paliperidone palmitate profile

Paliperidone Palmitate: A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate : A fatty acid ester obtained by the formal condensation of the carboxy group of hexadecanoic acid with the hydroxy group of 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

paliperidone palmitate : A racemate comprising equimolar amounts of (R)- and (S)-paliperidone palmitate. A long-acting injectable formulation of paliperidone (the major active metabolite of risperidone) that is used for treatment of schizophrenia. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

ID Source	ID
PubMed CID	9852746
CHEMBL ID	2107360
CHEBI ID	83808
CHEBI ID	83807
SCHEMBL ID	1871384
SCHEMBL ID	12415674
MeSH ID	M0546009

Synonym
199739-10-1
9-hydroxyrisperidone palmitate
SCHEMBL1871384
r-092670
jns010
ro-92670
CHEMBL2107360
chebi:83808 ,
jns-010
palperidone palmitate
r092670
FT-0673476
unii-r8p8usm8fr
r8p8usm8fr ,
ro92670
xeplion
ro 92670
trinza
paliperidone palmitate
jns 010
(9rs)-3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido(1,2-a)pyrimidin-9-yl hexadecanoate
invega trinza
paliperidone palmitate [usan]
invega sustenna
hexadecanoic acid, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-4-oxo-4h-pyrido(1,2-a)pyrimidin-9-yl ester
S5624
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate
3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate
SCHEMBL12415674
AC-32485
palmitate, paliperidone
AKOS030526057
BCP08473
DTXSID70870217
Q27157250
HY-A0019A
[3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl] hexadecanoate
SB17398
hexadecanoic acid, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4h-pyrido[1,2-a]pyrimidin-9-yl ester
CS-0016387
mfcd24386477
NCGC00522023-01
3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-9-yl palmitate
D83646
hexadecanoic acid, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4h-pyrido[1,2-a]pyrimidin-9-yl ester; 9-hydroxyrisperidone palmitate; invega sustenna; paliperidone palmitate; ro 92670
AS-77089
paliperidone palmitate [jan]
(9rs)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate
paliperidone palmitate [who-dd]
paliperidone palmitate [orange book]
paliperidone janssen
paliperidone palmitate [ema epar]
paliperidone palmitate [mart.]
paliperidone palmitate [mi]
paliperidone palmitate [vandf]
pp3m
paliperidonepalmitate-d4
3-(2-(4-(6-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido[1,2-a]pyrimidin-9-ylpalmitate
chebi:83807
rac-paliperidone palmitate
(9rs)-3-(2-(4-(6-fluoro-1,2-benzoisoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido(1,2-a)pyrimidin-9-yl palmitate
trevicta
paliperidone palmitate (mart.)
(rs)-paliperidone palmitate
invega hafyera
(+-)-paliperidone palmitate
paliperidone hexadecanoate
rac-3-(2-(4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4h-pyrido(1,2-a)pyrimidin-9-yl hexadecanoate
racemic paliperidone palmitate

Excerpt	Reference	Relevance
"Paliperidone palmitate is a second generation antipsychotic, approved for the treatment of schizophrenia in the form of the long-acting injectable (LAI) products INVEGA SUSTENNA® (once monthly injection) and INVEGA TRINZA® (once every 3 months injection). "	( Need for Bioequivalence Standards that Reflect the Clinical Importance of the Complex Pharmacokinetics of Paliperidone Palmitate Long-Acting Injectable Suspension. Katzman, MA; Lamoure, JW; Procyshyn, RM; Sherman, SE; Skinner, PL, 2019)	2.17
"Paliperidone palmitate is an antipsychotic medication available as long-acting injectable (LAI) formulations. "	( Impact of age and gender on paliperidone exposure in patients after administration of long-acting injectable formulations-an observational study using blood samples from 1223 patients. Haslemo, T; Høiseth, G; Molden, E; Smith, RL; Tveito, M, 2021)	2.06
"Paliperidone palmitate (PP) is a recently introduced long-acting atypical, or second-generation, antipsychotic. "	( Long-acting paliperidone palmitate - interim results of an observational study of its effect on hospitalization. Olofinjana, O; Taylor, D, 2014)	2.22
"Paliperidone palmitate (PP) is a long-acting injectable (LAI) antipsychotic, developed for monthly intramuscular (i.m.) administration into deltoid/gluteal muscle, approved for the treatment of schizophrenia in many countries. "	( A single-dose, open-label, parallel, randomized, dose-proportionality study of paliperidone after intramuscular injections of paliperidone palmitate in the deltoid or gluteal muscle in patients with schizophrenia. Berwaerts, J; Cleton, A; Crauwels, H; De Meulder, M; Eerdekens, M; Gopal, S; Hough, D; Remmerie, B; Rossenu, S; Rosso, CM; Vandebosch, A, 2014)	2.05
"Paliperidone palmitate (PP) is a once-monthly long-acting injectable antipsychotic approved for the treatment of schizophrenia in many countries. "	( Pharmacokinetic profile after multiple deltoid or gluteal intramuscular injections of paliperidone palmitate in patients with schizophrenia. Berwaerts, J; Cleton, A; Crauwels, H; De Meulder, M; Eerdekens, M; Francetic, I; Herben, V; Hough, D; Remmerie, B; Rossenu, S; Vandebosch, A, 2015)	2.08
"Paliperidone palmitate is an investigational, injectable atypical antipsychotic. "	( Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Eerdekens, M; Gopal, S; Herben, V; Hough, D; Lim, P; Lindenmayer, JP; Melkote, R; Yuen, E, 2009)	2.04
"Paliperidone palmitate is a newly available depot formulation of paliperidone (the 9-OH metabolite of risperidone). "	( Paliperidone palmitate - review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Citrome, L, 2010)	3.25
"Paliperidone palmitate is a long-acting injectable antipsychotic agent. "	( A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Eerdekens, M; Gassmann-Mayer, C; Gopal, S; Hough, D; Lim, P; Nasrallah, HA; Quiroz, JA; Yuen, E, 2010)	2.07
"Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. "	( Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. Alphs, L; Bossie, CA; Fu, DJ; Ma, YW; Sliwa, JK, 2011)	2.04
"Paliperidone palmitate (PP) is a recently (USA) approved injectable new-generation antipsychotic. "	( A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Eerdekens, M; Fleischhacker, WW; Gassmann-Mayer, C; Gopal, S; Hough, D; Lane, R; Lim, P; Remmerie, B, 2012)	2.14
"Paliperidone palmitate is a second-generation, long-acting injectable (LAI) antipsychotic recently approved by the US FDA and European Medicines Agency for use in patients with schizophrenia. "	( Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data. Alphs, L; Gassmann-Mayer, C; Gopal, S; Palumbo, JM; Samtani, MN, 2011)	2.09
"Paliperidone Palmitate is a long-acting intramuscular atypical antipsychotic drug indicated for the acute maintenance treatment of schizophrenia in adults. "	( Clinical pharmacology of paliperidone palmitate a parenteral long-acting formulation for the treatment of schizophrenia. Gilday, E; Nasrallah, HA, 2012)	2.13
"Paliperidone palmitate is an atypical long-acting injectable (LAI) antipsychotic that has been approved for use in the US, EU, Australia and numerous other countries for acute and maintenance therapy of schizophrenia. "	( Practical guidelines on the use of paliperidone palmitate in schizophrenia. Hustig, H; Lakshmana, R; Lee, J; Motamarri, B; Newton, R; Norrie, P; Parker, R; Schreiner, A, 2012)	2.1

Excerpt	Reference	Relevance
"Paliperidone palmitate has been associated with serum prolactin elevations in some patients. "	( An analysis of potentially prolactin-related adverse events and abnormal prolactin values in randomized clinical trials with paliperidone palmitate. Coppola, D; Einarson, TR; Gopal, S; Hemels, ME; Hough, D; Nuamah, I, 2012)	2.03

Excerpt	Reference	Relevance
"Is paliperidone palmitate (PP) a useful treatment option for adults with acute symptoms of schizophrenia? We conducted a systematic review and a random-effects pairwise and network meta-analysis that compared PP (25-150 mg equivalent) with paliperidone extended-release (PAL-ER, 3-12 mg/d) regarding their efficacy and safety in adults with acute symptoms of schizophrenia. "	( Paliperidone palmitate vs. paliperidone extended-release for the acute treatment of adults with schizophrenia: a systematic review and pairwise and network meta-analysis. Iwata, N; Kishi, T; Sakuma, K, 2022)	2.79
"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."	( Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Eerdekens, M; Gopal, S; Herben, V; Hough, D; Lim, P; Lindenmayer, JP; Melkote, R; Yuen, E, 2009)	1.32
"Paliperidone palmitate treatment can be initiated the day after discontinuing previous oral antipsychotic treatment."	( Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. Alphs, L; Gassmann-Mayer, C; Gopal, S; Palumbo, J; Samtani, MN; Shiwach, R, 2010)	1.34
"Paliperidone palmitate treatment with this revised dosing regimen led to the achievement of rapid and consistent therapeutically effective plasma levels that were maintained by once-monthly dosing in either the deltoid or gluteal muscle."	( A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. Gopal, S; Herben, V; Kusumakar, V; Lim, P; Lindenmayer, JP; Lull, J; Palumbo, J; Pandina, GJ; Yuen, E, 2010)	1.3
"Treatment with paliperidone palmitate at doses between 39 and 156 mg significantly delayed the time to recurrence of symptoms of schizophrenia after 24 weeks of maintained symptom stability."	( Paliperidone palmitate - review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Citrome, L, 2010)	2.14
"Treatment with paliperidone palmitate (100 mg eq.) was efficacious and all doses tested were tolerable."	( Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Brown, DW; Eerdekens, MH; Gassmann-Mayer, C; Gopal, S; Hough, DW; Lull, JM; Remmerie, BM; Xu, H, 2010)	1.01

Excerpt	Reference	Relevance
" No correlation between the serum concentration of the active moiety and the side effects evaluated by the UKU Side Effect Scale was found."	( Serum concentrations and side effects in psychiatric patients during risperidone therapy. Bruun, T; Licht, RW; Linnet, K; Olesen, OV; Thomsen, E; Viftrup, JE, 1998)	0.3
" Galantamine and risperidone were both safe and well tolerated administered either alone or together."	( Pharmacokinetic and safety assessments of galantamine and risperidone after the two drugs are administered alone and together. Huang, F; Janssens, L; Lasseter, KC; Lau, H; Verhaeghe, T; Zhao, Q, 2002)	0.31
" Overall, it was well-tolerated and had placebo-like discontinuation rates for adverse events."	( Extended-release paliperidone: efficacy, safety and tolerability profile of a new atypical antipsychotic. Owen, RT, 2007)	0.34
" Paliperidone ER was associated with a low incidence of treatment-emergent adverse events."	( Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Davidson, M; Eerdekens, M; Emsley, R; Ford, L; Kramer, M; Lim, P; Pan, G, 2007)	0.34
" 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."	( Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Eerdekens, E; Eerdekens, M; Ford, L; Kramer, M; Lim, P; Lowy, A; Marder, SR, 2007)	0.34
" It has been developed as an osmotic controlled-release oral delivery system that minimizes peak-trough fluctuations in plasma concentrations, allowing once-daily administration and theoretically leading to a decreased incidence of adverse effects."	( The pharmacology and safety of paliperidone extended-release in the treatment of schizophrenia. Cavallaro, R; Spina, E, 2007)	0.34
" Measurements included adverse events, laboratory tests, physical examinations, 12-lead electrocardiograms, movement disorder rating scales, Positive and Negative Syndrome Scale, and Clinical Global Impression scale."	( Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Eerdekens, M; Ford, L; Gassmann-Mayer, C; Kramer, M; Lim, P; Samokhvalov, V; Tzimos, A, 2008)	0.35
" During the double-blind phase, discontinuation rates resulting from adverse events were similar between groups (paliperidone ER: 7%, placebo: 8%) as were incidences of treatment-emergent adverse events (paliperidone ER: 67%, placebo: 71%)."	( Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Eerdekens, M; Ford, L; Gassmann-Mayer, C; Kramer, M; Lim, P; Samokhvalov, V; Tzimos, A, 2008)	0.35
" Most commonly (> or =10% patients) reported adverse events (AEs) were insomnia, headache, and akathisia."	( Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies. Berwaerts, J; Eerdekens, M; Emsley, R; Hough, D; Kramer, M; Lane, R; Lim, P; Palumbo, J, 2008)	0.35
" The incidence of systemic treatment-emergent adverse events (TEAEs) was similar between the 2 injection sites across doses during period 1 (deltoid [D]: 61% to 67%; gluteus [G]: 58% to 65%), and during the last 8 weeks of the 2 study periods (DG: 32% to 45% [period 1], 29% to 42% [period 2]; GD: 31% to 40% [period 1], 30% to 41% [period 2])."	( Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Eerdekens, M; Gopal, S; Herben, V; Hough, D; Lim, P; Lindenmayer, JP; Melkote, R; Yuen, E, 2009)	0.59
" Assessments included PANSS, Clinical Global Impressions-Severity (CGI-S), Personal and Social Performance (PSP) scale, and adverse events (AEs)."	( Efficacy and safety of paliperidone extended-release in schizophrenia patients with prominent affective symptoms. Bossie, CA; Canuso, CM; Sheehan, JJ; Turkoz, I, 2010)	0.36
" In the safety analysis set (n=247), fewer PP-treated patients (2%) discontinued for treatment-emergent adverse events vs."	( Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Eerdekens, M; Hough, D; Kramer, M; Lane, R; Lim, P; Litman, R; Liu, Y, 2010)	1.8
" Common adverse events (in >or=2% of patients in any group) more frequent with paliperidone palmitate 50 or 100 mg eq."	( Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Brown, DW; Eerdekens, MH; Gassmann-Mayer, C; Gopal, S; Hough, DW; Lull, JM; Remmerie, BM; Xu, H, 2010)	0.9
" Common treatment-emergent adverse events (> or =2% of patients in any of the treatment groups) that occurred more frequently in the total paliperidone palmitate group versus the placebo group (with > or =1% difference) were injection-site pain (7."	( A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. Gopal, S; Herben, V; Kusumakar, V; Lim, P; Lindenmayer, JP; Lull, J; Palumbo, J; Pandina, GJ; Yuen, E, 2010)	0.79
" The most frequent (≥ 5% in total group) adverse events were insomnia (7%); worsening of schizophrenia; nasopharyngitis; headache; and weight increase (6% each)."	( A 52-week open-label study of the safety and tolerability of paliperidone palmitate in patients with schizophrenia. Eerdekens, M; Gopal, S; Hough, D; Lim, P; Morozova, M; Vijapurkar, U, 2011)	0.61
" Headache was the most common treatment-emergent adverse event (17% total paliperidone ER versus 12% placebo)."	( Evaluation of the efficacy and safety of paliperidone extended-release in the treatment of acute mania: a randomized, double-blind, dose-response study. Berwaerts, J; Hough, D; Lim, P; Nuamah, I; Xu, H, 2012)	0.38
" Safety and tolerability assessments included incidence of adverse events and extrapyramidal symptoms."	( One-year open-label safety and efficacy study of paliperidone extended-release tablets in patients with schizophrenia. Eerdekens, M; Hough, D; Kramer, M; Kushner, S; Lim, P; Liu, Y; Maciulis, V; Palumbo, J; Simpson, G, 2010)	0.36
" Twelve patients (5%) experienced an adverse event requiring treatment discontinuation."	( One-year open-label safety and efficacy study of paliperidone extended-release tablets in patients with schizophrenia. Eerdekens, M; Hough, D; Kramer, M; Kushner, S; Lim, P; Liu, Y; Maciulis, V; Palumbo, J; Simpson, G, 2010)	0.36
"Long-acting injectable (LAI) formulations of antipsychotics are valuable treatment alternatives for patients with psychotic disorders, and understanding their safe use is critical."	( Are the long-acting intramuscular formulations of risperidone or paliperidone palmitate associated with post-injection delirium/sedation syndrome? An assessment of safety databases. Alphs, L; Gopal, S; Karcher, K; Kent, J; Kushner, S; Nuamah, I; Singh, J; Sliwa, JK, 2011)	0.61
" No patient exhibited any noticeable prolongation of QTc interval and no adverse cardiac events, in particular arrhythmias, were noted."	( Cardiac safety of the electroconvulsive therapy-paliperidone combination: a preliminary study. Markatou, M; Masdrakis, VG; Oulis, P; Tzanoulinos, G, )	0.13
" In the studies analyzed it was well tolerated and the most frequent reported adverse events were mild extrapyramidal symptoms and an increase in serum prolactin levels."	( [Efficacy, tolerability and safety of paliperidone extended-release in the treatment of schizophrenia and schizoaffective disorder]. Bellantuono, C; Santone, G, )	0.13
"Paliperidone has been shown to be an effective and safe medication for the treatment of schizophrenia and schizoaffective disorder."	( [Efficacy, tolerability and safety of paliperidone extended-release in the treatment of schizophrenia and schizoaffective disorder]. Bellantuono, C; Santone, G, )	0.13
" Most frequent (≥ 10%) treatment-emergent adverse events were nasopharyngitis (n = 37), insomnia (n = 32), injection-site pain (n = 32), headache (n = 28), and tachycardia (n = 27)."	( A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia. Coppola, D; Gopal, S; Hough, DW; Liu, Y; Nuamah, I; Pandina, G; Remmerie, B; Samtani, MN; Sulaiman, A, 2012)	0.59
" Higher doses may provide additional benefit as well as dose-related increases in some adverse reactions."	( Oral paliperidone extended-release: chemistry, pharmacodynamics, pharmacokinetics and metabolism, clinical efficacy, safety and tolerability. Citrome, L, 2012)	0.38
" In this context, newer SGAs were developed to further improve the adverse effect burden of available agents."	( Body weight and metabolic adverse effects of asenapine, iloperidone, lurasidone and paliperidone in the treatment of schizophrenia and bipolar disorder: a systematic review and exploratory meta-analysis. Correll, CU; De Hert, M; Detraux, J; Sweers, K; van Winkel, R; Yu, W, 2012)	0.38
