Srihari Gopal

Summary

Publications

  1. ncbi request reprint Symptomatic remission in patients with bipolar mania: results from a double-blind, placebo-controlled trial of risperidone monotherapy
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, USA
    J Clin Psychiatry 66:1016-20. 2005
  2. pmc A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia
    Danielle Coppola
    Janssen Research and Development, LLC, Raritan, New Jersey, USA
    BMC Psychiatry 12:26. 2012
  3. doi request reprint Risk of cardiovascular morbidity with risperidone or paliperidone treatment: analysis of 64 randomized, double-blind trials
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, NJ, USA
    J Clin Psychopharmacol 33:157-61. 2013
  4. doi request reprint A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia
    Gahan Pandina
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey 08560, USA
    Prog Neuropsychopharmacol Biol Psychiatry 35:218-26. 2011
  5. doi request reprint Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial
    Joris Berwaerts
    Janssen Research and Development, LLC, Titusville, New Jersey
    JAMA Psychiatry 72:830-9. 2015
  6. pmc A Post-hoc comparison of paliperidone palmitate to oral risperidone during initiation of long-acting risperidone injection in patients with acute schizophrenia
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey, USA
    Innov Clin Neurosci 8:26-33. 2011
  7. doi request reprint Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey 08560, USA
    Int Clin Psychopharmacol 25:247-56. 2010
  8. doi request reprint Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data
    Mahesh N Samtani
    Johnson Johnson Pharmaceutical Research Development, L L C, Raritan, NJ, USA
    CNS Drugs 25:829-45. 2011
  9. pmc Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies
    Michael Markowitz
    Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road, Titusville, NJ 08560, USA
    Ann Gen Psychiatry 12:22. 2013
  10. pmc 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
    Danielle Coppola
    Dr Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms Melkote, MSc, MPH, Manager, Biostatistics, Johnson and Johnson Pharmaceutical Research and Development, L L C, Raritan, New Jersey, U S A Ms Lannie, M Sc, Scientist Clin Pharm, Johnson and Johnson Pharmaceutical Research and 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, Department of Paediatrics
    Psychopharmacol Bull 44:54-72. 2011

