Evaluation of the efficacy and safety of paliperidone extended-release in the treatment of acute mania: a randomized, double-blind, dose-response study

Journal of Affective Disorders
Joris BerwaertsDavid W Hough

Abstract

Atypical antipsychotics are effective in the treatment of bipolar I disorder. In this 3-week double-blind study, the efficacy and safety of paliperidone extended-release (ER) tablets were assessed in patients with acute mania. Patients experiencing a manic or mixed episode (Young Mania Rating Scale [YMRS] total score ≥20), were randomly assigned to 1 of 3 fixed doses of once-daily paliperidone ER (3, 6, or 12-mg), or placebo (1:1:1:1 ratio). In total, 469 patients were randomly assigned to treatment with paliperidone ER 3mg (n=112), 6 mg (n=120), or 12 mg (n=115); or placebo (n=122). Mean (SD) change in YMRS total score from baseline to the 3-week endpoint (primary variable) was statistically significantly different for the paliperidone ER 12 mg group (-13.5 [9.17], p=0.025), but not the 6 mg (-11.4 [9.98], p=0.57) or 3mg (-9.1 [11.18], p=0.79) groups compared with placebo (-10.1 [10.21]). Headache was the most common treatment-emergent adverse event (17% total paliperidone ER versus 12% placebo). A statistically significant (p=0.0032) treatment-by-country interaction occurred, which confounded interpretation of study results. Paliperidone ER and placebo did not differ statistically for the primary efficacy variable among patie...Continue Reading

References

Apr 1, 1979·The British Journal of Psychiatry : the Journal of Mental Science·S A Montgomery, M Asberg
Apr 1, 1979·Journal of Consulting and Clinical Psychology·A T BeckA Weissman
Nov 1, 1978·The British Journal of Psychiatry : the Journal of Mental Science·R C YoungD A Meyer
May 1, 1989·The British Journal of Psychiatry : the Journal of Mental Science·T R Barnes
Jan 1, 1987·Schizophrenia Bulletin·S R KayL A Opler
Jan 1, 1970·Acta Psychiatrica Scandinavica. Supplementum·G M Simpson, J W Angus
Jul 24, 1996·JAMA : the Journal of the American Medical Association·M M WeissmanE K Yeh
Feb 1, 1996·Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology·C M BeasleyS Hamilton
Feb 4, 2003·The British Journal of Psychiatry : the Journal of Mental Science·Laksami N YathamArun Ravindran
Mar 12, 2003·Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology·Arif KhanEarl L Giller
Sep 2, 2005·The British Journal of Psychiatry : the Journal of Mental Science·Sumant KhannaMichelle Kramer
Sep 30, 2005·The International Journal of Neuropsychopharmacology·Martin LetmaierSiegfried Kasper
May 4, 2006·The Journal of Clinical Psychiatry·Roy H PerlisPaul E Keck
Mar 27, 2007·Journal of Affective Disorders·Eduard VietaBjörn Paulsson
Aug 21, 2007·BMC Psychiatry·Sheena Derry, R Andrew Moore
Jan 9, 2008·BMC Psychiatry·Ilya LipkovichJohn P Houston
Dec 25, 2008·Schizophrenia Research·Leslie CitromeKafi N Sanders

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Citations

May 25, 2012·European Archives of Psychiatry and Clinical Neuroscience·Konstantinos N FountoulakisEduard Vieta
Mar 31, 2011·Drug Design, Development and Therapy·Maximilian GahrRoland W Freudenmann
May 10, 2012·Neuropsychiatric Disease and Treatment·Jehan MarinoCatherine Harrington
Nov 18, 2014·Expert Opinion on Drug Safety·Richard MusilMichael Hamerle
Nov 6, 2015·Case Reports in Psychiatry·Kadir DemirciCafer Çağrı Korucu
May 16, 2014·The World Journal of Biological Psychiatry : the Official Journal of the World Federation of Societies of Biological Psychiatry·Heinz Grunze, Jean Michel Azorin
Jan 6, 2012·The International Journal of Neuropsychopharmacology·Konstantinos N FountoulakisLakshmi N Yatham
May 6, 2015·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Isabella PacchiarottiEduard Vieta
Dec 23, 2016·Expert Review of Neurotherapeutics·Fang FangKeming Gao
Apr 19, 2017·CNS Spectrums·Alessandro CuomoAllan H Young
Aug 13, 2013·Journal of the Chinese Medical Association : JCMA·Ya-Mei BaiTung-Ping Su
Jul 27, 2017·The Journal of Pharmacy and Pharmacology·Akash Patil, Soumyajit Majumdar
Sep 16, 2015·CNS Drugs·Andrea FagioliniAllan H Young
Nov 4, 2017·The World Journal of Biological Psychiatry : the Official Journal of the World Federation of Societies of Biological Psychiatry·Heinz GrunzeUNKNOWN Members of the WFSBP Task Force on Bipolar Affective Disorders Working on this topic

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