" However, few individuals with elevated prolactin levels (hyperprolactinemia) have symptomatic potentially prolactin-related adverse events (PPR-AEs)."	( An analysis of potentially prolactin-related adverse events and abnormal prolactin values in randomized clinical trials with paliperidone palmitate. Coppola, D; Einarson, TR; Gopal, S; Hemels, ME; Hough, D; Nuamah, I, 2012)	0.59
"Hyperprolactinemia is a common side effect in young males treated over the long term with risperidone."	( Risk of hyperprolactinemia and sexual side effects in males 10-20 years old diagnosed with autism spectrum disorders or disruptive behavior disorder and treated with risperidone. Boot, AM; Buitelaar, JK; Roke, Y; Tenback, D; van Harten, PN, 2012)	0.38
" Treatment-emergent adverse events (TEAEs), including those considered more relevant to antipsychotic treatment (prespecified adverse events [AEs]), were analyzed."	( Safety of paliperidone extended-release in patients with schizophrenia or schizoaffective disorder and hepatic disease. Alphs, L; Amatniek, J; Canuso, CM; Deutsch, SI; Henderson, DC; Mao, L; Mikesell, C; Rodriguez, S; Sheehan, J, 2014)	0.4
" The objective of this analysis was to report the results of a population pharmacokinetic analysis and to describe the relationship between risperidone and 9-hydroxyrisperidone levels with dopamine (DA) D2-receptor occupancy, prolactin levels, and adverse events using data collected in 45 clinically stable schizophrenic patients receiving RBP-7000 in single ascending doses (risperidone) of 60, 90, and 120 mg."	( A model-based approach to characterize the population pharmacokinetics and the relationship between the pharmacokinetic and safety profiles of RBP-7000, a new, long-acting, sustained-released formulation of risperidone. Fudala, PJ; Gomeni, R; Heidbreder, C; Nasser, AF, 2013)	0.39
" The conventional agents are also associated with adverse neurologic effects such as extrapyramidal symptoms (EPS)."	( Paliperidone extended-release: safety and tolerability from a metabolic profile perspective. Quilo, CG; Rodríguez-Martínez, A, 2013)	0.39
"7%), and adverse drug reaction (11."	( Toxicity and clinical outcomes of paliperidone exposures reported to U.S. Poison Centers. Anderson, B; Klein-Schwartz, W; Tsay, ME, 2014)	0.4
" The most common (>10% patients) treatment-emergent adverse events for paliperidone ER were akathisia, headache, somnolence, tremor, and weight gain, and for aripiprazole were worsening of schizophrenia and somnolence."	( Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study. Gopal, S; Hough, D; Lane, R; Nuamah, I; Savitz, AJ, 2015)	0.42
" In the DB phase, 183 of 305 patients (62% with 3-month paliperidone palmitate; 58% with placebo) had at least 1 treatment-emergent adverse event; those noted more frequently in the group receiving paliperidone palmitate than in the placebo group were headache (9% vs 4%), weight increased (9% vs 3%), nasopharyngitis (6% vs 1%), and akathisia (4% vs 1%)."	( Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. Berwaerts, J; Coppola, D; Gopal, S; Hough, DW; Liu, Y; Maruta, N; Nuamah, I; Remmerie, B; Savitz, A; Schotte, A; Xu, H, 2015)	0.92
" Headache and nasopharyngitis were the most common (>7%) treatment-emergent adverse events."	( Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: A phase-1, single-dose, randomized, open-label study. Chang, CT; De Meulder, M; Gopal, S; Hough, D; Nuamah, I; Ravenstijn, P; Remmerie, B; Samtani, MN; Savitz, A, 2016)	0.69
" Safety parameters were treatment-emergent adverse events (TEAEs), weight, Tanner staging, blood chemistry (including prolactin, glucose, insulin, and lipid levels), and extrapyramidal symptom (EPS) scales."	( Long-Term Safety of Paliperidone Extended Release in Adolescents with Schizophrenia: An Open-Label, Flexible Dose Study. Gopal, S; Hough, D; Lane, R; Nuamah, I; Savitz, A; Singh, J, 2015)	0.42
" Safety assessment variables included assessment of treatment emergent adverse events, clinical laboratory tests, vital sign measurements, ECG, Calgary Depression Scale for Schizophrenia (CDSS), mini-mental status examination, Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), Simpson-Angus Scale for the Assessment of Extrapyramidal Side Effects (SAS) and WHO Quality of Life-BREF (WHO-QOL-BREF)."	( Efficacy and safety of once-monthly paliperidone palmitate long-acting injection in an elderly patient with schizophrenia. Lewis, M; Macfarlane, S; Rama Raj, P, 2015)	0.69
" Both groups had similar tolerability profiles; increased weight was the most common treatment-emergent adverse event (double-blind phase; 21% each)."	( Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study. Fleischhacker, WW; Gopal, S; Hough, D; Janik, A; Nuamah, I; Ravenstijn, P; Savitz, AJ; Schotte, A; Xu, H, 2016)	0.74
" Paliperidone ER and PP are generally well tolerated with a predictable adverse event profile."	( Paliperidone for the treatment of schizophrenia and schizoaffective disorders - a drug safety evaluation. Altamura, AC; Di Pace, C; Mauri, MC; Paletta, S; Reggiori, A, 2017)	0.46
"We conducted a cross-sectional study using the Korea Adverse Event Reporting System database between July 1, 2010, and June 30, 2015."	( Current Status of Parkinsonism-Related Adverse Events and Associated Drugs in Korea. Kim, S; Suh, HS, 2019)	0.51
"There were 1402 adverse event reports associated with parkinsonism."	( Current Status of Parkinsonism-Related Adverse Events and Associated Drugs in Korea. Kim, S; Suh, HS, 2019)	0.51
"Metoclopramide and antipsychotics were reported in most adverse event reports associated with parkinsonism in Korea."	( Current Status of Parkinsonism-Related Adverse Events and Associated Drugs in Korea. Kim, S; Suh, HS, 2019)	0.51
"Overall, both 1-month and 3-month formulations of PDP are safe and effective in the treatment of schizophrenia and schizoaffective disorder."	( Long-Acting Injectable Paliperidone Palmitate: A Review of Efficacy and Safety. Morris, MT; Tarpada, SP, 2017)	0.77
"Elevated prolactin levels (hyperprolactinemia) are a frequent adverse effect of antipsychotic medications, especially in young populations."	( Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study. Bach, M; Copenhaver, M; Gopal, S; Hough, D; Lane, R; Nuamah, I; Savitz, A; Singh, J, 2017)	0.46
"This study assessed potentially prolactin-related treatment-emergent adverse events (PPRL-TEAEs) and sexual maturation during long-term treatment of adolescents with paliperidone extended-release (ER)."	( Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study. Bach, M; Copenhaver, M; Gopal, S; Hough, D; Lane, R; Nuamah, I; Savitz, A; Singh, J, 2017)	0.46
" All the patients were administered the Positive and Negative Syndrome Scale, the Clinical Global Impression, the Extrapyramidal Symptom Rating Scale, the UKU (Ugvalg for Kliniske Undersgelser) Side Effect Rating Scale, the Short Form 36, the Morisky Medication Adherence Scale, and the Schedule for Assessing the Three Components of Insight."	( Comparison of Paliperidone Palmitate and Second-Generation Oral Antipsychotics in Terms of Medication Adherence, Side Effects, and Quality of Life. Sağlam Aykut, D, )	0.49
" Treatment emergent adverse events with PP3M during DB phase were similar in Latin America (study A: 24/34 [70."	( Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Gopal, S; Mathews, M; Nuamah, I; Savitz, AJ; Soares, B; Xu, H, )	0.44
" Patients' characteristics, scale scores, and adverse events were recorded."	( Efficacy and Safety of Paliperidone Palmitate Treatment in Patients With Schizophrenia: A Real-World Multicenter, Retrospective, Mirror-Image Study. Atmaca, M; Baran, Z; Cengisiz, C; Çinar, C; Devrimci-Ozguven, H; Erol, A; Genç, Y; Karadağ, H; Karakülah, K; Karasu, U; Kaya, MC; Kizil, E; Özcan, H; Tiryaki, A; Üçok, A; Varlik, C; Yazar, SM; Yildiz, M, )	0.44
" The frequency of adverse events did not differ between the period before and during PP treatment."	( Efficacy and Safety of Paliperidone Palmitate Treatment in Patients With Schizophrenia: A Real-World Multicenter, Retrospective, Mirror-Image Study. Atmaca, M; Baran, Z; Cengisiz, C; Çinar, C; Devrimci-Ozguven, H; Erol, A; Genç, Y; Karadağ, H; Karakülah, K; Karasu, U; Kaya, MC; Kizil, E; Özcan, H; Tiryaki, A; Üçok, A; Varlik, C; Yazar, SM; Yildiz, M, )	0.44
"Paliperidone palmitate is effective and safe in treatment of schizophrenic patients and in switching to PP treatment in patients with schizophrenia, which reduced the percentage of patients admitted to the hospital for relapse and the median number hospitalization, and has positive effects on functionality."	( Efficacy and Safety of Paliperidone Palmitate Treatment in Patients With Schizophrenia: A Real-World Multicenter, Retrospective, Mirror-Image Study. Atmaca, M; Baran, Z; Cengisiz, C; Çinar, C; Devrimci-Ozguven, H; Erol, A; Genç, Y; Karadağ, H; Karakülah, K; Karasu, U; Kaya, MC; Kizil, E; Özcan, H; Tiryaki, A; Üçok, A; Varlik, C; Yazar, SM; Yildiz, M, )	1.88
" Adverse events (AEs) and laboratory data were monitored."	( Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. Bidollari, I; Cash, E; Claxton, A; Du, Y; Keane, E; Kunovac, J; Walling, DP; Weiden, PJ; Yagoda, S; Yao, B, 2020)	0.56
" Several case reports about unexpected adverse drug reactions of paliperidone have been consistently reported around the world."	( Signals of Adverse Drug Reactions of Paliperidone Compared to Other Atypical Antipsychotics Using the Korean Adverse Event Reporting System Database. Kim, S; Park, BJ; Seo, DE, 2020)	0.56
" Patient-reported sexual and endocrine side effects were assessed on the UKU Side Effect Rating Scale sexual function subscale and analyzed in study completers."	( Analysis of prolactin and sexual side effects in patients with schizophrenia who switched from paliperidone palmitate to aripiprazole lauroxil. Bidollari, I; Claxton, A; Du, Y; Kelly, DL, 2021)	0.84
"We conducted a chart review to investigate the detailed outcomes of patients with schizophrenia who discontinued long-acting injectable second-generation antipsychotic (LAI-SGA) therapy due to adverse events (AEs)."	( Outcomes of patients with schizophrenia who discontinued long-acting injectable antipsychotic therapy due to adverse events: A chart review. Hatano, M; Iwata, N; Kishi, T; Okuya, M; Sakuma, K, 2021)	0.62
"All of these diverse approaches were clinically relevant in enhancing treatment adherence and found to be safe and tolerable."	( New approaches to antipsychotic medication adherence - safety, tolerability and acceptability. Krivoy, A; Shergill, SS; Taub, S; Whiskey, E, 2022)	0.72
"Retrospective studies using spontaneous reporting system databases have provided a great understanding of adverse drug reactions (ADRs) in the real world, complementing the data obtained from randomized controlled trials."	( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019. Byeon, SJ; Chung, SJ; Oh, S, 2022)	0.72
"Data were collected from the Korea Adverse Event Reporting System database between 2010 and 2019."	( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019. Byeon, SJ; Chung, SJ; Oh, S, 2022)	0.72
"In total, 5067 adverse events associated with antipsychotic drugs were reported."	( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019. Byeon, SJ; Chung, SJ; Oh, S, 2022)	0.72
" Safety was assessed by treatment-emergent adverse events (TEAEs), physical examinations, and laboratory tests."	( Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia. Aravind, S; Galderisi, S; Knight, RK; Lamaison, HF; Najarian, D; Richarz, U; Turkoz, I; Zalitacz, P, 2023)	0.91
" The secondary outcomes included the changed number of inpatient visits, changed length of stay hospitalisation, change from baseline in the Clinical Global Impressions-Severity (CGI-S) score and the personal and social performance (PSP) total score, response rate, proportion of treatment discontinuation, and adverse events."	( Effectiveness and Safety of Switching from Oral Antipsychotics to Once-Monthly Paliperidone Palmitate (PP1M) in the Management of Schizophrenia: A Systematic Review and Meta-Analysis. Jia, M; Li, Q; Li, X; Si, T; Ye, C, 2023)	1.14
" Low discontinuation and adverse event rates were reported."	( Effectiveness and Safety of Switching from Oral Antipsychotics to Once-Monthly Paliperidone Palmitate (PP1M) in the Management of Schizophrenia: A Systematic Review and Meta-Analysis. Jia, M; Li, Q; Li, X; Si, T; Ye, C, 2023)	1.14

Excerpt	Reference	Relevance
"An open-label study evaluated the effect of steady-state venlafaxine on the single-dose pharmacokinetic profile of risperidone, a CYP2D6 substrate; its active metabolite, 9-hydroxyrisperidone; and the total active moiety (risperidone plus 9-hydroxyrisperidone)."	( Effect of venlafaxine on the pharmacokinetics of risperidone. Albano, D; Amchin, J; Klockowski, PM; Taylor, KP; Zarycranski, W, 1999)	0.3
"Following an oral dose of risperidone (RSP), concentrations of its major metabolite 9-hydroxyrisperidone (9-OHRSP) were high in plasma and tissues but disproportionately lower in the brain compared to RSP, indicating that 9-OHRSP may have different pharmacokinetic properties."	( Brain, plasma and tissue pharmacokinetics of risperidone and 9-hydroxyrisperidone after separate oral administration to rats. Aravagiri, M; Marder, SR, 2002)	0.31
" The terminal elimination half-life (t(1/2) ) of RSP after the RSP dose was longest in the liver (17."	( Brain, plasma and tissue pharmacokinetics of risperidone and 9-hydroxyrisperidone after separate oral administration to rats. Aravagiri, M; Marder, SR, 2002)	0.31
"To explore the steady-state pharmacokinetic profile after coadministration of galantamine and risperidone, an open-label, randomized, single-center, two-way crossover drug-drug interaction study was conducted in 16 healthy elderly subjects, ages 60 years and older."	( Pharmacokinetic and safety assessments of galantamine and risperidone after the two drugs are administered alone and together. Huang, F; Janssens, L; Lasseter, KC; Lau, H; Verhaeghe, T; Zhao, Q, 2002)	0.31
" Blood samples for pharmacokinetic analysis of the active moiety (risperidone + 9-hydroxy-risperidone), risperidone, and its active metabolite 9-hydroxy-risperidone were obtained during a 96-hour period after dosing."	( Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteers. Ko, G; Lasseter, KC; Lechat, P; Mannaert, E; Remmerie, BM; van Schaick, EA, 2003)	0.32
"The bioequivalence assessment was based on pharmacokinetic and statistical analysis of data from 37 subjects who completed both treatment periods."	( Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteers. Ko, G; Lasseter, KC; Lechat, P; Mannaert, E; Remmerie, BM; van Schaick, EA, 2003)	0.32
" The AUC from 0 to 24 hours of 9-hydroxyrisperidone, but not other pharmacokinetic parameters, was significantly increased during verapamil treatment."	( Effect of verapamil on pharmacokinetics and pharmacodynamics of risperidone: in vivo evidence of involvement of P-glycoprotein in risperidone disposition. Kaneo, S; Nakagami, T; Saito, M; Tateishi, T; Yasui-Furukori, N, 2005)	0.33
"A population model was developed with the aim to simultaneously describe risperidone and 9-hydroxyrisperidone pharmacokinetics; to obtain estimates for pharmacokinetic parameters and associated inter- and intra-individual variability of risperidone and 9-hydroxyrisperidone; and to evaluate the influence of patient demographic characteristics and other factors on risperidone, 9-hydroxyrisperidone, and active moiety pharmacokinetics."	( Population pharmacokinetics of risperidone and 9-hydroxyrisperidone in patients with acute episodes associated with bipolar I disorder. Ludwig, EA; Piotrovsky, V; Vermeulen, A, 2007)	0.34
"To develop a parent-metabolite pharmacokinetic model for risperidone (RIP) and its major active metabolite (9-hydroxyrisperidone) and investigate their pharmacokinetics characteristics in healthy male volunteers, twenty-two healthy volunteers were orally given a single dose of 2 mg RIP."	( [Development and identifiability analysis of parent-metabolite pharmacokinetic model for risperidone and its main active metabolite 9-hydroxyrisperidone]. Ding, JJ; Jiao, Z; Shi, XJ; Yu, YQ, 2007)	0.34
"The goals of this study were to estimate the pharmacokinetic parameters of risperidone and its enantiomers in a pediatric population and explore relationships between saliva and plasma concentrations."	( Plasma pharmacokinetic characteristics of risperidone and their relationship to saliva concentrations in children with psychiatric or neurodevelopmental disorders. Aman, MG; Lindsay, RL; Malone, K; Mannaert, E; Masty, J; Ramadan, Y; Remmerie, B; Vinks, AA, 2007)	0.34
" Standard pharmacokinetic parameters were calculated."	( Plasma pharmacokinetic characteristics of risperidone and their relationship to saliva concentrations in children with psychiatric or neurodevelopmental disorders. Aman, MG; Lindsay, RL; Malone, K; Mannaert, E; Masty, J; Ramadan, Y; Remmerie, B; Vinks, AA, 2007)	0.34
"In this preliminary pharmacokinetic study of parameters for risperidone and the enantiomers of 9-OH-risperidone in a pediatric population, mean C(max) and t(1/2) of risperidone were generally similar to those previously described in adults."	( Plasma pharmacokinetic characteristics of risperidone and their relationship to saliva concentrations in children with psychiatric or neurodevelopmental disorders. Aman, MG; Lindsay, RL; Malone, K; Mannaert, E; Masty, J; Ramadan, Y; Remmerie, B; Vinks, AA, 2007)	0.34
"3 mg/kg haloperidol, however, exhibited similar pharmacodynamic effects in both genotypes."	( Pharmacodynamic consequences of P-glycoprotein-dependent pharmacokinetics of risperidone and haloperidol in mice. Henken, S; Hiemke, C; Kirschbaum, KM; Schmitt, U, 2008)	0.35
" These long-term effects would not be captured by a standard 5-day pharmacokinetic TDM developmental testing model for antipsychotics, and a new model for characterizing variation in C/D by time course is therefore proposed."	( Long-term therapeutic drug monitoring of risperidone and olanzapine identifies altered steady-state pharmacokinetics: a clinical, two-group, naturalistic study. Darby, JK; Herbert, J; Pasta, DJ; Wilson, MG, 2008)	0.35
