      (-2.8 +/- 0.4 versus 0.4 +/- 0.6; P < 0.001). However, change in Positive and 
      Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly 
      greater than for pomaglumetad methionil (-15.58 +/- 1.58 versus -12.03 +/- 0.99; P = 
      0.045). The incidences of SAEs (8.2% versus 3.1%; P = 0.032) and discontinuation 
      due to AEs (16.2% versus 8.7%; P = 0.020) were significantly higher for 
      pomaglumetad methionil compared with aripiprazole. No statistically significant 
      differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were 
      noted between treatment groups. In conclusion, long-term treatment with 
      pomaglumetad methionil resulted in significantly less weight gain than 
      aripiprazole. This trial is registered with ClinicalTrials.gov NCT01328093.
FAU - Adams, David H
AU  - Adams DH
AD  - Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, 
      Indianapolis, IN 46285, USA.
FAU - Zhang, Lu
AU  - Zhang L
AD  - Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, 
      Indianapolis, IN 46285, USA.
FAU - Millen, Brian A
AU  - Millen BA
AD  - Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, 
      Indianapolis, IN 46285, USA.
FAU - Kinon, Bruce J
AU  - Kinon BJ
AD  - Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, 
      Indianapolis, IN 46285, USA.
FAU - Gomez, Juan-Carlos
AU  - Gomez JC
AD  - Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, 
      Indianapolis, IN 46285, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01328093
PT  - Journal Article
DEP - 20140319
PL  - Egypt
TA  - Schizophr Res Treatment
JT  - Schizophrenia research and treatment
JID - 101576450
PMC - PMC3977437
EDAT- 2014/04/29 06:00
MHDA- 2014/04/29 06:01
PMCR- 2014/03/19
CRDT- 2014/04/29 06:00
PHST- 2013/10/16 00:00 [received]
PHST- 2014/01/31 00:00 [revised]
PHST- 2014/02/04 00:00 [accepted]
PHST- 2014/04/29 06:00 [entrez]
PHST- 2014/04/29 06:00 [pubmed]
PHST- 2014/04/29 06:01 [medline]
PHST- 2014/03/19 00:00 [pmc-release]
AID - 10.1155/2014/758212 [doi]
PST - ppublish
SO  - Schizophr Res Treatment. 2014;2014:758212. doi: 10.1155/2014/758212. Epub 2014 
      Mar 19.