PMID- 17601495
OWN - NLM
STAT- MEDLINE
DCOM- 20080227
LR  - 20220408
IS  - 1873-2402 (Electronic)
IS  - 0006-3223 (Linking)
VI  - 62
IP  - 12
DP  - 2007 Dec 15
TI  - Efficacy and safety of paliperidone extended-release tablets: results of a 
      6-week, randomized, placebo-controlled study.
PG  - 1363-70
AB  - BACKGROUND: Paliperidone extended-release tablet (paliperidone ER; Invega, 
      Janssen L.P., Titusville, New Jersey) is an oral psychotropic for schizophrenia 
      treatment. METHODS: Efficacy and safety of once-daily paliperidone ER (6 and 12 
      mg) were assessed versus placebo in 444 patients with acute schizophrenia in a 
      6-week, multicenter, double-blind, randomized, parallel-group study. An 
      olanzapine (10 mg) treatment arm was included to confirm trial validity. RESULTS: 
      Both doses of paliperidone ER demonstrated significant improvement in Positive 
      and Negative Syndrome Scale (PANSS) total score (p < or = .006) and certain PANSS 
      Marder factor scores compared with placebo (p < or = .025); PANSS total score 
      also improved in the olanzapine treatment arm. Paliperidone ER 6 mg (p < or = 
      .008), but not 12 mg, was associated with significant improvements in personal 
      and social performance. The incidence of treatment-emergent adverse events (AEs) 
      for paliperidone ER 6 mg was comparable with placebo and slightly greater with 
      paliperidone ER 12 mg. Changes in blood glucose and lipid levels with 
      paliperidone ER were comparable with placebo. Two patients treated with 
      paliperidone ER experienced glucose-related AEs. Body-weight increases of 1-2 kg 
      were observed with paliperidone ER. Although there were increases in plasma 
      prolactin levels with paliperidone ER treatment, the incidence of 
      prolactin-related AEs was < or =1%. CONCLUSIONS: In this study, paliperidone ER, 
      particularly the 6-mg dose, was effective and well tolerated, and provides a 
      valuable new treatment option for schizophrenia.
FAU - Marder, Stephen R
AU  - Marder SR
AD  - Veteran's Affairs Veteran's Integrated Service Networks 22 Mental Illness 
      Research, Education, and Clinical Center, Los Angeles, California 90073, USA. 
      marder@ucla.edu
FAU - Kramer, Michelle
AU  - Kramer M
FAU - Ford, Lisa
AU  - Ford L
FAU - Eerdekens, Els
AU  - Eerdekens E
FAU - Lim, Pilar
AU  - Lim P
FAU - Eerdekens, Marielle
AU  - Eerdekens M
FAU - Lowy, Adam
AU  - Lowy A
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070628
PL  - United States
TA  - Biol Psychiatry
JT  - Biological psychiatry
JID - 0213264
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Blood Glucose)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Isoxazoles)
RN  - 0 (Pyrimidines)
RN  - R8P8USM8FR (Paliperidone Palmitate)
SB  - IM
MH  - Adult
MH  - Analysis of Variance
MH  - Antipsychotic Agents/*administration & dosage/adverse effects
MH  - Blood Glucose/drug effects
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - *Drug Evaluation
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Isoxazoles/*administration & dosage/adverse effects
MH  - Lipid Metabolism/drug effects
MH  - Male
MH  - Middle Aged
MH  - Paliperidone Palmitate
MH  - Psychiatric Status Rating Scales
MH  - Pyrimidines/*administration & dosage/adverse effects
MH  - Schizophrenia/*drug therapy
MH  - Treatment Outcome
EDAT- 2007/07/03 09:00
MHDA- 2008/02/28 09:00
CRDT- 2007/07/03 09:00
PHST- 2006/10/02 00:00 [received]
PHST- 2007/01/10 00:00 [revised]
PHST- 2007/01/29 00:00 [accepted]
PHST- 2007/07/03 09:00 [pubmed]
PHST- 2008/02/28 09:00 [medline]
PHST- 2007/07/03 09:00 [entrez]
AID - S0006-3223(07)00143-6 [pii]
AID - 10.1016/j.biopsych.2007.01.017 [doi]
PST - ppublish
SO  - Biol Psychiatry. 2007 Dec 15;62(12):1363-70. doi: 10.1016/j.biopsych.2007.01.017. 
      Epub 2007 Jun 28.