Affiliation: Johnson and Johnson Pharmaceutical Research and Development
- Design and rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study: a novel comparative trial of once-monthly paliperidone palmitate versus daily oral antipsychotic treatment for delaying time to treatment failure in Larry Alphs
Therapeutic Team Leader Psychiatry, Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Rd A32404, Titusville, NJ 08560
J Clin Psychiatry 75:1388-93. 2014..We describe the design and rationale of a novel trial that combines both explanatory and pragmatic design features and studies persons with schizophrenia who face these challenges...
- How study designs influence comparative effectiveness outcomes: the case of oral versus long-acting injectable antipsychotic treatments for schizophreniaLarry Alphs
Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road, Titusville, NJ, USA Electronic address
Schizophr Res 156:228-32. 2014..This paper reviews the relative impact of these features when comparing LAI and oral antipsychotic treatments and makes recommendations for improving these comparative designs. ..
- Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychoticsLarry Alphs
CNS Medical Affairs, LLC, Titusville, NJ, USA
Neuropsychiatr Dis Treat 9:341-50. 2013....
- Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophreniaLarry Alphs
Therapeutic Area Leader Psychiatry, Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road A32404, Titusville, NJ 08560, USA 1 609 730 3693 1 609 730 3125
Expert Opin Pharmacother 15:1029-42. 2014..As patients with schizophrenia frequently present with diverse and challenging symptoms, it is important to understand the effects of antipsychotics in treating these different symptom subgroups and the timing of these responses...
- Limited utility of number needed to treat and the polarity index for bipolar disorder to characterize treatment responseLarry Alphs
Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road, Titusville, NJ 08560 2000, USA Electronic address
Eur Neuropsychopharmacol 23:1597-9. 2013..This commentary identifies some of the specific limitations of the NNT and PI constructs when applied to treatments of bipolar disorder. ..
- Placebo-related effects in clinical trials in schizophrenia: what is driving this phenomenon and what can be done to minimize it?Larry Alphs
Janssen Scientific Affairs, LLC, Titusville, NJ, USA
Int J Neuropsychopharmacol 15:1003-14. 2012..This is followed by a description of protocol/study design and study conduct issues that are contributing to a growing placebo effect in clinical trials. Potential solutions to these problems are provided...
- Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trialLarry Alphs
Ortho McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA
Ann Gen Psychiatry 10:12. 2011..abstract:..
- Are the long-acting intramuscular formulations of risperidone or paliperidone palmitate associated with post-injection delirium/sedation syndrome? An assessment of safety databasesLarry 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...
- Relationship between the clinical global impression of severity for schizoaffective disorder scale and established mood scales for mania and depressionIbrahim Turkoz
Janssen Research and Development, LLC, 1125 Trenton Harbourton Road, Titusville, NJ 08650, USA
J Affect Disord 150:17-22. 2013..This analysis explored the relationship between ratings on HAM-D-17 or YMRS and those on the depressive or manic subscale of CGI-S for schizoaffective disorder (CGI-S-SCA)...
- Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparisonDong Jing Fu
aMedical Affairs bMedical Information, Janssen Scientific Affairs, LLC cBiostatistics, B and P, Janssen Research and Development, LLC, Titusville, New Jersey, USA
Int Clin Psychopharmacol 29:45-55. 2014..In patients with recently diagnosed schizophrenia, the tolerability and efficacy of PP and RLAI were generally similar over 13 weeks...
- Adjunctive long-acting risperidone in patients with bipolar disorder who relapse frequently and have active mood symptomsWayne Macfadden
Janssen Scientific Affairs, LLC, Titusville, NJ, USA
BMC Psychiatry 11:171. 2011....
- Effects of acute paliperidone palmitate treatment in subjects with schizophrenia recently treated with oral risperidoneJennifer Kern Sliwa
Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road, Titusville, NJ, USA
Schizophr Res 132:28-34. 2011..To examine efficacy and safety of acute treatment with paliperidone palmitate in subjects with schizophrenia whose disease remained symptomatic despite recent treatment with oral risperidone...
- Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trialCynthia A Bossie
Ortho McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA
BMC Psychiatry 11:79. 2011..These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing: the time to onset of efficacy and the associated tolerability...
- A randomized, double-blind, placebo-controlled study of maintenance treatment with adjunctive risperidone long-acting therapy in patients with bipolar I disorder who relapse frequentlyWayne Macfadden
Ortho McNeil Janssen Scientific Affairs, LLC, Titusville, NJ 08560, USA
Bipolar Disord 11:827-39. 2009..This study assessed whether adjunctive maintenance treatment with risperidone long-acting therapy (RLAT), added to treatment-as-usual (TAU) medications for bipolar disorder, delays relapse in patients with bipolar disorder type I...