"To characterize pharmacokinetic (PK) variability of risperidone and 9-OH risperidone using sparse sampling and to evaluate the effect of covariates on PK parameters."	( Population pharmacokinetic analysis for risperidone using highly sparse sampling measurements from the CATIE study. Aravagiri, M; Bies, RR; Coley, K; Feng, Y; Kirshner, M; Marder, S; Miller, D; Pollock, BG; Schneider, L, 2008)	0.35
"This randomized, crossover study examined the effects of paroxetine (a potent CYP2D6 inhibitor) on the pharmacokinetic parameters of a single dose of the novel antipsychotic agent, paliperidone extended-release tablets (paliperidone ER), in healthy subjects."	( The effects of paroxetine on the pharmacokinetics of paliperidone extended-release tablets. Berwaerts, J; Chang, I; Cleton, A; Eerdekens, M; Herben, V; van de Vliet, I; van Hoek, P, 2009)	0.35
"Results suggest that no clinically relevant pharmacokinetic interaction occurs when paroxetine and paliperidone ER are co-administered and, therefore, initiation or discontinuation of concomitant treatment with CYP2D6-inhibiting drugs does not appear to warrant an adjustment in paliperidone ER dosage."	( The effects of paroxetine on the pharmacokinetics of paliperidone extended-release tablets. Berwaerts, J; Chang, I; Cleton, A; Eerdekens, M; Herben, V; van de Vliet, I; van Hoek, P, 2009)	0.35
" Paliperidone is eliminated with a terminal half-life of approximately 24 hours."	( Single- and multiple-dose pharmacokinetics and dose proportionality of the psychotropic agent paliperidone extended release. Boom, S; Cleton, A; De Meulder, M; Eerdekens, M; Janssens, L; Remmerie, B; Rossenu, S; Talluri, K; van Osselaer, N, 2009)	0.35
" A total of 18 530 pharmacokinetic samples with valid concentration timepoints were available for this analysis."	( Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Samtani, MN; Stuyckens, K; Vermeulen, A, 2009)	0.61
"A dual-absorption pharmacokinetic model best described the complex pharmacokinetics of paliperidone after intramuscular administration of its palmitate ester."	( Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Samtani, MN; Stuyckens, K; Vermeulen, A, 2009)	0.61
" The limited available paliperidone pharmacokinetic information suggests that there are four minor metabolic pathways."	( The pharmacokinetics of paliperidone versus risperidone. de Leon, J; Sandson, NB; Wynn, G, )	0.13
" Plasma paliperidone concentrations were determined, and pharmacokinetic parameters were analyzed."	( Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects. Guo, C; Liu, Y; Shu, L; Si, T; Su, YA; Zhang, H, 2010)	0.36
"Paliperidone's disposition after oral administration was characterized by a one-compartment pharmacokinetic model."	( Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects. Guo, C; Liu, Y; Shu, L; Si, T; Su, YA; Zhang, H, 2010)	0.36
"The pharmacokinetic results obtained in Chinese subjects were similar to those obtained in Japanese and Caucasian subjects."	( Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects. Guo, C; Liu, Y; Shu, L; Si, T; Su, YA; Zhang, H, 2010)	0.36
"Data regarding the pharmacokinetic properties of risperidone in the Thai population are limited."	( Relative bioavailability and pharmacokinetic comparison of two 2-mg risperidone tablet formulations: A single dose, randomized-sequence, double-blind, 2-way crossover study in healthy male volunteers in Thailand. Boonleang, J; Mahatthanatrakul, W; Pipatrattanaseree, W; Tanthana, C, 2010)	0.36
"The aim of this study was to evaluate and compare the pharmacokinetic properties of risperidone and its active metabolite, 9-hydroxyrisperidone (which reportedly contributes to the drug's pharmacodynamic effects), in a newly developed generic tablet formulation (test) and a branded formulation (reference) in healthy, fasting, male Thai volunteers."	( Relative bioavailability and pharmacokinetic comparison of two 2-mg risperidone tablet formulations: A single dose, randomized-sequence, double-blind, 2-way crossover study in healthy male volunteers in Thailand. Boonleang, J; Mahatthanatrakul, W; Pipatrattanaseree, W; Tanthana, C, 2010)	0.36
" The effects of formulation, period, sequence, and subject (within sequence) on pharmacokinetic parameters were analyzed using ANOVA."	( Relative bioavailability and pharmacokinetic comparison of two 2-mg risperidone tablet formulations: A single dose, randomized-sequence, double-blind, 2-way crossover study in healthy male volunteers in Thailand. Boonleang, J; Mahatthanatrakul, W; Pipatrattanaseree, W; Tanthana, C, 2010)	0.36
" The ANOVA suggested no statistically significant effect of formulation, period, or sequence on the studied pharmacokinetic parameters of the active moiety, risperidone, or 9-hydroxyrisperidone."	( Relative bioavailability and pharmacokinetic comparison of two 2-mg risperidone tablet formulations: A single dose, randomized-sequence, double-blind, 2-way crossover study in healthy male volunteers in Thailand. Boonleang, J; Mahatthanatrakul, W; Pipatrattanaseree, W; Tanthana, C, 2010)	0.36
"The single-dose pharmacokinetic data in this small, all-male, selected sample of fasting, healthy volunteers met Thailand's regulatory criteria for assuming bioequivalence of the tested generic and reference 2-mg risperidone tablets."	( Relative bioavailability and pharmacokinetic comparison of two 2-mg risperidone tablet formulations: A single dose, randomized-sequence, double-blind, 2-way crossover study in healthy male volunteers in Thailand. Boonleang, J; Mahatthanatrakul, W; Pipatrattanaseree, W; Tanthana, C, 2010)	0.36
"Significant differences were observed between the ABCB1 3435C>T genotypes for the pharmacokinetic parameters (peak serum concentration) of risperidone and the active moiety (risperidone and its main metabolite, 9-hydroxyrisperidone)."	( Influence of ABCB1 genetic polymorphisms on the pharmacokinetics of risperidone in healthy subjects with CYP2D610/10. Cho, HY; Kang, HA; Lee, IK; Lee, SN; Lee, YB; Yoo, HD, 2011)	0.37
" The dosing recommendations that were approved by the FDA and other regulatory agencies around the world are based on the results of population pharmacokinetic (PK) simulations and data from clinical trials that are presented in this review."	( Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data. Alphs, L; Gassmann-Mayer, C; Gopal, S; Palumbo, JM; Samtani, MN, 2011)	0.64
"Due to high interindividual variability in peripheral pharmacokinetic parameters, dosing of antipsychotics relies on clinical trial and error."	( Predicting plasma concentration of risperidone associated with dosage change: a population pharmacokinetic study. Bies, RR; Mamo, DC; Mimura, M; Pollock, BG; Suzuki, T; Tsunoda, K; Uchida, H; Watanabe, K, 2012)	0.38
" We conducted the population pharmacokinetic analysis of risperidone and 9-hydroxyrisperidone using a nonlinear mixed effects modeling (NONMEM) method and explored the possible influence of genetic polymorphisms in CYP2D6 alleles and ABCB1 (2677G>T/A and 3435C>T) on the population pharmacokinetics of risperidone and 9-hydroxyrisperidone."	( Population pharmacokinetic analysis of risperidone and 9-hydroxyrisperidone with genetic polymorphisms of CYP2D6 and ABCB1. Cho, HY; Lee, SN; Lee, YB; Yoo, HD; Yoon, H, 2012)	0.38
"The purpose of this review is to describe the pharmacokinetic profile of paliperidone and its clinical implications in the treatment of schizophrenia and schizoaffective disorder."	( Oral paliperidone extended-release: chemistry, pharmacodynamics, pharmacokinetics and metabolism, clinical efficacy, safety and tolerability. Citrome, L, 2012)	0.38
"The study aims were to characterize risperidone and (±)-9-hydroxyrisperidone pharmacokinetic (PK) variability in children and adolescents and to evaluate covariate effects on PK parameters."	( Population pharmacokinetic modeling of risperidone and 9-hydroxyrisperidone to estimate CYP2D6 subpopulations in children and adolescents. Aman, MG; Bies, RR; Saldaña, SN; Sherwin, CM; Vinks, AA, 2012)	0.38
"05), while the other pharmacokinetic parameters did not show any significant differences."	( Effects of single or repeated silymarin administration on pharmacokinetics of risperidone and its major metabolite, 9-hydroxyrisperidone in rats. Chae, SW; Choi, JM; Lee, HJ; Lee, KS; Park, JH; Rhie, SJ, 2013)	0.39
" The objective of this analysis was to report the results of a population pharmacokinetic analysis and to describe the relationship between risperidone and 9-hydroxyrisperidone levels with dopamine (DA) D2-receptor occupancy, prolactin levels, and adverse events using data collected in 45 clinically stable schizophrenic patients receiving RBP-7000 in single ascending doses (risperidone) of 60, 90, and 120 mg."	( A model-based approach to characterize the population pharmacokinetics and the relationship between the pharmacokinetic and safety profiles of RBP-7000, a new, long-acting, sustained-released formulation of risperidone. Fudala, PJ; Gomeni, R; Heidbreder, C; Nasser, AF, 2013)	0.39
" An integrated population pharmacokinetic model describing simultaneously risperidone and 9-hydroxyrisperidone after risperidone oral intake and RBP-7000 administration was developed in NON-MEM using 5,232 quantifiable plasma concentrations."	( Population pharmacokinetics and prediction of dopamine D2 receptor occupancy after multiple doses of RBP-7000, a new sustained-release formulation of risperidone, in schizophrenia patients on stable oral risperidone treatment. Fudala, PJ; Gomeni, R; Heidbreder, C; Laffont, CM; Nasser, AF; Zheng, B, 2014)	0.4
" The pharmacokinetic (PK) parameters, such as time to maximum concentration, t1/2, and CL/F, were comparable across the three treatment groups (p = 0."	( Pharmacokinetics and tolerability of paliperidone palmitate injection in Chinese subjects. Li, H; Liu, Y; Rui, Q; Shu, L; Si, T; Su, Y; Zhang, H, 2014)	0.68
" The objective of this study was to use pharmacokinetic and pharmacodynamic modeling tools to relate CAT with D2RO in rats and to compare that with the relationship between D2RO and EPS in humans."	( Dopamine D2 receptor occupancy as a predictor of catalepsy in rats: a pharmacokinetic-pharmacodynamic modeling approach. Barton, HA; Danhof, M; de Greef, R; Grimwood, S; Groothuis, GM; Johnson, M; Kozielska, M; Pilla Reddy, V; Proost, JH; Vermeulen, A, 2014)	0.4
" Pharmacodynamic assessments (apomorphine-induced compulsive behavior and spontaneous motor activity) were performed using mice."	( Paliperidone microemulsion for nose-to-brain targeted drug delivery system: pharmacodynamic and pharmacokinetic evaluation. Bhatt, KK; Gaikwad, RV; Patel, BG; Patel, MR; Patel, RB, 2016)	0.43
" A population pharmacokinetic model of RBP-7000 was developed in 90 clinically stable schizophrenic patients having received single/repeated doses of 60, 90, or 120 mg."	( Population pharmacokinetic modeling and simulation to guide dose selection for RBP-7000, a new sustained-release formulation of risperidone. Fudala, PJ; Gomeni, R; Heidbreder, C; Laffont, CM; Nasser, AF; Zheng, B, 2015)	0.42
" The validated UPLC method was successfully applied to the pharmacokinetic study of RIS and 9-OHRIS in human plasma."	( Concurrent determination of olanzapine, risperidone and 9-hydroxyrisperidone in human plasma by ultra performance liquid chromatography with diode array detection method: application to pharmacokinetic study. Ramanathan, M; Siva Selva Kumar, M, 2016)	0.43
"Using a population pharmacokinetic approach, we aimed to characterize the genetic and non-genetic sources of variability affecting risperidone and 9-hydroxyrisperidone pharmacokinetics, and relate them to common side effects."	( Genetics-Based Population Pharmacokinetics and Pharmacodynamics of Risperidone in a Psychiatric Cohort. Choong, E; Conus, P; Csajka, C; Eap, CB; Guidi, M; Vandenberghe, F; von Gunten, A, 2015)	0.42
" Peak paliperidone plasma concentration was achieved between 23 and 34 days, and apparent half-life was ∼2-4 months."	( Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: A phase-1, single-dose, randomized, open-label study. Chang, CT; De Meulder, M; Gopal, S; Hough, D; Nuamah, I; Ravenstijn, P; Remmerie, B; Samtani, MN; Savitz, A, 2016)	0.69
"29); Cmax : 62."	( Effect of carbamazepine on the pharmacokinetics of paliperidone extended-release tablets at steady-state. Berwaerts, J; Cleton, A; Kerbusch-Herben, V; Remmerie, B; Vandebosch, A, 2014)	0.4
" To evaluate the different injection-site options, we compared the pharmacokinetic profile of paliperidone after multiple injections of PP 100 mg eq."	( Pharmacokinetic profile after multiple deltoid or gluteal intramuscular injections of paliperidone palmitate in patients with schizophrenia. Berwaerts, J; Cleton, A; Crauwels, H; De Meulder, M; Eerdekens, M; Francetic, I; Herben, V; Hough, D; Remmerie, B; Rossenu, S; Vandebosch, A, 2015)	0.64
"Our data show a potential pharmacokinetic interaction, most likely via CYP3A4 between amlodipine and RIS, reflected in significantly different C/Ds for RIS, 9-OH-RIS and AM."	( Pharmacokinetic considerations in the treatment of hypertension in risperidone-medicated patients - thinking of clinically relevant CYP2D6 interactions. Gründer, G; Haen, E; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Schruers, KR; Stegmann, B; Walther, S, 2016)	0.43
" The objective of the study was to identify pharmacokinetic interactions of different mood stabilizers on the metabolism of risperidone (RIS) under natural conditions."	( Pharmacokinetic Drug-Drug Interactions of Mood Stabilizers and Risperidone in Patients Under Combined Treatment. Gründer, G; Haen, E; Hiemke, C; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Schruers, KR; Stegmann, B, 2016)	0.43
"The data give evidence for pharmacokinetic interactions between RIS and different anticonvulsant mood stabilizers."	( Pharmacokinetic Drug-Drug Interactions of Mood Stabilizers and Risperidone in Patients Under Combined Treatment. Gründer, G; Haen, E; Hiemke, C; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Schruers, KR; Stegmann, B, 2016)	0.43
"To disentangle an association between tobacco smoking, smoking habits and pharmacokinetic patterns such as plasma concentrations of risperidone (RIS), its active metabolite 9-hydroxyrisperidone (9-OH-RIS) and the active moiety, AM, (RIS+9-OH-RIS) in a naturalistic sample."	( Effect of smoking on risperidone pharmacokinetics - A multifactorial approach to better predict the influence on drug metabolism. Gründer, G; Haen, E; Hiemke, C; Paulzen, M; Schoretsanitis, G; Stegmann, B, 2017)	0.46
"011) for the group of moderate smokers while other pharmacokinetic parameters did not differ."	( Effect of smoking on risperidone pharmacokinetics - A multifactorial approach to better predict the influence on drug metabolism. Gründer, G; Haen, E; Hiemke, C; Paulzen, M; Schoretsanitis, G; Stegmann, B, 2017)	0.46
" This article reviews the pharmacokinetic rationale for the approved dosing regimens for PP3M, dosing windows, management of missed doses and treatment discontinuation, switching to other formulations, and dosing in special populations."	( Dosing and Switching Strategies for Paliperidone Palmitate 3-Month Formulation in Patients with Schizophrenia Based on Population Pharmacokinetic Modeling and Simulation, and Clinical Trial Data. Jonsson, EN; Magnusson, MO; Plan, EL; Rossenu, S; Russu, A; Samtani, MN; Vermeulen, A, 2017)	0.73
" The purpose of this paper is to provide a clinically oriented review of the pharmacokinetic and pharmacodynamic properties of paliperidone including receptor binding, clinical efficacy, safety and tolerability."	( Pharmacokinetic drug evaluation of paliperidone in the treatment of schizoaffective disorder. Macaluso, M; Oliver, H; Sohail, Z, 2017)	0.46
"We assessed the dosage strengths of paliperidone palmitate 1-month (PP1M) long-acting injectable resulting in similar steady-state (SS) exposures to the dosage strengths of oral risperidone using pharmacokinetic (PK) simulations."	( Maintenance dose conversion between oral risperidone and paliperidone palmitate 1 month: Practical guidance based on pharmacokinetic simulations. Gopal, S; Kern Sliwa, J; Kim, E; Mathews, M; Ravenstijn, P; Russu, A; Singh, A, 2018)	1
" The goal of this study was to develop a physiologically based pharmacokinetic (PBPK) model considering the CYP2D6 genetic polymorphism for risperidone and 9-hydroxyrisperidone (9-OH-RIS) taking CYP3A4 into account."	( Physiologically Based Pharmacokinetic Modelling to Describe the Pharmacokinetics of Risperidone and 9-Hydroxyrisperidone According to Cytochrome P450 2D6 Phenotypes. Abad-Santos, F; Hempel, G; Kneller, LA, 2020)	0.56
" The pharmacokinetic (PK) profile of the INVEGA SUSTENNA® formulation is biphasic, comprised of an initial relatively fast zero-order input, which allows rapid attainment of therapeutic concentrations without oral supplementation; and a subsequent maintained second-stage, first-order input, allowing for once monthly administration."	( Need for Bioequivalence Standards that Reflect the Clinical Importance of the Complex Pharmacokinetics of Paliperidone Palmitate Long-Acting Injectable Suspension. Katzman, MA; Lamoure, JW; Procyshyn, RM; Sherman, SE; Skinner, PL, 2019)	0.73
" These data (Japanese, n = 509; Korean, n = 31; Taiwanese, n = 47) were used to describe the paliperidone palmitate pharmacokinetics in Japanese, to compare with non-Japanese, and to validate the historical population pharmacokinetic (Pop-PK) model for paliperidone palmitate, developed using data from studies in patients with schizophrenia outside Japan."	( Population Pharmacokinetics of Paliperidone Palmitate (Once-Monthly Formulation) in Japanese, Korean, and Taiwanese Patients With Schizophrenia. De Meulder, M; Gopal, S; Neyens, M; Remmerie, B; Samtani, MN; Shimizu, H; Tsukamoto, Y, 2020)	1.06