Collaborators

Detail Information

Publications24

  1. ncbi request reprint Symptomatic remission in patients with bipolar mania: results from a double-blind, placebo-controlled trial of risperidone monotherapy
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, USA
    J Clin Psychiatry 66:1016-20. 2005
    ..The purpose of this analysis was to assess rates of symptomatic remission in patients with bipolar mania receiving risperidone in a double-blind, parallel-group, multicenter, placebo-controlled trial conducted in India...
  2. pmc A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia
    Danielle Coppola
    Janssen Research and Development, LLC, Raritan, New Jersey, USA
    BMC Psychiatry 12:26. 2012
    ..This study evaluates safety and tolerability, as well as pharmacokinetics, of the highest marketed dose of PP (150 mg eq. [234 mg]) in stable patients with schizophrenia over a 1-year period...
  3. doi request reprint Risk of cardiovascular morbidity with risperidone or paliperidone treatment: analysis of 64 randomized, double-blind trials
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, NJ, USA
    J Clin Psychopharmacol 33:157-61. 2013
    ..Apart from events described in existing product labeling, no new safety findings emerged...
  4. doi request reprint A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia
    Gahan Pandina
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey 08560, USA
    Prog Neuropsychopharmacol Biol Psychiatry 35:218-26. 2011
    ..4 [-1.62;2.38], per-protocol analysis set [primary analysis]). The tolerability and safety of PP was generally similar to RIS-LAI with no new safety or tolerability findings...
  5. doi request reprint Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial
    Joris Berwaerts
    Janssen Research and Development, LLC, Titusville, New Jersey
    JAMA Psychiatry 72:830-9. 2015
    ..The long-acting 3-month formulation of paliperidone palmitate, owing to its extended elimination half-life, may offer a valuable therapeutic option for these patients...
  6. pmc A Post-hoc comparison of paliperidone palmitate to oral risperidone during initiation of long-acting risperidone injection in patients with acute schizophrenia
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey, USA
    Innov Clin Neurosci 8:26-33. 2011
    ..First-month data of a 13-week acute schizophrenia study were used to compare paliperidone palmitate to oral risperidone during initiation of long-acting injectable risperidone...
  7. doi request reprint Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey 08560, USA
    Int Clin Psychopharmacol 25:247-56. 2010
    ..than placebo (>or=5% difference) were headache, vomiting, extremity pain, and injection site pain. Treatment with paliperidone palmitate (100 mg eq.) was efficacious and all doses tested were tolerable...
  8. doi request reprint Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data
    Mahesh N Samtani
    Johnson Johnson Pharmaceutical Research Development, L L C, Raritan, NJ, USA
    CNS Drugs 25:829-45. 2011
    ..Population PK modelling presented in this review has helped provide practical guidance for administering this novel LAI antipsychotic...
  9. pmc Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies
    Michael Markowitz
    Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road, Titusville, NJ 08560, USA
    Ann Gen Psychiatry 12:22. 2013
    ..Increasing availability and use of long-acting injectable antipsychotics have generated a need to compare these formulations with their oral equivalents; however, a paucity of relevant data is available...
  10. pmc 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
    Danielle Coppola
    Dr Coppola, MD, Director, Neuroscience Therapeutic Area and, Ms Melkote, MSc, MPH, Manager, Biostatistics, Johnson and Johnson Pharmaceutical Research and Development, L L C, Raritan, New Jersey, U S A Ms Lannie, M Sc, Scientist Clin Pharm, Johnson and Johnson Pharmaceutical Research and 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, Department of Paediatrics
    Psychopharmacol Bull 44:54-72. 2011
    ..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...
  11. doi request reprint Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia
    Srihari Gopal
    a a Janssen Research and Development LLC, Raritan, NJ, USA
    Curr Med Res Opin 31:2043-54. 2015
    ..This commentary summarizes recommended dosing strategies for a recently developed 3 monthly long-acting injectable 1 (LAI) formulation of paliperidone palmitate (PP3M) for the treatment of schizophrenia in adults...
  12. doi request reprint Long-Term Safety of Paliperidone Extended Release in Adolescents with Schizophrenia: An Open-Label, Flexible Dose Study
    Adam Savitz
    Janssen Research and Development, LLC, Titusville, New Jersey
    J Child Adolesc Psychopharmacol 25:548-57. 2015
    ..The purpose of this study was to evaluate the long-term safety and tolerability of paliperidone extended-release (ER) in adolescents with schizophrenia...
  13. doi request reprint Factors associated with relapse in schizophrenia despite adherence to long-acting injectable antipsychotic therapy
    Larry Alphs
    aJanssen Scientific Affairs bJanssen Research and Development, LLC, Titusville, New Jersey cSaint Louis University School of Medicine, St Louis, Missouri, USA
    Int Clin Psychopharmacol 31:202-9. 2016
