title: Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day-A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia.
abstract: Paliperidone extended-release (paliperidone ER) is an approved oral antipsychotic medication (dosing range 3-12 mg/day) for treatment of schizophrenia and schizoaffective disorder in adults.
  In this 3-arm, double-blind, placebo- and active-controlled, parallel-group study, paliperidone ER 1.5 mg was assessed to determine the lowest efficacious dose in patients (N = 201) with acute schizophrenia. Paliperidone ER 6 mg was included for assay sensitivity.
  Patients (intent-to-treat analysis set) had a mean age of 39.4 years; 74% were men, 43% Asian, and 40% black. The baseline mean (SD) Positive and Negative Syndrome Scale (PANSS) total score was 92.6 (13.02) and the mean (SD) change from baseline to endpoint was: placebo group, -11.4 (20.81); paliperidone ER 1.5 mg group, -8.9 (23.31); and paliperidone ER 6 mg group, -15.7 (26.25). Differences between paliperidone groups versus placebo were not significant (paliperidone ER 1.5 mg [p = 0.582], paliperidone ER 6 mg, [p = 0.308]). Safety results of paliperidone ER 1.5 mg and placebo were comparable. The most frequently reported treatment emergent adverse events (≥10%) were: placebo group-headache (15.6%) and psychotic disorder (14.1%); paliperidone ER 1.5 mg group-insomnia (13.6%); and paliperidone ER 6 mg group-headache (11.4%), insomnia (10%), and tremor (10%).
  In this study, paliperidone ER 1.5 mg did not demonstrate efficacy in patients with acute schizophrenia. A markedly high placebo response was noted. Assay sensitivity with the 6 mg dose was not established. Paliperidone ER 1.5 mg was generally tolerable with a safety profile comparable to placebo.
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: Danielle
authors.initials: D
authors.lastname: Coppola
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: Rama
authors.initials: R
authors.lastname: Melkote
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: Caroline
authors.initials: C
authors.lastname: Lannie
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: Jaskaran
authors.initials: J
authors.lastname: Singh
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: Isaac
authors.initials: I
authors.lastname: Nuamah
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: Srihari
authors.initials: S
authors.lastname: Gopal
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: David
authors.initials: D
authors.lastname: Hough
authors.affiliation: Dr. Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms. Melkote, MSc, MPH, Manager, Biostatistics, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.; Ms. Lannie, M.Sc., Scientist Clin Pharm, Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, NV, Beerse, Belgium; Drs. Singh, MD, Director, Neuroscience Therapeutic Area, Nuamah, PhD, Associate Director, Biostatistics, Gopal, MD, Senior Director Clinical Leader, Neuroscience Therapeutic Area, Hough, MD, Interim Manager Psychiatry Franchise, Neuroscience Therapeutic Area, Palumbo, MD, Head, Psychiatry Clinical Research and Development, and Franchise Medical Leader for Psychiatry within the Neuroscience Therapeutic Area, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, U.S.A.
authors.forename: Joseph
authors.initials: J
authors.lastname: Palumbo
keywords: Antipsychotic; extended-release; lowest effective dose; paliperidone; schizophrenia