" The goal of the study was to develop physiologically based pharmacokinetic (PBPK) models for the elderly aged 65+ years."	( Modelling Age-Related Changes in the Pharmacokinetics of Risperidone and 9-Hydroxyrisperidone in Different CYP2D6 Phenotypes Using a Physiologically Based Pharmacokinetic Approach. Hempel, G; Kneller, LA, 2020)	0.56
" Overall, age-related changes of the pharmacokinetics in the elderly were mainly observed in Cmax and AUC."	( Modelling Age-Related Changes in the Pharmacokinetics of Risperidone and 9-Hydroxyrisperidone in Different CYP2D6 Phenotypes Using a Physiologically Based Pharmacokinetic Approach. Hempel, G; Kneller, LA, 2020)	0.56
"The objective of this study was to investigate associations between pharmacokinetic correlates and once-monthly paliperidone palmitate (PP1M)-related adverse drug reactions (ADRs)."	( Pharmacokinetic Correlates of Once-Monthly Paliperidone Palmitate-Related Adverse Drug Reactions. Carpi, F; Conca, A; Endres, K; Gründer, G; Haen, E; Hiemke, C; Paulzen, M; Piacentino, D; Schoretsanitis, G, 2021)	1.1
" The rate of removal of LAIs is regulated by the slow rate of absorption in the site of injection and the phenomenon of their increased half-life is called flip-flop pharmacokinetics."	( [Clinical pharmacokinetics and pharmaceutical forms of long-acting injectable antipsychotics]. Kyziridis, TC, 2022)	0.72
" A population pharmacokinetic (PPK) modeling and simulation approach was implemented to identify TV-46000 doses and dosing schedules for clinical development that would provide the best balance between clinical efficacy and safety."	( Population Pharmacokinetic Modeling and Simulation of TV-46000: A Long-Acting Injectable Formulation of Risperidone. Elgart, A; Gomeni, R; Harary, E; Kalmanczhelyi, A; Lamson, M; Levi, M; Loupe, P; Merenlender Wagner, A; Perlstein, I; Spiegelstein, O; Tiver, R, 2022)	0.72
"This study aimed to determine the effects of pregnancy and ontogeny on risperidone and paliperidone pharmacokinetics by assessing their serum concentrations in two subjects and constructing a customized physiologically-based pharmacokinetic (PBPK) model."	( Physiologically-based pharmacokinetic model to investigate the effect of pregnancy on risperidone and paliperidone pharmacokinetics: Application to a pregnant woman and her neonate. Fujioka, K; Fujiwara, N; Horai, T; Iijima, K; Imafuku, H; Ito, T; Mahdy, WYB; Omura, T; Otsuka, I; Yamamoto, K; Yano, I, 2023)	0.91

Excerpt	Reference	Relevance
" In conclusion, both Risp and OH-Risp interact with P-gp in vitro, and P-gp has a profound effect on Risp and OH-Risp distribution over the BBB, as is evident from the knock-out mice experiments."	( P-glycoprotein interaction with risperidone and 9-OH-risperidone studied in vitro, in knock-out mice and in drug-drug interaction experiments. Ejsing, TB; Linnet, K; Pedersen, AD, 2005)	0.33
"The combination of anticonvulsant mood stabilizers with antipsychotic drugs may lead to clinically relevant drug-drug interactions."	( Pharmacokinetic Drug-Drug Interactions of Mood Stabilizers and Risperidone in Patients Under Combined Treatment. Gründer, G; Haen, E; Hiemke, C; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Schruers, KR; Stegmann, B, 2016)	0.43

Excerpt	Reference	Relevance
"The bioavailability of risperidone was evaluated in an open-label, randomized, two-way, crossover study comparing a 1-mg tablet with a 1-mg/ml oral solution."	( Risperidone: effects of formulations on oral bioavailability. Gutierrez, R; Huang, ML; Lee, PI; Woestenborghs, R, )	0.13
" The results showed that risperidone, when administered with galantamine, did not change the bioavailability of galantamine at steady state."	( Pharmacokinetic and safety assessments of galantamine and risperidone after the two drugs are administered alone and together. Huang, F; Janssens, L; Lasseter, KC; Lau, H; Verhaeghe, T; Zhao, Q, 2002)	0.31
"This study demonstrated that the bioavailability of risperidone was increased by verapamil, suggesting in vivo involvement of P-glycoprotein in the pharmacokinetics of risperidone."	( Effect of verapamil on pharmacokinetics and pharmacodynamics of risperidone: in vivo evidence of involvement of P-glycoprotein in risperidone disposition. Kaneo, S; Nakagami, T; Saito, M; Tateishi, T; Yasui-Furukori, N, 2005)	0.33
" The oral bioavailability of the polymer was 40%."	( Intestinal uptake and biodistribution of novel polymeric micelles after oral administration. Ariën, A; Brewster, M; Mathot, F; Préat, V; van Beijsterveldt, L, 2006)	0.33
"The objective of the study was to compare the bioavailability of a generic oral solution of risperidone (Test formulation) and Risperdal tablets (Reference formulation)."	( Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets. Piniella, PM; Relleke, M; van Os, S, 2007)	0.34
" Thus, rifampin reduced the exposure to risperidone, probably because of a decrease in its bioavailability through the induction of CYP3A and probably P-glycoprotein."	( Effect of rifampin, an inducer of CYP3A and P-glycoprotein, on the pharmacokinetics of risperidone. Kim, KA; Kim, KB; Lee, HJ; Liu, KH; Park, JY; Park, PW; Shin, JG, 2008)	0.35
" Interindividual variability (IIV) in clearance (CL), central volume of distribution (V(d)) and the absorption rate constant (k(a)) were estimated at a 40%, 69% and 59% coefficient of variation (CV), respectively."	( Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Samtani, MN; Stuyckens, K; Vermeulen, A, 2009)	0.61
" Paliperidone was well absorbed (median t(max): 24 h after a 3-mg dose, and 26 h after a 9-mg dose)."	( Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects. Guo, C; Liu, Y; Shu, L; Si, T; Su, YA; Zhang, H, 2010)	0.36
"The aims of this study were to compare the relative bioavailability of a pharmaceutical-equivalent (test) formulation with a reference formulation of oral RSP 2 mg, both available commercially on the Brazilian pharmaceutical market, and to generate data regarding the oral bioavailability of the tested drug in healthy Brazilian volunteers."	( Relative bioavailability of two oral formulations of risperidone 2 mg: A single-dose, randomized-sequence, open-label, two-period crossover comparison in healthy Brazilian volunteers. Belotto, KC; Ferreira, AS; Gattaz, WF; Raposo, NR, 2010)	0.36
" There was significant difference in the absorption rate constant (k ( a )) of risperidone among the CYP2D6*10 genotype groups."	( Population pharmacokinetic analysis of risperidone and 9-hydroxyrisperidone with genetic polymorphisms of CYP2D6 and ABCB1. Cho, HY; Lee, SN; Lee, YB; Yoo, HD; Yoon, H, 2012)	0.38
" The repeated exposures of silymarin, compared to single administration of silymarin, increased oral bioavailability and affected the pharmacokinetics of risperidone and 9-hydroxyrisperidone, by inhibiting P-gp."	( Effects of single or repeated silymarin administration on pharmacokinetics of risperidone and its major metabolite, 9-hydroxyrisperidone in rats. Chae, SW; Choi, JM; Lee, HJ; Lee, KS; Park, JH; Rhie, SJ, 2013)	0.39
" Currently, the literature on this topic is sparse, but the published pharmacokinetic studies and Food and Drug Administration submission data on paliperidone palmitate show discrepancies in the elimination half-life, peak plasma concentration, and absorption rate that are dependent on the site of injection."	( Paliperidone Palmitate Long-Acting Injectable Given Intramuscularly in the Deltoid Versus the Gluteal Muscle: Are They Therapeutically Equivalent? Barr, AM; Collier, AC; Honer, WG; Procyshyn, RM; Yin, J, 2015)	2.06
" Relative bioavailability in comparison with paliperidone was ∼100% independent of the dose and injection site."	( Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: A phase-1, single-dose, randomized, open-label study. Chang, CT; De Meulder, M; Gopal, S; Hough, D; Nuamah, I; Ravenstijn, P; Remmerie, B; Samtani, MN; Savitz, A, 2016)	0.69
" The oral bioavailability of paliperidone was increased by an estimated 51% (Cmax ) and 51%-52% (AUCs) when coadministered with divalproex sodium ER."	( Drug-Drug Interaction Studies of Paliperidone and Divalproex Sodium Extended-Release Tablets in Healthy Participants and Patients with Psychiatric Disorders. Ariyawansa, J; Berwaerts, J; Coppola, D; De Meulder, M; Remmerie, B, 2016)	0.43
" In Canada, no LAI product-specific bioequivalence guidance exists for multiphasic medication delivery systems, and the recently revised Comparative Bioavailability Standards: Formulations Used for Systemic Effects guidance applies only to oral and non-injectable formulations."	( Need for Bioequivalence Standards that Reflect the Clinical Importance of the Complex Pharmacokinetics of Paliperidone Palmitate Long-Acting Injectable Suspension. Katzman, MA; Lamoure, JW; Procyshyn, RM; Sherman, SE; Skinner, PL, 2019)	0.73
" The rate of removal of LAIs is regulated by the slow rate of absorption in the site of injection and the phenomenon of their increased half-life is called flip-flop pharmacokinetics."	( [Clinical pharmacokinetics and pharmaceutical forms of long-acting injectable antipsychotics]. Kyziridis, TC, 2022)	0.72
"46-fold improvement in the relative bioavailability in the brain for PPD-LNC compared to a drug suspension."	( Unraveling enhanced brain delivery of paliperidone-loaded lipid nanoconstructs: pharmacokinetic, behavioral, biochemical, and histological aspects. Ali, J; Ansari, MJ; Baboota, S; Iqubal, A; Javed, A; Khan, T; Nabi, B; Rehman, S, 2022)	0.72

Excerpt	Relevance	Reference
" Thirty healthy subjects received a 1 mg oral dose of risperidone before and after venlafaxine dosing to steady state."	( Effect of venlafaxine on the pharmacokinetics of risperidone. Albano, D; Amchin, J; Klockowski, PM; Taylor, KP; Zarycranski, W, 1999)	0.3
" Adding risperidone to mirtazapine probably does not necessitate a change of the dosage of either drug, but more extensive investigations are needed."	( Lack of drug interactions between mirtazapine and risperidone in psychiatric patients: a pilot study. Doorschot, CH; Loonen, AJ; Oostelbos, MC; Sitsen, JM, 1999)	0.3
"The optimal risperidone dosing strategy for acute schizophrenia requires elucidation."	( Risperidone in acutely exacerbated schizophrenia: dosing strategies and plasma levels. Chang, WH; Chiu, WC; Chou, JC; Lane, HY; Su, MH; Wu, ST, 2000)	0.31
"Evaluation of relationships between serum antipsychotic drug concentrations and clinical response may provide valuable information for rational dosage adjustments."	( Relationship between plasma risperidone and 9-hydroxyrisperidone concentrations and clinical response in patients with schizophrenia. Ancione, M; Avenoso, A; Facciolà, G; Madia, AG; Perucca, E; Salemi, M; Scordo, MG; Spina, E, 2001)	0.31
" The design of the study was open and risperidone dosage could be adjusted individually according to clinical response."	( Relationship between plasma risperidone and 9-hydroxyrisperidone concentrations and clinical response in patients with schizophrenia. Ancione, M; Avenoso, A; Facciolà, G; Madia, AG; Perucca, E; Salemi, M; Scordo, MG; Spina, E, 2001)	0.31
"We investigated the relationships between extrapyramidal symptoms (EPS) induced by risperidone, the dosage of risperidone and the combined plasma concentrations of risperidone plus its active metabolite, 9-hydroxyrisperidone, in 20 schizophrenic patients."	( Possible relationship between combined plasma concentrations of risperidone plus 9-hydroxyrisperidone and extrapyramidal symptoms. Preliminary study. Nakamura, J; Ueda, N; Yoshimura, R, 2001)	0.31
" Twenty geriatric inpatients were evaluated in a naturalistic setting with regard to total daily risperidone dose and dosing interval."	( Risperidone and 9-hydroxyrisperidone concentrations are not dependent on age or creatinine clearance among elderly subjects. Kastango, KB; Kirshner, MA; Maxwell, RA; Mulsant, BH; Pollock, BG; Rosen, J; Sweet, RA, 2002)	0.31
" Since the estimated risk of the extrapyramidal side effects varied with the dose, the present method of predicting the extrapyramidal side effects of risperidone may provide a basis for developing a rational dosing regimen for the drug."	( Prediction and assessment of extrapyramidal side effects induced by risperidone based on dopamine D(2) receptor occupancy. Fukuda, M; Iga, T; Nakashima, Y; Ohno, Y; Sato, H; Sawada, Y; Takayanagi, R; Tsuchiya, F; Yamada, Y, 2002)	0.31
" This may provide valuable information for rational dosage titration."	( Correlation between scores on Continuous Performance Test and plasma concentration for schizophrenic patients on risperidone. Chang, JW; Chen, PS; Liao, YC; Su, SF; Yang, YK; Yeh, TL, 2004)	0.32
" Larger studies regarding the PK/PD relationship may be required to develop a reasonable clinical dosage regimen for Chinese female patients."	( Multiple dose pharmacokinetics of risperidone and 9-hydroxyrisperidone in Chinese female patients with schizophrenia. Deng, CY; Li, HD; Li, WB; Li, X; Lin, QX; Lin, SG; Peng, HY; Su, FL; Wang, CY; Wang, F; Yang, M; Yu, XY; Zhou, ZL; Zhu, RH, 2006)	0.33
" Data were obtained from 407 patients enrolled in four Phase 1 (serial blood sampling) and three Phase 3 trials (sparse sampling), representing dosage regimens ranging from 4 mg single dose to flexible 1-6 mg once daily."	( Population pharmacokinetics of risperidone and 9-hydroxyrisperidone in patients with acute episodes associated with bipolar I disorder. Ludwig, EA; Piotrovsky, V; Vermeulen, A, 2007)	0.34
" In this randomized, double-blind, placebo-controlled, multicenter study, patients' symptoms were stabilized during an 8-week run-in and a 6-week stabilization phases using open-label, flexibly dosed paliperidone ER (3-15 mg once daily, starting dose = 9 mg)."	( Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Eerdekens, M; Kramer, M; Kushner, S; Lim, P; Maciulis, V; Simpson, G; Vijapurkar, U, 2007)	0.34
" It has been formulated in an osmotic controlled-release oral delivery system that minimizes peak-trough fluctuations and, by obviating dose-titration, allows once-daily dosing with a therapeutically active dose from the first day."	( Extended-release paliperidone: efficacy, safety and tolerability profile of a new atypical antipsychotic. Owen, RT, 2007)	0.34
" Both formulations contained 1 mg risperidone per dosing unit."	( Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets. Piniella, PM; Relleke, M; van Os, S, 2007)	0.34
" It has a unique extended-release delivery system, allowing once/day dosing with steady plasma concentrations of the medication."	( Paliperidone: a new extended-release oral atypical antipsychotic. Dlugosz, H; Nasrallah, HA, 2007)	0.34
" Paliperidone's advanced-generation osmotic release delivery system allows for the avoidance of dosage adjustment when initiating therapy and may decrease the frequency of antido-paminergic effects that would occur with an immediate-release formulation."	( Paliperidone for schizophrenia. Deyo, Z; Dolder, C; Nelson, M, 2008)	0.35
"To evaluate the efficacy and safety of an extended-release (ER) formulation of paliperidone in patients with an acute episode of schizophrenia, in the dosage range of 3 to 15 mg daily."	( Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. Bobo, WV; Eerdekens, M; Hough, D; Kramer, M; Lane, R; Meltzer, HY; Nuamah, IF, 2008)	0.35
" Paliperidone ER appears to be well tolerated at the recommended starting dosage of 6 mg/day."	( Paliperidone extended-release for the treatment of schizophrenia. Caballero, J; Marino, J, 2008)	0.35
" This finding has important implications for dosing of antipsychotics in older patients with schizophrenia."	( Sensitivity of older patients to antipsychotic motor side effects: a PET study examining potential mechanisms. Graff-Guerrero, A; Kapur, S; Mamo, DC; Mulsant, BH; Pollock, BG; Uchida, H, 2009)	0.35
" Following oral dosing of antipsychotics, peaks and troughs in plasma drug concentrations may be mirrored by fluctuations in D(2)-receptor occupancy."	( A comparison of continuous subcutaneous paliperidone infusion and repeated subcutaneous injection of risperidone free-base in rats. Casu, G; Deriu, A; Lazzari, P; Marchese, G; Pani, L; Peddio, G; Pira, M; Pisu, C; Pittau, B; Portesani, F; Spada, GP, 2010)	0.36
" The controlled rate of release of paliperidone from the ER formulation is designed to have a slower absorption rate, which results in gradual ascending plasma concentrations with observed maximum plasma concentrations occurring at 24 hours after dosing on the first dosing day."	( Single- and multiple-dose pharmacokinetics and dose proportionality of the psychotropic agent paliperidone extended release. Boom, S; Cleton, A; De Meulder, M; Eerdekens, M; Janssens, L; Remmerie, B; Rossenu, S; Talluri, K; van Osselaer, N, 2009)	0.35
" Dosage adjustments of paliperidone are not required in subjects with mild or moderate hepatic impairment."	( The influence of hepatic impairment on the pharmacokinetics of paliperidone. Boom, S; Cleton, A; Crauwels, H; Eerdekens, M; Janssens, L; Molz, KH; Talluri, K; Thyssen, A, 2009)	0.35
" It offers several advantages over other available second-generation depot antipsychotics: it comes in prefilled syringes in a number of different dosage strengths; it does not require refrigeration; it does not require supplementation with oral antipsychotics; it can be administered once monthly; it can be administered with a very small bore needle; the injection volume is small; the injection site can be either the deltoid or gluteal muscles; it does not require an additional precautionary observation period after the injection."	( Paliperidone palmitate - review of the efficacy, safety and cost of a new second-generation depot antipsychotic medication. Citrome, L, 2010)	1.8
"This article overviews the recommended dosing strategies for the treatment of schizophrenia patients using the recently FDA-approved once-monthly long-acting injectable atypical antipsychotic, paliperidone palmitate."	( Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. Alphs, L; Gassmann-Mayer, C; Gopal, S; Palumbo, J; Samtani, MN; Shiwach, R, 2010)	0.81