- Medication satisfaction in schizophrenia: a blinded-initiation study of paliperidone extended release in patients suboptimally responsive to risperidoneCarla M Canuso
Ortho McNeil Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Road A32404, Titusville, NJ 08560, USA
Int Clin Psychopharmacol 25:155-64. 2010..1%), constipation (7.6%), headache (7.6%) and somnolence (6.6%). Participants with schizophrenia who were suboptimally responsive to risperidone reported improved medication satisfaction after initiation of paliperidone ER...
- Expansion of guidance for the day 8 initiation dose of paliperidone palmitate to avoid a missed doseMahesh 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...
- Identification of clinically meaningful relationships among cognition, functionality, and symptoms in subjects with schizophrenia or schizoaffective disorderGahan Pandina
Janssen Research and Development, LLC, Titusville, NJ, USA
Schizophr Res 143:312-8. 2013..This study explored the relationships among cognitive functioning, clinical symptoms, overall functionality, and demographic characteristics...
- Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial dataMahesh 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...
- Clinical characteristics and resource utilization of patients with bipolar disorder who have frequent psychiatric interventionsJ Thomas Haskins
Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ 08560 0200, USA
J Med Econ 13:552-8. 2010....
- Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimensDong Jing Fu
Janssen Scientific Affairs, LLC, Titusville, NJ, USA
Clin Schizophr Relat Psychoses 8:101-9, 109A. 2014..To examine onset of efficacy of two long-acting injectable atypical antipsychotics in markedly-to-severely ill schizophrenia subjects...
- Body mass index and metabolic parameters in patients with schizophrenia during long-term treatment with paliperidone palmitateJennifer Kern Sliwa
Janssen Scientific Affairs, LLC, NJ, USA
BMC Psychiatry 14:52. 2014..We explored the relationship between body mass index (BMI) and metabolic events in patients with schizophrenia receiving long-acting injectable paliperidone palmitate (PP) in a long-term trial...
- Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophreniaJennifer Kern Sliwa
Janssen Scientific Affairs LLC, Titusville, NJ, USA
Neuropsychiatr Dis Treat 8:375-85. 2012....
- Antipsychotic adherence patterns and health care utilization and costs among patients discharged after a schizophrenia-related hospitalizationMichael Markowitz
Janssen Scientific Affairs, LLC, Titusville, New Jersey
BMC Psychiatry 13:246. 2013..e., before and after schizophrenia-related hospitalization) among Medicaid-enrolled patients experiencing a schizophrenia-related hospitalization...
- Management of antipsychotic treatment discontinuation and interruptions using model-based simulationsMahesh N Samtani
Janssen Research and Development, Raritan, NJ, USA
Clin Pharmacol 4:25-40. 2012..These pharmacokinetic model-based simulations analyze predicted antipsychotic plasma concentrations in nonadherence and treatment interruption scenarios and with treatment reinitiation...
- A Prospective Study Comparing the Long-term Effectiveness of Injectable Risperidone Long-acting Therapy and Oral Aripiprazole in Patients with SchizophreniaWayne Macfadden
Dr Macfadden was with Ortho McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey, at the time of this analysis Dr Macfadden currently is Medical Director at Princeton Medical Institute, Princeton, New Jersey Drs Ma and Haskins are with Johnson and Johnson Pharmaceutical Research and Development, LLC, Titusville, New Jersey and Drs Bossie and Alphs are with Ortho McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey
Psychiatry (Edgmont) 7:23-31. 2010....
- Safety of paliperidone extended-release in patients with schizophrenia or schizoaffective disorder and hepatic diseaseJoan Amatniek
Janssen Scientific Affairs, Bristol Myers Squibb, LLC, Titusville, NJ, Plainsboro, NJ, USA
Clin Schizophr Relat Psychoses 8:8-20. 2014..This multicenter, open-label, single-arm, crossover study evaluated the safety and efficacy of paliperidone extended-release (ER) in patients with schizophrenia or schizoaffective disorder and hepatic disease...
- Comparison of the Peak-to-trough Fluctuation in Plasma Concentration of Long-acting Injectable Antipsychotics and Their Oral EquivalentsJohn J Sheehan
Dr Sheehan was an employee of Janssen Scientific Affairs, LLC, Titusville, New Jersey, at the time of this analysis and is currently an employee of Bristol Myers Squibb, Plainsboro, New Jersey Drs Reilly, FU, and Alphs are employees of Janssen Scientific Affairs, LLC, Titusville, New Jersey
Innov Clin Neurosci 9:17-23. 2012..Further study is needed with more robust and generalizable peak-to-trough fluctuation data...