    ..0181). Findings suggest that patients with more chronic illness have a greater risk of relapse despite ensured treatment adherence, supporting the need for early intervention to prevent the deleterious effects of chronicity. ..
  14. pmc Expansion of guidance for the day 8 initiation dose of paliperidone palmitate to avoid a missed dose
    Mahesh N Samtani
    Janssen Research and Development, LLC, NJ, USA
    Neuropsychiatr Dis Treat 9:721-30. 2013
    ..Recently, expansion of the day 8 dosing window from ±2 to ±4 days has been approved in the United States based on results obtained from the model-based simulations and review of safety data presented here...
  15. pmc Are the long-acting intramuscular formulations of risperidone or paliperidone palmitate associated with post-injection delirium/sedation syndrome? An assessment of safety databases
    Larry Alphs
    Ortho McNeil Janssen Scientific Affairs, 1125 Trenton Harbourton Road, Titusville, NJ 08560, USA
    Curr Drug Saf 6:43-5. 2011
    ..Examination of these prospective databases finds no evidence that risperidone LAI and paliperidone palmitate are associated with PDSS and suggest that findings seen with another antipsychotic LAI are not generalizable...
  16. doi request reprint A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia
    Gahan J Pandina
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, NJ 08560, USA
    J Clin Psychopharmacol 30:235-44. 2010
    ..6% vs 0.0%), and myalgia (1.0% vs 0.0%). The paliperidone palmitate treatment was efficacious and generally tolerated across the dose range (25, 100, or 150 mg eq.) in adult patients with acutely exacerbated schizophrenia...
  17. pmc Number needed to treat and number needed to harm with paliperidone palmitate relative to long-acting haloperidol, bromperidol, and fluphenazine decanoate for treatment of patients with schizophrenia
    Srihari Gopal
    Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, NJ, USA
    Neuropsychiatr Dis Treat 7:93-101. 2011
    ....
  18. pmc Genome-wide association study of paliperidone efficacy
    Qingqin Li
    aNeuroscience, Janssen Research and Development, LLC bJanssen Scientific Affairs, LLC, Titusville cJanssen Research and Development, LLC, Raritan dBlue Note Biosciences, LLC, Princeton, New Jersey eBiostatistics and Bioinformatics, The Scripps Translational Science Institute fDepartment of Molecular and Experimental Medicine, The Scripps Research Institute gScripps Health hHuman Biology, J Craig Venter Institute, La Jolla iMD Revolution, San Diego, California, USA
    Pharmacogenet Genomics 27:7-18. 2017
    ..Clinical response to the atypical antipsychotic paliperidone is known to vary among schizophrenic patients. We carried out a genome-wide association study to identify common genetic variants predictive of paliperidone efficacy...
  19. doi request reprint Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study
    ADAM J SAVITZ
    Janssen Research and Development, LLC, Titusville, NJ Electronic address
    J Am Acad Child Adolesc Psychiatry 54:126-137.e1. 2015
    ..To evaluate the efficacy, safety, and tolerability of paliperidone extended release (ER) relative to aripiprazole in adolescent schizophrenia...
  20. doi request reprint Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study
    David Hough
    Johnson and Johnson Pharmaceutical Research and Development, L L C, Raritan, New Jersey, USA
    Schizophr Res 116:107-17. 2010
    ..We assessed efficacy and tolerability of the injectable atypical antipsychotic paliperidone palmitate in delaying time-to-relapse in adults with schizophrenia...
  21. pmc Benefit-risk assessment of paliperidone oral extended-release tablet versus monthly injectable for maintenance treatment of schizophrenia
    Bennett Levitan
    aJanssen Research and Development, LLC bJanssen Scientific Affairs, LLC, Titusville, New Jersey, USA
    Int Clin Psychopharmacol 31:315-22. 2016
    ..These analyses suggest a benefit-risk profile favoring PP1M over oral paliperidone ER throughout 40 weeks of treatment, particularly in early treatment. ..
  22. doi request reprint Large-scale candidate gene study to identify genetic risk factors predictive of paliperidone treatment response in patients with schizophrenia
    Dai Wang
    aJanssen Research and Development, LLC, Raritan bJanssen Scientific Affairs, LLC, Titusville, New Jersey cJanssen Research and Development, LLC, Titusville, New Jersey, USA
    Pharmacogenet Genomics 25:173-85. 2015
    ..To this end, we carried out a large-scale candidate gene study to identify genetic risk factors predictive of paliperidone efficacy...
  23. doi request reprint Personal and social functioning in schizophrenia: defining a clinically meaningful measure of maintenance in relapse prevention
    Deborah Nicholl
    Johnson and Johnson Pharmaceutical Services, LLC, Raritan, NJ 08869, USA
    Curr Med Res Opin 26:1471-84. 2010
    ....
  24. doi request reprint Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia
    David Hough
    Johnson and Johnson Pharmaceutical Research and Development, L L C, Raritan, NJ, USA
    Prog Neuropsychopharmacol Biol Psychiatry 33:1022-31. 2009
    ..Paliperidone palmitate treatment was tolerated, irrespective of injection site, and thus could offer the choice of administration into either the deltoid or gluteal muscle to meet patient and physician preference...