"Using pharmacokinetic (PK), efficacy and safety data from clinical trials and a comprehensive population PK simulation model, dosing recommendations for paliperidone palmitate have been generated."	( Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. Alphs, L; Gassmann-Mayer, C; Gopal, S; Palumbo, J; Samtani, MN; Shiwach, R, 2010)	0.82
" In patients with mild renal impairment (creatinine clearance [CrCL]: 50-80 mL/min), dosage should be adjusted."	( Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia. Alphs, L; Gassmann-Mayer, C; Gopal, S; Palumbo, J; Samtani, MN; Shiwach, R, 2010)	0.62
" The entrance prescription has been with paliperidone ER in a dosage of 6mg once a day."	( [Treatment with paliperidone extended-release tablets in a case of resistant undifferentiated schizophrenia: clinical improvement with 12 mg and evaluation through 3TRE scale]. Carlone, C; Muscillo, M; Piccione, M; Rusconi, AC, )	0.13
" However, these data were utilized to optimize the intramuscular paliperidone palmitate dosage regimen."	( Intramuscular paliperidone palmitate. Hoy, SM; Keating, GM; Scott, LJ, 2010)	0.96
"This study assessed the efficacy and the safety of a dosing regimen that was revised from earlier studies for the investigational injectable atypical antipsychotic paliperidone palmitate (approved in the USA, August 2009) for adult patients with acutely exacerbated schizophrenia."	( A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. Gopal, S; Herben, V; Kusumakar, V; Lim, P; Lindenmayer, JP; Lull, J; Palumbo, J; Pandina, GJ; Yuen, E, 2010)	0.78
" Patients [n = 493; Young Mania Rating Scale (YMRS) score >or= 20] were randomized (2:2:1) to flexibly dosed paliperidone ER (3-12 mg/day), quetiapine (400-800 mg/day), or placebo for the acute treatment phase."	( A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder. Berwaerts, J; Hough, DW; Lim, P; Nuamah, IF; Palumbo, JM; Vieta, E; Yuen, EC, 2010)	0.36
"In the male patients, there was no correlation between the RIS dosage and plasma PRL levels, between plasma RIS levels and PRL levels, or between the plasma 9-OH-RIS levels and PRL levels."	( Gender differences in the relationship between the risperidone metabolism and the plasma prolactin levels in psychiatric patients. Fukui, N; Inoue, Y; Ono, S; Someya, T; Sugai, T; Suzuki, Y; Tsuneyama, N; Watanabe, J, 2010)	0.36
" Subjects were randomized to 6 mg/d paliperidone ER or placebo with flexible dosing (3-12 mg/d) until day 15."	( Paliperidone extended-release in schizoaffective disorder: a randomized, controlled study comparing a flexible dose with placebo in patients treated with and without antidepressants and/or mood stabilizers. Bossie, CA; Canuso, CM; Carothers, J; Kosik-Gonzalez, C; Lindenmayer, JP; Schooler, N; Turkoz, I; Walling, D, 2010)	0.36
"), and once-monthly flexible dosing as deltoid or gluteal injections on day 36 (50 mg eq."	( A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Gassmann-Mayer, C; Gopal, S; Hough, D; Lane, R; Pandina, G; Remmerie, B; Simpson, G, 2011)	0.68
" The dosage range of paliperidone ER (6-12 mg/day) was compared with 2 risperidone dosage ranges: 2-4 and 4-6 mg/day."	( Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis. Bossie, CA; Canuso, CM; Lindenmayer, JP; Schooler, N; Turkoz, I, 2011)	0.37
"]; then once-monthly deltoid or gluteal injections, flexibly dosed [50, 100, or 150 mg eq."	( A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. Gu, N; Li, H; Ning, X; Rui, Q; Xu, H, 2011)	0.68
"This study aimed to explore the relationship between dosage of paliperidone and drug attitude, and also clarify the factors associated with drug attitude, using Intention-to-Treat (ITT) analysis."	( Social interaction and drug attitude effectiveness in patients with schizophrenia. Lin, WK; Lung, FW; Tsai, JK, 2011)	0.37
" The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular (deltoid) injection; followed by 39 to 234 mg once-monthly thereafter (deltoid or gluteal)."	( Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. Alphs, L; Bossie, CA; Fu, DJ; Ma, YW; Sliwa, JK, 2011)	0.59
" on days 1 and 8, and flexible dosing [25-100 mg eq."	( A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Eerdekens, M; Fleischhacker, WW; Gassmann-Mayer, C; Gopal, S; Hough, D; Lane, R; Lim, P; Remmerie, B, 2012)	0.69
" Weight-based dosing of paliperidone ER in adolescents with schizophrenia does not appear to be necessary."	( A randomized, double-blind study of paliperidone extended-release in treatment of acute schizophrenia in adolescents. Hough, D; Nuamah, I; Robb, A; Singh, J; Vijapurkar, U, 2011)	0.37
" This article reviews the recommended dosing regimens for initiation and maintenance treatment with paliperidone palmitate in adult patients with schizophrenia."	( Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data. Alphs, L; Gassmann-Mayer, C; Gopal, S; Palumbo, JM; Samtani, MN, 2011)	0.86
"There was no correlation between risperidone dosage and QTc or plasma risperidone levels and QTc."	( QT prolongation of the antipsychotic risperidone is predominantly related to its 9-hydroxy metabolite paliperidone. Fukui, N; Inoue, Y; Ono, S; Saito, M; Someya, T; Sugai, T; Suzuki, Y; Tsuneyama, N; Watanabe, J, 2012)	0.38
"We aimed to explore relations between symptomatic remission and functionality evaluation in schizophrenia patients treated with paliperidone extended-release (ER), as seen in a normal day-to-day practice, using flexible dosing regimens of paliperidone ER."	( Effects of paliperidone extended release on the symptoms and functioning of schizophrenia. Chan, CH; Cheng, KS; Chiu, WC; Huang, MW; Lan, TH; Li, CY; Liu, IC; Su, PW; Ten, PR; Wu, BJ; Yang, TT; Yeh, YC, 2012)	0.38
" Flexible dosing in the range 3-12 mg/day was used throughout the study."	( Effects of paliperidone extended release on the symptoms and functioning of schizophrenia. Chan, CH; Cheng, KS; Chiu, WC; Huang, MW; Lan, TH; Li, CY; Liu, IC; Su, PW; Ten, PR; Wu, BJ; Yang, TT; Yeh, YC, 2012)	0.38
"Due to high interindividual variability in peripheral pharmacokinetic parameters, dosing of antipsychotics relies on clinical trial and error."	( Predicting plasma concentration of risperidone associated with dosage change: a population pharmacokinetic study. Bies, RR; Mamo, DC; Mimura, M; Pollock, BG; Suzuki, T; Tsunoda, K; Uchida, H; Watanabe, K, 2012)	0.38
" In light of the known relationship between plasma drug concentration, dopamine D2 receptor occupancy, and clinical effects, our results confirm that individualized dosing with the measurement of antipsychotic plasma concentrations has the potential for bedside clinical application."	( Predicting plasma concentration of risperidone associated with dosage change: a population pharmacokinetic study. Bies, RR; Mamo, DC; Mimura, M; Pollock, BG; Suzuki, T; Tsunoda, K; Uchida, H; Watanabe, K, 2012)	0.38
" The dosing initiation regimen resulted in rapidly achieved and maintained therapeutic paliperidone levels over the study (average concentrations during the dosing interval were 34."	( A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia. Coppola, D; Gopal, S; Hough, DW; Liu, Y; Nuamah, I; Pandina, G; Remmerie, B; Samtani, MN; Sulaiman, A, 2012)	0.59
" Multiple linear regression analysis (95 samples) revealed that sex, smoking habit, and dose explained 21% of the variation in plasma total risperidone after oral dosage (dose alone only explained 11% of the variation)."	( Risperidone and total 9-hydroxyrisperidone in relation to prescribed dose and other factors: data from a therapeutic drug monitoring service, 2002-2010. Bowskill, SV; Fisher, DS; Flanagan, RJ; Handley, SA; Patel, MX, 2012)	0.38
"Risperidone therapeutic drug monitoring can help assess adherence and guide dosage even after RLAI."	( Risperidone and total 9-hydroxyrisperidone in relation to prescribed dose and other factors: data from a therapeutic drug monitoring service, 2002-2010. Bowskill, SV; Fisher, DS; Flanagan, RJ; Handley, SA; Patel, MX, 2012)	0.38
" In two 13-week trials, one of which was conducted in Chinese patients, intramuscular paliperidone palmitate administered using the recommended initiation dosage regimen was noninferior to LAI-risperidone in patients with schizophrenia in terms of the between-group treatment difference (intramuscular paliperidone palmitate vs LAI-risperidone) for the mean change from baseline to endpoint in PANSS total score."	( Extended-release intramuscular paliperidone palmitate: a review of its use in the treatment of schizophrenia. Carter, NJ, 2012)	0.89
" Although paliperidone is the active metabolite of risperidone, paliperidone's route of metabolism and elimination is quite different from that for risperidone and paliperidone ER may be preferred over risperidone when liver disease, drug-drug interactions or other alterations in metabolism render the appropriate dosing of risperidone difficult to determine for an individual patient."	( Oral paliperidone extended-release: chemistry, pharmacodynamics, pharmacokinetics and metabolism, clinical efficacy, safety and tolerability. Citrome, L, 2012)	0.38
" When flexibly dosed with a mean doses of approximately 70 to 110 mg every four weeks, paliperidone palmitate appears comparable in efficacy and tolerability to risperidone long-acting injection flexibly dosed with mean doses of approximately 35 mg every two weeks."	( Paliperidone palmitate for schizophrenia. Nussbaum, AM; Stroup, TS, 2012)	2.04
" This model may aid the development of individualized risperidone dosing regimens in children and adolescents."	( Population pharmacokinetic modeling of risperidone and 9-hydroxyrisperidone to estimate CYP2D6 subpopulations in children and adolescents. Aman, MG; Bies, RR; Saldaña, SN; Sherwin, CM; Vinks, AA, 2012)	0.38
" This achieves therapeutic levels rapidly and simplifies dosing regimens, leading to potentially better adherence and improved outcome."	( The pharmacology and formulation of paliperidone extended release. Baker, GB; Chue, JA; Chue, PS; MacKenzie, EM, 2012)	0.38
" They responded well to the reduction in dosage or to withdrawal of the apparent causing agent."	( [Medication-related oculogyric crises: a description of four cases and a review of the literature]. Campistol, J; Darling, A; Perez-Duenas, B; Poo, P, 2013)	0.39
" If dosing recommendations for this population would have been based only on the results of the single efficacy trial included in this program, paliperidone dosing in adolescents might have been limited to 3 mg/d in adolescents less than 51 kg and to 6 mg/d in adolescents greater than or equal to 51 kg."	( An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia. Gobburu, JV; Laughren, TP; Mathis, M; Wang, Y; Younis, IR, 2013)	0.39
" Phase 1 (4 weeks) was a continuation of usual antipsychotic treatment (UAT); phase 2 (5 weeks) consisted of a 1-week cross-titration from UAT to flexibly dosed paliperidone ER (3-12 mg/d), followed by 4 weeks of paliperidone ER alone."	( Safety of paliperidone extended-release in patients with schizophrenia or schizoaffective disorder and hepatic disease. Alphs, L; Amatniek, J; Canuso, CM; Deutsch, SI; Henderson, DC; Mao, L; Mikesell, C; Rodriguez, S; Sheehan, J, 2014)	0.4
"The results of this study suggest that switching elderly patients from risperidone to PAL may result in superior safety and patient satisfaction, and may also make it possible to reduce the dosage of biperiden."	( Study of the efficacy and safety of switching from risperidone to paliperidone in elderly patients with schizophrenia. Gen, K; Hibino, H; Inoue, Y; Matsumoto, H; Mikami, A; Mikami, K; Otomo, M; Suzuki, H, 2013)	0.39
" Subjects received either: 1) paliperidone palmitate (PP; 234 mg day 1 and 156 mg day 8 [corresponding to 150 and 100 milligram equivalents of paliperidone, respectively], both administered in deltoid muscle, followed by once-monthly flexible dosing in deltoid or gluteal muscle) and risperidone long-acting injection (RLAI)-matched placebo injections; or, 2) RLAI (25 mg, days 8 and 22; followed by biweekly flexible dosing) and PP-matched placebo injections."	( Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Alphs, L; Bossie, CA; Fu, DJ; Kern Sliwa, J; Ma, YW, 2014)	2.13
"Using the recommended dosing regimens for PP and RLAI, both PP and oral risperidone (used during RLAI initiation) improved symptoms of schizophrenia in markedly-to-severely ill subjects at days 4-22."	( Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Alphs, L; Bossie, CA; Fu, DJ; Kern Sliwa, J; Ma, YW, 2014)	1.85
"Clinical pharmacology as an interdisciplinary science is unique in its capacity and the diversity of the methods and approaches it can provide to derive dosing recommendations in various subpopulations."	( An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: review of recent cases in psychiatry drugs. Mehta, MU; Rogers, H; Uppoor, RS; Younis, IR; Zhang, H; Zhu, H, 2013)	0.39
" A biweekly simulation of multiple dosing revealed that Formulation C, the selected formulation, with a high load and large particle size would provide adequate initial and maintenance levels of the active moiety (Risperidone and its metabolite, 9-hydroxyrisperidone)."	( Microsphere delivery of Risperidone as an alternative to combination therapy. D'Souza, S; DeLuca, P; Faraj, J, 2013)	0.39
" In the USA, dosing tends to be expressed in mg] or oral risperidone [during initiation of risperidone long-acting injection (RLAI) days 1-28] and biweekly flexible-dose RLAI (n=173; initial injection day 8)."	( Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Alphs, L; Bossie, CA; Fu, DJ; Ma, YW; Sliwa, JK, 2014)	1.85
"The purpose of this prospective study was to evaluate the effects of switching from oral risperidone to flexibly dosed oral paliperidone extended-release (ER) in Brazilian adults with schizophrenia because of lack of efficacy, intolerability, or nonadherence after a minimum trial of 30 days on adequate (labeled) doses of oral risperidone, according to individual clinical judgment."	( Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study. Appolinário, JC; Bressan, RA; Campos, JA; de Oliveira, IR; Elkis, H; Gattaz, WF; Grabowski, HM; Henna, E; Lacerda, AL; Lawson, FL; Louzã, MR; Périco, Cde A; Quevedo, J; Rocha, FL; Ruschel, SI; Sacomani, E; Zorzetto Filho, D, 2014)	0.4
"This study explores relevant outcomes with flexibly dosed paliperidone extended-release (ER) in a real-world design."	( Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics. Dilbaz, N; Franco, MA; Lahaye, M; Lara, E; Millet, B; Naber, D; Neznanov, NG; Peuskens, J; Rancans, E; Schreiner, A; Smeraldi, E; Turczynski, J, 2014)	0.4
" Analyses were performed assuming dosing of clinical trials, real-world practice, PIs, and highest therapeutic dose available, because of variation in practice settings."	( Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States. Baker, RA; Bentley, TG; Citrome, L; Eramo, A; Gutierrez, B; Hansen, K; Kamat, SA; Ortendahl, J; Sapin, C, 2014)	0.64
" When PI dosing was assumed, this ICER increased to US$19,968/relapse averted."	( Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States. Baker, RA; Bentley, TG; Citrome, L; Eramo, A; Gutierrez, B; Hansen, K; Kamat, SA; Ortendahl, J; Sapin, C, 2014)	0.64
" Under various dosing scenarios, AOM results indicated fewer relapses at lower overall costs or a reasonable cost-effectiveness threshold (i."	( Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States. Baker, RA; Bentley, TG; Citrome, L; Eramo, A; Gutierrez, B; Hansen, K; Kamat, SA; Ortendahl, J; Sapin, C, 2014)	0.64
"The goal of this study was to explore the tolerability, safety, and treatment response of flexible doses of once-monthly paliperidone palmitate (PP) in the subset of nonacute but symptomatic adult patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents in the PALMFlexS (Paliperidone Palmitate Flexible Dosing in Schizophrenia) study."	( A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Bergmans, P; Bez, Y; Carpiniello, B; Cherubin, P; Hargarter, L; Keim, S; Parellada, E; Rancans, E; Schreiner, A; Vidailhet, P, 2014)	0.88
" They also demonstrate that a clinically relevant treatment response is possible in patients who are considered to be clinically stable by their physician, supporting the use of flexibly dosed PP in such patients."	( A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Bergmans, P; Bez, Y; Carpiniello, B; Cherubin, P; Hargarter, L; Keim, S; Parellada, E; Rancans, E; Schreiner, A; Vidailhet, P, 2014)	0.68
"In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics."	( Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics. Bergmans, P; Bez, Y; Carpiniello, B; Cherubin, P; Hargarter, L; Keim, S; Parellada, E; Rancans, E; Schreiner, A; Vidailhet, P, 2015)	0.96
"In this multicenter, double-blind, phase 3 study (screening [≤3 weeks], with an acute treatment period [8 weeks] and a maintenance period [18 weeks]), adolescents (12-17 years old) with schizophrenia (DSM-IV diagnosis; Positive and Negative Symptom Score [PANSS] total score 60-120) were randomized (1:1) to once-daily paliperidone ER (6 mg per day [days 1-7], flexibly dosed 3, 6, or 9 mg per day from week 2 to end of study [EOS]), or to aripiprazole (2 mg per day [days 1 and 2], 5 mg per day [days 3 and 4], 10 mg per day [days 5-7], flexibly dosed 5, 10, or 15 mg per day [week 2 to EOS])."	( Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study. Gopal, S; Hough, D; Lane, R; Nuamah, I; Savitz, AJ, 2015)	0.42
"PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs)."	( Paliperidone palmitate in non-acute patients with schizophrenia previously unsuccessfully treated with risperidone long-acting therapy or frequently used conventional depot antipsychotics. Bergmans, P; Cherubin, P; Corrivetti, G; Cosar, B; Hargarter, L; Keim, S; Llorca, PM; Petralia, A; Schreiner, A, 2015)	2.04
" Thus, using the same maintenance dosing regimen at both sites or switching between sites of injection may result in unforeseen consequences in patient outcomes."	( Paliperidone Palmitate Long-Acting Injectable Given Intramuscularly in the Deltoid Versus the Gluteal Muscle: Are They Therapeutically Equivalent? Barr, AM; Collier, AC; Honer, WG; Procyshyn, RM; Yin, J, 2015)	1.86
" These results highlight the importance of a personalized dosage adjustment during risperidone treatment."	( Genetics-Based Population Pharmacokinetics and Pharmacodynamics of Risperidone in a Psychiatric Cohort. Choong, E; Conus, P; Csajka, C; Eap, CB; Guidi, M; Vandenberghe, F; von Gunten, A, 2015)	0.42
" Results support a once-every-3-months dosing interval in patients with schizophrenia or schizoaffective disorder."	( Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: A phase-1, single-dose, randomized, open-label study. Chang, CT; De Meulder, M; Gopal, S; Hough, D; Nuamah, I; Ravenstijn, P; Remmerie, B; Samtani, MN; Savitz, A, 2016)	0.69
"Population pharmacokinetics can predict antipsychotic blood concentrations at a given time point prior to a dosage change."	( Dopamine D2/3 Receptor Occupancy Following Dose Reduction Is Predictable With Minimal Plasma Antipsychotic Concentrations: An Open-Label Clinical Trial. Bies, RR; Caravaggio, F; Gerretsen, P; Graff-Guerrero, A; Mamo, DC; Mar, W; Mulsant, BH; Nakajima, S; Plitman, E; Pollock, BG; Suzuki, T; Uchida, H, 2016)	0.43
"D2/3R occupancy levels can be predicted from blood drug concentrations collected prior to dosage change."	( Dopamine D2/3 Receptor Occupancy Following Dose Reduction Is Predictable With Minimal Plasma Antipsychotic Concentrations: An Open-Label Clinical Trial. Bies, RR; Caravaggio, F; Gerretsen, P; Graff-Guerrero, A; Mamo, DC; Mar, W; Mulsant, BH; Nakajima, S; Plitman, E; Pollock, BG; Suzuki, T; Uchida, H, 2016)	0.43
"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."	( Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Berwaerts, J; Buron Vidal, JA; Gopal, S; Hough, D; Nandy, P; Nuamah, I; Ravenstijn, P; Samtani, MN; Savitz, A; Vermeulen, A, 2015)	0.87
"Recommendations for different dosing scenarios are based on the pharmacokinetic, efficacy and safety outcomes from phase 1 and phase 3 studies, population pharmacokinetic models, and model based simulations."	( Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Berwaerts, J; Buron Vidal, JA; Gopal, S; Hough, D; Nandy, P; Nuamah, I; Ravenstijn, P; Samtani, MN; Savitz, A; Vermeulen, A, 2015)	0.67
"), with a dosing window of ± 1 week."	( Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Berwaerts, J; Buron Vidal, JA; Gopal, S; Hough, D; Nandy, P; Nuamah, I; Ravenstijn, P; Samtani, MN; Savitz, A; Vermeulen, A, 2015)	0.67
" The efficacy and tolerability of paliperidone palmitate one-month (PP1M) in Chinese patients switched from previous antipsychotic treatments were examined in order to develop effective switching and dosing strategies."	( A Subgroup Analysis of Chinese Patients Switched to Paliperidone Palmitate One-Month Injectable by Prior Oral Antipsychotic Treatment. Fan, J; Feng, Y; Si, T; Wang, C; Wang, X; Xu, C; Zhuo, J, 2016)	0.96
" Analyses were conducted assuming pooled dosing from randomised clinical trials included in the MTCs."	( Cost-effectiveness Analysis of Aripiprazole Once-Monthly for the Treatment of Schizophrenia in the UK. Beillat, M; Robinson, P; Sapin, C; Tempest, M; Treur, M, 2015)	0.42
" The treatment response was described using a drug-disease model accounting for multiple components such as the dosage regimen, the pharmacokinetic characteristics of a drug (including the mechanism and the rate of drug delivery), and the exposure-response relationship."	( Response Surface Analysis and Nonlinear Optimization Algorithm for Maximization of Clinical Drug Performance: Application to Extended-Release and Long-Acting Injectable Paliperidone. Bressolle-Gomeni, F; Fava, M; Gomeni, R, 2016)	0.43
"Taken together, PP3M with its 3-month dosing interval is a unique option for relapse prevention in schizophrenia."	( Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study. Fleischhacker, WW; Gopal, S; Hough, D; Janik, A; Nuamah, I; Ravenstijn, P; Savitz, AJ; Schotte, A; Xu, H, 2016)	0.74
" The dosage of risperidone and paliperidone were maintained; and aripiprazole was maintained at 5mg/day during the 8-week study period."	( Add-on effects of a low-dose aripiprazole in resolving hyperprolactinemia induced by risperidone or paliperidone. Guo, Q; Li, C; Ouyang, Q; Qiao, Y; Shen, W; Sheng, J; Wen, H; Yang, F; Zhu, S, 2016)	0.43
" Semi-quantitative histopathology of the IM administration sites at day 1, 3, 7, 14, 21 and 28 after dosing with PP-LAI illustrated that CLO significantly decreased the rate and extent of the granulomatous inflammatory reaction."	( The effect of macrophage and angiogenesis inhibition on the drug release and absorption from an intramuscular sustained-release paliperidone palmitate suspension. Annaert, P; Darville, N; De Jonghe, S; De Meulder, M; Mariën, D; Rossenu, S; Sterkens, P; Van den Mooter, G; van Heerden, M; Vermeulen, A; Vynckier, A, 2016)	0.64
" 3MPP offers a substantially longer dosing interval than other options, which may be a potential advancement to reduce nonadherence."	( Three-month paliperidone palmitate - a new treatment option for schizophrenia. Bernardo, M; Bioque, M, 2016)	0.81
"The median daily dosage of RIS did not differ between the groups (p=0."	( Pharmacokinetic considerations in the treatment of hypertension in risperidone-medicated patients - thinking of clinically relevant CYP2D6 interactions. Gründer, G; Haen, E; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Schruers, KR; Stegmann, B; Walther, S, 2016)	0.43
" Higher RIS dosage has a tendency to produce higher RIS plasma levels."	( Development and Validation of Liquid Chromatography/Tandem Mass Spectrometry Analysis for Therapeutic Drug Monitoring of Risperidone and 9-Hydroxyrisperidone in Pediatric Patients with Autism Spectrum Disorders. Hongkaew, Y; Limsila, P; Nakorn, CN; Ngamsamut, N; Nuntamool, N; Prommas, S; Puangpetch, A; Sukasem, C; Vanwong, N, 2016)	0.43
" This open-label, parallel-group study was performed to compare finger-stick-based capillary with corresponding venous plasma concentrations for risperidone, paliperidone, quetiapine, olanzapine, and aripiprazole and their major metabolites after repeated dosing in patients with schizophrenia or related illnesses."	( Comparison of Capillary and Venous Plasma Drug Concentrations After Repeated Administration of Risperidone, Paliperidone, Quetiapine, Olanzapine, or Aripiprazole. Ariyawansa, J; De Meulder, M; Remmerie, B; Savitz, A, 2016)	0.43
" It is a convenient alternative to the commercially available dosage form of PPD."	( Paliperidone-Loaded Nanolipomer System for Sustained Delivery and Enhanced Intestinal Permeation: Superiority to Polymeric and Solid Lipid Nanoparticles. Helal, HM; Mortada, SM; Sallam, MA, 2017)	0.46
"Daily dosage of risperidone differed significantly with smokers receiving higher doses than patients in the control group (p=0."	( Effect of smoking on risperidone pharmacokinetics - A multifactorial approach to better predict the influence on drug metabolism. Gründer, G; Haen, E; Hiemke, C; Paulzen, M; Schoretsanitis, G; Stegmann, B, 2017)	0.46
"Three-month long-acting paliperidone is a new, recently marketed, formulation of paliperidone, characterised by the longest available dosing interval among long-acting antipsychotics."	( New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base. Barbui, C; Gastaldon, C; Ostuzzi, G; Papola, D, 2017)	0.46
" UKU, Clinical Global Impression-Severity (CGI-S), Personal and Social Performance (PSP) and dosage of paliperidone were collected."	( Reliability and Validity of the Short Version of Udvalg for Kliniske Undersogelser in Antipsychotic Treatment. Chen, KP; Lung, FW, 2017)	0.46
" Groups were matched for demographic characteristics and daily dosage of RIS."	( Cytochrome P450-mediated interaction between perazine and risperidone: implications for antipsychotic polypharmacy. Gründer, G; Haen, E; Hiemke, C; Lammertz, SE; Paulzen, M; Schoretsanitis, G; Stegmann, B, 2017)	0.46
" This article reviews the pharmacokinetic rationale for the approved dosing regimens for PP3M, dosing windows, management of missed doses and treatment discontinuation, switching to other formulations, and dosing in special populations."	( Dosing and Switching Strategies for Paliperidone Palmitate 3-Month Formulation in Patients with Schizophrenia Based on Population Pharmacokinetic Modeling and Simulation, and Clinical Trial Data. Jonsson, EN; Magnusson, MO; Plan, EL; Rossenu, S; Russu, A; Samtani, MN; Vermeulen, A, 2017)	0.73
" Following patients were given a dosage ranging from 50 mg to 150 mg every 28 days."	( Paliperidone Long-Acting Plasma Level Monitoring and a New Method of Evaluation of Clinical Stability. Altamura, CA; Di Pace, C; Fiorentini, A; Mauri, MC; Paletta, S; Reggiori, A; Rovera, C, 2017)	0.46
"Second-generation long-acting injectable therapies (SGA-LAIs) may reduce health care resource utilization (HRU) and health care costs compared with daily oral atypical antipsychotics (OAAs) in patients with schizophrenia due to reduced dosing frequency, delivery/monitoring by a health care provider, and improved adherence."	( Treatment Patterns, Health Care Resource Utilization, and Spending in Medicaid Beneficiaries Initiating Second-generation Long-acting Injectable Agents Versus Oral Atypical Antipsychotics. Emond, B; Joshi, K; Kamstra, R; Lafeuille, MH; Lefebvre, P; Pilon, D; Tandon, N, 2017)	0.46
"We assessed the dosage strengths of paliperidone palmitate 1-month (PP1M) long-acting injectable resulting in similar steady-state (SS) exposures to the dosage strengths of oral risperidone using pharmacokinetic (PK) simulations."	( Maintenance dose conversion between oral risperidone and paliperidone palmitate 1 month: Practical guidance based on pharmacokinetic simulations. Gopal, S; Kern Sliwa, J; Kim, E; Mathews, M; Ravenstijn, P; Russu, A; Singh, A, 2018)	1
"This was a post-hoc analysis from an open-label, single-arm study of stable patients (Positive and Negative Syndrome Scale total score <70; n=367) receiving paliperidone palmitate one-month formulation at the end of an acute 13-week treatment phase, who entered a naturalistic one-year follow-up period, either continuing with flexibly dosed paliperidone palmitate one-month formulation (75-150 mg eq."	( Impact of paliperidone palmitate one-month formulation on relapse prevention in patients with schizophrenia: A post-hoc analysis of a one-year, open-label study stratified by medication adherence. Cai, S; Correll, CU; Feng, Y; Li, N; Lu, H; Si, T; Zhang, L; Zhuo, J, 2018)	1.08
" Reasons for prescribing were convenience of 3-monthly dosing for patients (94."	( Early Australian experience in the maintenance of schizophrenia management with 3-monthly paliperidone palmitate. Pai, N; Warden, M, 2018)	0.7
"Convenient 3-monthly dosing was preferred by clinicians and patients, and symptoms were adequately managed."	( Early Australian experience in the maintenance of schizophrenia management with 3-monthly paliperidone palmitate. Pai, N; Warden, M, 2018)	0.7
" Veterans were eligible for inclusion if they were aged 18years or older, had ≥1 dispensation of PP3M, were enrolled with VHA benefits for ≥24 months prior to transition to PP3M, had ≥1 schizophrenia diagnosis, were transitioned to PP3M according to prescribing-information guidelines (operationalized as no gap in PP1M treatment of >45days during the 4 months prior to PP3M transition, with the same dosage in the last 2 PP1M dispensations), and had appropriate dose conversion."	( Health Care Resource Utilization and Costs Associated with Transitioning to 3-month Paliperidone Palmitate Among US Veterans. Bhak, RH; Bobbili, P; Brown, B; DerSarkissian, M; El Khoury, AC; Hellstern, M; Joshi, K; Lafeuille, MH; Lefebvre, P; Shiner, B; Young-Xu, Y, 2018)	0.71
" Expert opinion: PP3M offers a substantially longer dosing interval than other options, which may be a potential advancement to reduce nonadherence in some patients."	( The current data on the 3-month paliperidone palmitate formulation for the treatment of schizophrenia. Bernardo, M; Bioque, M, 2018)	0.76
" Early TDM studies may help orient PP1M dosing but steady state may not be reached until after the ninth injection (8 months)."	( A systematic review and combined analysis of therapeutic drug monitoring studies for long-acting paliperidone. de Leon, J; Hiemke, C; Schoretsanitis, G; Spina, E, 2018)	0.48
" no gap of >45 days in PP1M coverage for ≥4 months, same PP1M dosage for the last two PP1M claims, and appropriate PP1M to PP3M dosing conversion) were selected from the IQVIA PharMetrics Plus database (May 2014-February 2018)."	( Real-world outcomes post-transition to once-every-3-months paliperidone palmitate in patients with schizophrenia within US commercial plans. El Khoury, AC; Emond, B; Joshi, K; Lefebvre, P; Morrison, L; Patel, C; Pilon, D; Tandon, N; Zhdanava, M, 2019)	0.76
" Hence, a different dosing strategy is required among smoking and nonsmoking patients."	( Analysis of smoking behavior on the pharmacokinetics of antidepressants and antipsychotics: evidence for the role of alternative pathways apart from CYP1A2. Deckert, J; Hommers, LG; Menke, A; Samanski, L; Scherf-Clavel, M; Unterecker, S, 2019)	0.51
" Paliperidone LAI (P-LAI), an atypical antipsychotic, has benefits over other antipsychotics LAI with its long dosing interval and no initial oral overlap, but has no documented cases for this indication."	( Paliperidone Long-Acting Injections in Huntington's Disease for Motor and Behavioural Disturbances. Theodoros, T; van Oosterom, N, 2019)	0.51
"Modeling dose-response relationships of drugs is essential to understanding their safety effects on patients under realistic circumstances."	( Bayesian Meta-analysis of Multiple Continuous Treatments with Individual Participant-Level Data: An Application to Antipsychotic Drugs. Horvitz-Lennon, M; Normand, ST; Spertus, J, 2019)	0.51
" The novel three-monthly paliperidone palmitate treatment (PP3M) offers the longest dosing interval currently available in France."	( The clinical and economic impact of three-monthly long-acting formulation of paliperidone palmitate versus the one-monthly formulation in the treatment of schizophrenia in France: A cost-utility study. Arteaga Duarte, CH; Fakra, E; Guillon, P; Van Gils, C, 2019)	1.05
"We report the case of a 7-year-old girl who was accidentally dosed with paliperidone for 3 days."	( Accidental Pediatric Paliperidone Ingestion Resulting in Delayed Profound Tachycardia. Borek, HA; Charlton, NP, 2019)	0.51
" Conversely, a delay in attaining therapeutic plasma concentrations of paliperidone on initiation of treatment, or a return to low plasma concentrations before the end of a dosing interval during repeated dosing, increases the risk of relapse."	( Need for Bioequivalence Standards that Reflect the Clinical Importance of the Complex Pharmacokinetics of Paliperidone Palmitate Long-Acting Injectable Suspension. Katzman, MA; Lamoure, JW; Procyshyn, RM; Sherman, SE; Skinner, PL, 2019)	0.73
"The dose-response relationships of antipsychotic drugs for schizophrenia are not well defined, but such information would be important for decision making by clinicians."	( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia. Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020)	0.56
" Dose-response curves were constructed with random-effects dose-response meta-analyses and a spline model."	( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia. Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020)	0.56
" For some drugs, higher than currently licensed doses might be tested in further trials, because their dose-response curves did not plateau."	( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia. Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020)	0.56
"Three-monthly dosage of paliperidone palmitate entails longer time to relapse after discontinuation, is similarly tolerable and safe compared to monthly injections of paliperidone palmitate and is beneficial for the caregivers."	( Patients' perspectives on three-monthly administration of antipsychotic treatment with paliperidone palmitate - a qualitative interview study. Erdner, A; Hedberg, B; Jedenius, E; Møllerhøj, J; Riise, J; Rise, MB; Stahl, K; Stølan, LO, 2021)	1.15
"Antipsychotics with reduced dosing frequency may improve adherence and clinical outcomes for patients with schizophrenia."	( Medication adherence, healthcare resource utilization, and costs among Medicaid beneficiaries with schizophrenia treated with once-monthly paliperidone palmitate or once-every-three-months paliperidone palmitate. Côté-Sergent, A; Joshi, K; Lafeuille, MH; Lefebvre, P; Lin, D; Pilon, D; Vermette-Laforme, M; Zhdanava, M, 2021)	0.82
" Particularly, older female patients (>50 years) are likely exposed to high concentration and cautious dosing in this subgroup is required."	( Impact of age and gender on paliperidone exposure in patients after administration of long-acting injectable formulations-an observational study using blood samples from 1223 patients. Haslemo, T; Høiseth, G; Molden, E; Smith, RL; Tveito, M, 2021)	0.62
"In this work, the versatility of pressure extrusion-based printing (PEBP) was used as 3D printing process to create long-acting implantable dosage forms."	( Long-acting implantable dosage forms containing paliperidone palmitate obtained by 3D printing. Benali, S; Deldime, M; Goole, J; Manini, G; Raquez, JM, 2021)	0.88
"The efficacy of a twice-yearly dosing regimen of PP6M was noninferior to that of PP3M in preventing relapse in patients with schizophrenia adequately treated with PP1M or PP3M."	( A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia. Cohen, K; Galderisi, S; Gopal, S; Lim, P; Milz, R; Najarian, D; Robertson, MJ; Sanga, P; Schotte, A; Singh, A; T'Jollyn, H; Venkatasubramanian, R; Walling, DP; Wang, S, 2022)	0.95
"PP3M is mostly prescribed in adherent patients with fairly stable schizophrenia, and the longer dosing interval does not substantially affect patient care."	( Initiation of quarterly palmitate paliperidone in French clinical practice: Results from the observational, cross-sectional OPTIMUS study. Bouju, S; Boursicot-Beuzelin, J; Déal, C; Fakra, E; Falissard, B; Gary, C; Giordana, JY; Samalin, L, 2022)	0.72
" A population pharmacokinetic (PPK) modeling and simulation approach was implemented to identify TV-46000 doses and dosing schedules for clinical development that would provide the best balance between clinical efficacy and safety."	( Population Pharmacokinetic Modeling and Simulation of TV-46000: A Long-Acting Injectable Formulation of Risperidone. Elgart, A; Gomeni, R; Harary, E; Kalmanczhelyi, A; Lamson, M; Levi, M; Loupe, P; Merenlender Wagner, A; Perlstein, I; Spiegelstein, O; Tiver, R, 2022)	0.72
"In the pharmaceutical field, there is a growing interest in manufacturing of drug delivery dosage forms adapted to the needs of a large variety of patients."	( Proof of concept of a predictive model of drug release from long-acting implants obtained by fused-deposition modeling. Benali, S; Goole, J; Manini, G; Raquez, JM, 2022)	0.72
"In this work, two technologies were used to prepare long-acting implantable dosage forms in the treatment of schizophrenia."	( Paliperidone palmitate as model of heat-sensitive drug for long-acting 3D printing application. Benali, S; Goole, J; Manini, G; Mathew, A; Napolitano, S; Raquez, JM, 2022)	2.16
" For 25 years, this author has focused on a circumscribed type of precision medicine: personalized dosing using pharmacokinetic mechanisms to stratified patients."	( Precision psychiatry: The complexity of personalizing antipsychotic dosing. de Leon, J, 2022)	0.72
" We also determine a range of products that are bioequivalent after both multiple dosing and single dosing."	( Determining bioequivalence possibilities of long acting injectables through population PK modelling. Dickinson, H; Dickinson, J; Dickinson, PA; Gajjar, P; Mistry, HB; Patterson, C; Ruston, L, 2022)	0.72
" Treatments for schizophrenia with longer dosing intervals may provide patients with symptomatic stability that could allow for reduced hospitalisations/relapse and increased focus on functional recovery."	( Persistence and adherence to second-generation antipsychotic long-acting injectable medications for schizophrenia: A comparative study in the Australian context. Brahmbhatt, P; Huang, TH; McGeachie, AB; Pai, N; Puig, A, 2023)	0.91
" Our constructed PBPK model can predict risperidone and paliperidone pharmacokinetics in pregnant and neonatal populations, which could help with precision dosing using the PBPK model-informed approach in special populations."	( Physiologically-based pharmacokinetic model to investigate the effect of pregnancy on risperidone and paliperidone pharmacokinetics: Application to a pregnant woman and her neonate. Fujioka, K; Fujiwara, N; Horai, T; Iijima, K; Imafuku, H; Ito, T; Mahdy, WYB; Omura, T; Otsuka, I; Yamamoto, K; Yano, I, 2023)	0.91
" Both prognostic factors and predictors with increased risk after discontinuation were oral antipsychotic treatment (lower risk for long-acting injectables), higher last dosage of the antipsychotic study drug, shorter duration of antipsychotic treatment, and higher score on the Clinical Global Impression (CGI) severity scale The predictive performance (concordance index) for participants who were not used to train the model was 0·707 (chance level is 0·5)."	( Predicting psychotic relapse following randomised discontinuation of paliperidone in individuals with schizophrenia or schizoaffective disorder: an individual participant data analysis. Ayrilmaz, H; Bermpohl, F; Brandt, L; Gutwinski, S; Hasan, A; Heinz, A; Leucht, S; Montag, C; Ritter, K; Schneider-Thoma, J; Siafis, S; Stuke, H, 2023)	0.91

Class	Description
1,2-benzoxazoles	Compounds based on a fused 1,2-oxazole and benzene bicyclic ring skeleton, with the O atom positioned adjacent to one of the positions of ring fusion.
heteroarylpiperidine
organofluorine compound	An organofluorine compound is a compound containing at least one carbon-fluorine bond.
pyridopyrimidine	Any organic heterobicyclic compound consisting of a pyridine ring ortho-fused at any position to a pyrimidine ring.
fatty acid ester	A carboxylic ester in which the carboxylic acid component can be any fatty acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	19 (1.96)	18.2507
2000's	159 (16.39)	29.6817
2010's	615 (63.40)	24.3611
2020's	177 (18.25)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	208 (20.02%)	5.53%
Reviews	125 (12.03%)	6.00%
Case Studies	172 (16.55%)	4.05%
Observational	42 (4.04%)	0.25%
Other	492 (47.35%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (171)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
An Open-Label, Long-Term, Multiple-Dose, Safety and Tolerability, Pharmacokinetic Study of 150 mg eq. Paliperidone Palmitate in the Treatment of Subjects With Schizophrenia [NCT01150448]	Phase 1	212 participants (Actual)	Interventional	2007-09-30	Completed
Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations [NCT01181960]		1,066 participants (Actual)	Observational	2010-08-31	Completed
Clinical Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings [NCT04940039]	Phase 4	93 participants (Actual)	Interventional	2021-07-22	Active, not recruiting
A Long-Term, Open-Label Study of Flexibly Dosed Paliperidone Palmitate Long-Acting Intramuscular Injection in Japanese Patients With Schizophrenia [NCT01258920]	Phase 3	201 participants (Actual)	Interventional	2010-10-31	Completed
A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric H [NCT01193166]	Phase 4	0 participants (Actual)	Interventional	2010-08-31	Withdrawn(stopped due to This study was stopped due to an internal reconsideration of priorities of the product portfolio.)
A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Determine the Relative Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients [NCT03751488]	Phase 1	48 participants (Actual)	Interventional	2018-12-12	Completed
Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study [NCT01584466]		0 participants (Actual)	Interventional	2014-01-31	Withdrawn
A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate [NCT01362426]		127 participants (Actual)	Observational	2011-03-31	Completed
A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation [NCT03345979]	Phase 3	200 participants (Actual)	Interventional	2017-11-15	Completed
An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom [NCT01498770]		42 participants (Actual)	Observational	2013-04-01	Completed
A Pilot-Study in Rwandan Health Care Settings to Examine the Feasibility of a Large Pragmatic Clinical Study to Assess the Value of Paliperidone Palmitate in Rwanda [NCT03713658]	Phase 4	34 participants (Actual)	Interventional	2018-10-18	Completed
Early Prediction of Clinical Response, Metabolic Change, and Pharmacokinetics in Taiwanese Patients With Schizophrenia Patients Treated by Paliperidone ER: an Open-Label Study [NCT02075528]	Phase 4	41 participants (Actual)	Interventional	2009-07-31	Completed
A Randomized, Double-blind, Placebo-controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Flexible-dose Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder. [NCT00412373]	Phase 3	307 participants (Actual)	Interventional	2006-12-31	Completed
Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study [NCT03485417]	Phase 2/Phase 3	240 participants (Anticipated)	Interventional	2019-06-01	Recruiting
Paliperidone Extended Release Tablets for the Prevention of Relapse in Subjects With Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study [NCT01662310]	Phase 3	201 participants (Actual)	Interventional	2011-06-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response, Multicenter Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release Paliperidone in the Treatment of Subjects With Acute Manic and Mixed Episodes Ass [NCT00299715]	Phase 3	473 participants (Actual)	Interventional	2006-02-28	Completed
A Multicenter Retrospective Study to Analyse the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Patients With Schizophrenia in Portugal [NCT03666715]		55 participants (Actual)	Observational	2018-08-07	Completed
Α Randomized, Two-way, Two-treatment, Two-period, Crossover, Open Label, Laboratory-blind, Comparative Bioavailability Study at Steady State Between Paliperidone 100 mg Prolonged Release Suspension for Injection (Test Product) and Xeplion® 100 mg Prolonge [NCT03425552]	Phase 1/Phase 2	70 participants (Actual)	Interventional	2018-03-11	Completed
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial [NCT02307396]	Phase 4	21 participants (Actual)	Interventional	2015-02-01	Completed
Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism: A Double-blind, Placebo-controlled, Randomized, Parallel Groups, Multi-center Study. [NCT01211704]	Phase 4	0 participants (Actual)	Interventional	2010-10-31	Withdrawn(stopped due to lack of funding)
An Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Paliperidone Extended-Release on the Steady-State Pharmacokinetics of Valproic Acid in Clinically Stable Subjects With Schizophrenia, Bipolar I Disorder or Schizoaffective Disorder [NCT01094249]	Phase 1	9 participants (Actual)	Interventional	2009-02-28	Completed
A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment With Paliperidone Palmitate L [NCT02431702]	Phase 3	337 participants (Actual)	Interventional	2015-07-08	Completed
Open-Label, Parallel, Randomized, Multiple-Dose Pharmacokinetic Study of Paliperidone After Intramuscular Injection of Paliperidone Palmitate in the Deltoid or Gluteal Muscle in Subjects With Schizophrenia [NCT01110317]	Phase 1	49 participants (Actual)	Interventional	2005-07-31	Completed
Mirror-image Study Exploring Relapse and Resource Utilization of Paliperidone Palmitate and Risperidone Long-acting Injection in Vitalité Health Network Patients [NCT03390712]		328 participants (Anticipated)	Observational	2018-01-02	Enrolling by invitation
Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study [NCT01157585]	Phase 4	75 participants (Actual)	Interventional	2010-02-28	Completed
A 6-month, Open Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated With Oral or Long-acting Injectable Antipsychotics [NCT01281527]	Phase 3	1,044 participants (Actual)	Interventional	2010-11-30	Completed
A Study to Evaluate Switching From Risperidone to Paliperidone ER (Extended Release) in the Treatment of Stable But Symptomatic Schizophrenia Outpatients: Patients Satisfaction and Quality of Life [NCT01010776]	Phase 4	223 participants (Actual)	Interventional	2008-02-29	Completed
A Single-dose, Open-label, Randomized, 2-way Crossover Pivotal Bioequivalence Study of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville Under Fasted Condition in Healthy Subjects [NCT00790777]	Phase 1	72 participants (Actual)	Interventional	2007-03-31	Completed
Evaluation of the Dose Proportionality of Two Dose Strengths (1.5 and 3 mg) of Extended-release Paliperidone After a Single Administration to Healthy Men [NCT00791167]	Phase 1	58 participants (Actual)	Interventional	2006-06-30	Completed
The Pharmacokinetics of ER OROS Paliperidone in Subjects With Varying Degrees of Impaired Renal Function (Mild, Moderate, and Severe) as Compared to Subjects With Normal Renal Function [NCT00791401]	Phase 1	47 participants (Actual)	Interventional	2004-04-30	Completed
A Randomized, Open-label, Single-center, Crossover Study of the Potential Effects of Paroxetine on the Pharmacokinetics of a Single Dose of Paliperidone Extended-release in Healthy Men [NCT00791713]	Phase 1	60 participants (Actual)	Interventional	2006-03-31	Completed
Open-label Study to Evaluate the Safety and Pharmacokinetics of Single- and Multiple-dose Extended-release OROS Paliperidone in Pediatric Subjects (=10 to =17 Years of Age) With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder [NCT00796081]	Phase 1	25 participants (Actual)	Interventional	2006-01-31	Completed
A Comparative Evaluation of the Pharmacokinetics and Pharmacodynamics Under Fasting and Fed Conditions of 2 Paliperidone Extended-release Formulations With Paliperidone Oral Solution in Healthy Adults [NCT00796471]	Phase 1	35 participants (Actual)	Interventional	2003-06-30	Completed
Evaluation of the Effect of Food and Posture on the Pharmacokinetics of Paliperidone After a Single Administration of 12 mg ER OROS Paliperidone to Healthy Men [NCT00838669]	Phase 1	74 participants (Actual)	Interventional	2005-08-31	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia [NCT00590577]	Phase 3	652 participants (Actual)	Interventional	2007-03-31	Completed
European Long-acting Antipsychotics in Schizophrenia Trial [NCT02146547]	Phase 4	536 participants (Actual)	Interventional	2015-02-28	Completed
Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of Five Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and Risperidone [NCT02087579]	Phase 1	305 participants (Actual)	Interventional	2014-02-28	Completed
A Study on the Efficacy, Pharmacokinetics and Adverse Effects of Paliperidone ER [NCT02433717]	Phase 4	40 participants (Anticipated)	Interventional	2015-04-30	Recruiting
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of a Fixed Dosage of 1.5 mg/Day of Paliperidone Extended Release (ER) in the Treatment of Subjects With Schizophrenia [NCT00524043]	Phase 4	201 participants (Actual)	Interventional	2007-09-30	Completed
A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Dis [NCT00490971]	Phase 3	768 participants (Actual)	Interventional	2006-05-31	Completed
Dose-proportionality Study of the Five ER OROS Paliperidone To-be-marketed Tablet Strengths (3, 6, 9, 12, and 15 mg) in Healthy Male Subjects [NCT00796835]	Phase 1	50 participants (Actual)	Interventional	2004-07-31	Completed
A 6-Month, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5 - 12 mg/Day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia [NCT00488319]	Phase 3	400 participants (Actual)	Interventional	2007-06-30	Completed
Open-label, Single Arm, Interventional Study to Explore the Efficacy and Safety of Paliperidone ER in the Management of Patients With Acute Agitation and/or Aggression [NCT01050478]	Phase 4	56 participants (Actual)	Interventional	2010-03-31	Completed
A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate With Oral Risperidone in Adults With Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse [NCT00946985]	Phase 4	163 participants (Actual)	Interventional	2009-06-30	Terminated(stopped due to The recruitment rate for the study was inadequate to achieve its enrollment goals.)
Pivotal Bioequivalence Study With 15 mg ER OROS Paliperidone Comparing the Phase 3 Formulation With the To-be-marketed Formulation and Evaluation of Food Effect on the to be Marketed Formulation in Healthy Male Subjects [NCT00892489]	Phase 1	80 participants (Actual)	Interventional	2004-07-31	Completed
A Randomized, Open-Label, Parallel Group Comparative Study of Paliperidone Palmitate (50, 100, 150 mg eq) and Risperidone LAI (25, 37.5, or 50 mg) in Subjects With Schizophrenia [NCT00604279]	Phase 3	452 participants (Actual)	Interventional	2008-01-31	Completed
Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning [NCT00937261]	Phase 4	96 participants (Anticipated)	Interventional	2009-07-31	Recruiting
A Randomized, DB, PC and AC, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS� Paliperidone (6, 9, 12 mg/Day) and Olanzapine (10 mg/Day), With Open-Label Extension, in the Treatment of Sub [NCT00650793]	Phase 3	473 participants (Actual)	Interventional	2004-03-31	Completed
Investigation of the Potential Effects of Trimethoprim on the Pharmacokinetics of ER OROS Paliperidone in Healthy Male Subjects [NCT00892541]	Phase 1	30 participants (Actual)	Interventional	2004-10-31	Completed
An Open-Label, Drug-Drug Interaction Study Between Steady-State Valproic Acid and Single-Dose Paliperidone Extended-Release in Healthy Men [NCT01060228]	Phase 1	24 participants (Actual)	Interventional	2009-01-31	Completed
A Single-arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects With Schizophrenia or Schizoaffective Disorder With Hepatic Disease [NCT00535145]	Phase 4	121 participants (Actual)	Interventional	2007-10-31	Completed
Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics [NCT03730857]	Phase 1	111 participants (Actual)	Interventional	2008-01-31	Completed
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication [NCT03557931]	Phase 2	233 participants (Actual)	Interventional	2018-07-13	Completed
INVega Is Studied In an Observational Design in the Netherlands [NCT00697658]		27 participants (Actual)	Observational	2008-03-31	Completed
Open Label Extension to R076477-SCH-305 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia. [NCT00668837]	Phase 3	407 participants (Actual)	Interventional	2004-02-29	Completed
An Open-label, Single-arm, Multicenter, Phase IV Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia [NCT00915512]	Phase 4	84 participants (Actual)	Interventional	2009-05-31	Completed
An Open-label, Prospective, Non-Comparative Study to Evaluate Subjective Well-Being and Responses in Patients With Schizophrenia Who Had Switched to Paliperidone Extended-Release Tablets [NCT00784238]	Phase 4	289 participants (Actual)	Interventional	2008-04-30	Completed
Disposition of Paliperidone Enantiomers After Treatment With Different Formulations of the Racemate and the Separate Enantiomers and the Determination of the Absolute Bioavailability of IR and ER OROS Paliperidone [NCT00796276]	Phase 1	20 participants (Actual)	Interventional	2004-05-31	Completed
Open-label Positron Emission Tomography (PET) Study of Central D2-receptor Occupancy in Healthy Subjects Following a Single Oral Dose of OROS Paliperidone [NCT00796432]	Phase 1	4 participants (Actual)	Interventional	2003-03-31	Completed
Pharmacokinetics of Paliperidone in Subjects With Moderate Hepatic Impairment as Compared to Subjects With Normal Hepatic Function. [NCT00791284]	Phase 1	20 participants (Actual)	Interventional	2004-08-31	Completed
Open-Label Study of Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder [NCT00592358]	Phase 4	17 participants (Actual)	Interventional	2007-11-30	Terminated(stopped due to Slow enrollment.)
A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia [NCT00589914]	Phase 3	1,221 participants (Actual)	Interventional	2007-03-31	Completed
Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data [NCT02582736]		725,489 participants (Actual)	Observational	2012-04-30	Completed
R076477-SCH-702: a 24 Week Open-Label Extension to R076477-SCH-302 [NCT00752427]	Phase 3	86 participants (Actual)	Interventional	2004-06-30	Completed
A Randomized, Multicenter, Double-Blind, Active-Controlled, Flexible-Dose, Parallel-Group Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Symptoms of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age [NCT01009047]	Phase 3	228 participants (Actual)	Interventional	2009-12-31	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parellel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder [NCT01193153]	Phase 3	667 participants (Actual)	Interventional	2010-09-30	Completed
Pharmacokinetic Evaluation of the Relative Bioavailability of Three Paliperidone Extended Release (ER) Formulations With Different in Vitro Release Profiles, and Comparison to Paliperidone Immediate Release (IR), in Healthy Male Subjects [NCT00791193]	Phase 1	80 participants (Actual)	Interventional	2007-03-31	Completed
A Placebo- and Positive-controlled, Randomized Study Evaluating QT and QTc Intervals Following Administration of Immediate-release Paliperidone in Subjects With Schizophrenia or Schizoaffective Disorder [NCT00791349]	Phase 1	141 participants (Actual)	Interventional	2005-02-28	Completed
Comparison of Steady-state Pharmacokinetics of Paliperidone After Extended-release OROS� Paliperidone 15 mg and Immediate-release Oral Risperidone 8 mg b.i.d. in Subjects With Schizophrenia or Schizoaffective Disorder [NCT00796185]	Phase 1	62 participants (Actual)	Interventional	2003-08-31	Completed
A Comparison of Long-Acting Injectable Medications for Schizophrenia [NCT01136772]	Phase 4	311 participants (Actual)	Interventional	2011-03-31	Completed
Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone [NCT02634463]	Phase 1	81 participants (Actual)	Interventional	2015-11-30	Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Two Dosages of Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder. [NCT00397033]	Phase 3	316 participants (Actual)	Interventional	2006-11-30	Completed
Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation [NCT01134731]	Phase 4	54 participants (Actual)	Interventional	2010-05-31	Completed
A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia [NCT00396565]	Phase 3	394 participants (Actual)	Interventional	2006-07-31	Completed
A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder [NCT05321602]	Phase 1	80 participants (Anticipated)	Interventional	2021-09-08	Recruiting
A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism [NCT00549562]	Phase 3	25 participants (Actual)	Interventional	2007-11-30	Completed
Safety, Tolerability, and Treatment Response of Paliperidone Palmitate in Subjects With Schizophrenia When Switching From Oral Antipsychotics [NCT01051531]	Phase 3	546 participants (Actual)	Interventional	2010-04-30	Completed
Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia [NCT00566631]	Phase 3	294 participants (Actual)	Interventional	2007-07-31	Completed
A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Phase 1 Study to Compare the Tolerability of OROS Paliperidone (Extended Release) With Immediate-release (IR) Risperidone in Subjects With Schizophrenia [NCT00791232]	Phase 1	113 participants (Actual)	Interventional	2003-03-31	Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating QT/QTc Intervals Following Administration of Extended-release Paliperidone and Quetiapine in Subjects With Schizophrenia or Schizoaffective Disorder [NCT00791622]	Phase 1	110 participants (Actual)	Interventional	2006-01-31	Completed
An Open-label Prospective, Non-comparative Study to Evaluate the Subjective Experiences Upon Transition to Paliperidone Extended Release(ER) in Subjects With Schizophrenia [NCT00761605]	Phase 4	387 participants (Actual)	Interventional	2008-04-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Evaluate and Compare the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Subjects. [NCT00758030]	Phase 1	60 participants (Actual)	Interventional	2004-03-31	Completed
An Open-label Prospective Trial to Evaluate the Tolerability, Safety and Maintained Efficacy of a Transition to Paliperidone ER in Subjects With Schizophrenia Previously Unsuccessfully Treated With Other Oral Antipsychotics [NCT00757705]	Phase 4	299 participants (Actual)	Interventional	2008-03-31	Completed
Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD) [NCT00766064]	Phase 4	0 participants (Actual)	Interventional	2008-09-30	Withdrawn
A Blinded-initiation Study of Medication Satisfaction in Subjects With Schizophrenia Treated With Paliperidone ER After Suboptimal Response to Oral Risperidone [NCT00535132]	Phase 4	201 participants (Actual)	Interventional	2007-10-31	Completed
An Open-Label Prospective, Non-Comparative Study To Explore The Tolerability, Safety and Effectiveness Upon Transition to Paliperidone Slow-Release Tablet in Schizophrenic Patients [NCT00761579]	Phase 4	190 participants (Actual)	Interventional	2008-04-30	Completed
An Open Label, Prospective, Non-comparative Study to Evaluate Flexible Dose of Paliperidone Extended-Release and Clinical Response in the Treatment of Subjects With Schizophrenia [NCT00761189]	Phase 4	491 participants (Actual)	Interventional	2008-02-29	Completed
A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic [NCT02600741]		296 participants (Actual)	Observational	2015-07-24	Completed
The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study [NCT01860781]	Phase 4	30 participants (Actual)	Interventional	2011-08-31	Completed
A Comparative Evaluation of the Pharmacokinetics and Pharmacodynamics Under Fasting and Fed Conditions of 2 Paliperidone Extended-release Pellet Formulations With Paliperidone Oral Solution in Healthy Adults [NCT00796640]	Phase 1	35 participants (Actual)	Interventional	2003-09-30	Completed
Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial [NCT00827840]	Phase 4	58 participants (Actual)	Interventional	2008-11-30	Completed
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Versus Non-Clozapine Antipsychotics in Individuals With Treatment-resistant Schizophrenia [NCT05741502]	Phase 4	60 participants (Anticipated)	Interventional	2023-08-16	Recruiting
Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia [NCT01942382]	Phase 1	76 participants (Actual)	Interventional	2009-04-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia [NCT00210548]	Phase 3	366 participants (Actual)	Interventional	2005-04-30	Completed
Safety and Effectiveness of Paliperidone Palmitate in 25-week Treatment on Chinese Patients With Schizophrenia: an Open-label, Single-arm, Multicenter Prospective Study [NCT01947803]	Phase 4	353 participants (Actual)	Interventional	2013-09-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia [NCT01299389]	Phase 3	323 participants (Actual)	Interventional	2010-10-31	Completed
A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monother [NCT01081769]	Phase 3	769 participants (Actual)	Interventional	2010-02-28	Completed
Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter [NCT01685931]	Phase 4	617 participants (Actual)	Interventional	2012-11-30	Completed
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]		1,037,352 participants (Actual)	Observational	2016-09-30	Completed
Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection [NCT01607762]	Phase 1	31 participants (Actual)	Interventional	2012-02-29	Completed
Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral Dose in Healthy Male Subjects [NCT00796029]	Phase 1	5 participants (Actual)	Interventional	2003-07-31	Completed
A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects With Schizophrenia [NCT00645099]	Phase 3	462 participants (Actual)	Interventional	2007-10-31	Completed
Evaluation of the Effect of Carbamazepine on the Steady-state Pharmacokinetics of Paliperidone Extended Release in Clinically Stable Subjects With Schizophrenia or Bipolar I Disorder [NCT00892125]	Phase 1	64 participants (Actual)	Interventional	2006-09-30	Completed
A Randomized, Open-label, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Subjects [NCT00892320]	Phase 1	20 participants (Actual)	Interventional	2004-03-31	Completed
A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age [NCT00518323]	Phase 3	201 participants (Actual)	Interventional	2007-08-31	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROS® Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia - Open Label Phase [NCT00645307]	Phase 3	235 participants (Actual)	Interventional	2004-05-31	Completed
A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated [NCT01157351]	Phase 4	450 participants (Actual)	Interventional	2010-05-31	Completed
A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation [NCT02713282]	Phase 3	306 participants (Actual)	Interventional	2016-04-28	Completed
The Effect of Long-acting Antipsychotic on Schizophrenia Patients With Violence Risk : a Observational Cohort Study [NCT04064476]		225 participants (Anticipated)	Observational	2019-08-18	Enrolling by invitation
Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study [NCT01399450]	Phase 4	11 participants (Actual)	Interventional	2011-08-31	Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects With Schizophrenia [NCT00086320]	Phase 3	111 participants (Actual)	Interventional	2004-03-31	Completed
The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia [NCT04076371]		1,640 participants (Actual)	Interventional	2012-01-31	Completed
The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice [NCT00488891]		43 participants (Actual)	Observational	2007-04-30	Terminated(stopped due to The study was terminated because it was not enrolling at the expected rate)
A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia [NCT02918825]		100 participants (Actual)	Interventional	2016-09-01	Completed
"The Therapeutic Window of the Atypical Antipsychotic Paliperidone Extended Release (ER)-A Positron Emission Tomography Study With [18F]Fallypride as the Radiotracer" [NCT00934635]	Phase 4	2 participants (Actual)	Interventional	2009-09-30	Terminated
Exploratory Study of Paliperidone in Patients With Schizophrenia to Investigate the Safety and Efficacy [NCT00257023]	Phase 2	52 participants (Actual)	Interventional	2005-02-28	Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq, 50 mg eq, and 100 mg eq) of Paliperidone Palmitate in Patients With Schizophrenia [NCT00101634]	Phase 3	518 participants (Actual)	Interventional	2004-12-31	Completed
A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Paliperidone Extended Release Tablets and Olanzapine, With Open-label Extension, in the Treatment of [NCT00077714]	Phase 3	12 participants (Actual)	Interventional	2004-01-31	Completed
A Randomized Double-blind Placebo-controlled Parallel Group Study Evaluating Paliperidone Palmitate in the Prevention of Recurrence in Patients With Schizophrenia. Placebo Consists of 20% Intralipid (200 mg/mL) Injectable Emulsion. [NCT00111189]	Phase 3	414 participants (Actual)	Interventional	2005-02-28	Completed
A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Paliperidone Extended Release in the Treatment of Geriatric Patients With Schizophrenia [NCT00085748]	Phase 3	114 participants (Actual)	Interventional	2004-08-31	Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia [NCT00334126]	Phase 3	399 participants (Actual)	Interventional	2006-04-30	Completed
A Double-blind, Placebo-controlled, Randomized Study Evaluating the Effect of Paliperidone ER Compared With Placebo on Sleep Architecture in Subjects With Schizophrenia [NCT00105326]	Phase 2	5 participants (Actual)	Interventional	2005-02-28	Completed
A Randomized, 6-week Double-blind, Parallel Study to Evaluate the Efficacy and the Safety of Flexible Doses of Extended Release OROS Paliperidone Compared With Olanzapine in the Treatment of Patients With Schizophrenia [NCT00350467]	Phase 3	288 participants (Actual)	Interventional	2006-06-30	Completed
A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Patients With Schizophrenia [NCT00119756]	Phase 3	253 participants (Actual)	Interventional	2005-06-30	Completed
A Randomized, Double-Blind, Parallel Group, Comparative Study of Flexibly Dosed Paliperidone Palmitate (25, 50, 75, or 100 mg eq.) Administered Every 4 Weeks and Flexibly Dosed RISPERDAL CONSTA (25, 37.5, or 50 mg) Administered Every 2 Weeks in Subjects W [NCT00210717]	Phase 3	748 participants (Actual)	Interventional	2005-02-28	Completed
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia [NCT00473434]	Phase 3	64 participants (Actual)	Interventional	2007-04-30	Completed
Different Safety Profile of Risperidone and Paliperidone Extended-release: a Double-blind, Placebo-controlled Trial With Healthy Volunteers [NCT01284959]	Phase 4	34 participants (Actual)	Interventional	2010-06-30	Completed
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia [NCT00460512]	Phase 3	1,814 participants (Actual)	Interventional	2007-04-25	Completed
An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia [NCT01527305]	Phase 4	212 participants (Actual)	Interventional	2012-06-30	Completed
A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (ER) Tablets and Olanzapine, With Open-label Extension, in the Treatmen [NCT00083668]	Phase 3	619 participants (Actual)	Interventional	2004-04-30	Completed
Open-label Extension of A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS� Paliperidone (6 and 12 mg/Day) and Olanzapine (10 mg/D [NCT00210769]	Phase 3	203 participants (Actual)	Interventional	2004-01-31	Completed
Pharmacokinetics, Tolerability, and Safety of Paliperidone After Repeated Intramuscular Injection of Paliperidone Palmitate in the Arm or the Buttock of Subjects With Schizophrenia [NCT00073320]	Phase 3	88 participants (Actual)	Interventional	2003-08-31	Completed
Randomized, Double-blind, Placebo- and Active-controlled Parallel Group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (6, 9, and 12 mg/Day) and Olanzapine (10 mg/Day) With Open-label Extension [NCT00078039]	Phase 3	630 participants (Actual)	Interventional	2004-03-31	Completed
Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) [NCT00330863]	Phase 4	357 participants (Actual)	Interventional	2006-05-31	Completed
Augmentation of Clozapine With Paliperidone in the Treatment of Resistant Schizophrenia Randomized Controlled Study [NCT01279213]	Phase 4	70 participants (Actual)	Interventional	2009-01-31	Completed
A Randomized, Open-Label, Parallel, Single-Dose Study to Evaluate the Pharmacokinetic Characteristics of LY03010 Process 1 and Process 2 Drug Product Versus INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients [NCT04572685]	Phase 1	36 participants (Actual)	Interventional	2020-01-22	Completed
An Open-Label, Comparative Study of Immediate or Delayed Switch to Paliperidone Palmitate in Patients Unsatisfied With Current Oral Atypical Antipsychotics to Evaluate the Evolution of Medication Satisfaction and Adherence [NCT01682161]	Phase 4	154 participants (Actual)	Interventional	2012-01-31	Completed
Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute M [NCT00309699]	Phase 3	493 participants (Actual)	Interventional	2006-04-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episo [NCT00309686]	Phase 3	300 participants (Actual)	Interventional	2006-04-30	Completed
[NCT01742390]	Phase 4	120 participants (Anticipated)	Interventional	2013-02-28	Recruiting
Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis. [NCT01765829]	Phase 3	104 participants (Anticipated)	Interventional	2012-11-30	Recruiting
A Multiple-Center, Randomized, Double-Blind Study of Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis [NCT01822730]	Phase 4	120 participants (Actual)	Interventional	2013-02-28	Completed
Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification [NCT01825928]		80 participants (Actual)	Interventional	2013-02-28	Completed
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy [NCT03019887]		139 participants (Actual)	Interventional	2011-04-30	Completed
Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate - A Pilot Study [NCT01448720]	Phase 3	142 participants (Actual)	Interventional	2011-09-30	Completed
Risk of Breakthrough Symptoms On Antipsychotic Maintenance Medication When Remitted Patients Are Treated With Long-Acting Injectable Medications [NCT05473741]		180 participants (Anticipated)	Observational	2023-01-09	Recruiting
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia [NCT01662648]	Phase 3	1,117 participants (Actual)	Interventional	2007-06-30	Completed
Differences in Lipid and Cognitive Change Between One-month and 3-month Paliperidone Palmitate Treatment in Stable Schizophrenia [NCT04754750]	Phase 1/Phase 2	72 participants (Actual)	Interventional	2015-01-31	Completed
A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Paliperidone Palmitate 3-Month Formulation in Subjects With Schizophrenia [NCT01559272]	Phase 1	328 participants (Actual)	Interventional	2008-02-21	Completed
Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia [NCT01451736]	Phase 4	146 participants (Actual)	Interventional	2011-10-31	Completed
Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder [NCT00632229]	Phase 2	34 participants (Actual)	Interventional	2007-10-31	Completed
A Sequential and Parallel Cohort Design to Test the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry [NCT02462473]	Phase 2	9 participants (Actual)	Interventional	2015-05-31	Terminated(stopped due to Due to poor enrollment sponsor terminated early after enrolling 9 in Cohort 1 and no enrollment in Cohorts 2 and 3.)
A Study to Evaluate the PK Profiles of LY03010 and Relative Bioavailability at Steady-state of LY03010 Versus INVEGA SUSTENNA in Schizophrenia Patients [NCT04922593]	Phase 1	281 participants (Actual)	Interventional	2021-01-13	Completed
A Long-Term Study of JNS007ER in Patients With Schizophrenia [NCT01561898]	Phase 3	228 participants (Actual)	Interventional	2006-06-30	Completed
Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER [NCT01577186]	Phase 4	480 participants (Actual)	Interventional	2008-07-31	Completed
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]	Phase 3	407 participants (Actual)	Interventional	2015-01-31	Terminated
The Effect of a Community-based Long-acting Antipsychotic-treated Management Model on the Violence Risk of Patients With Schizophrenia: a 1-year, Open-label Randomized Controlled Study [NCT03080194]	Phase 4	150 participants (Anticipated)	Interventional	2017-04-30	Not yet recruiting
Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis [NCT06060886]	Phase 4	244 participants (Anticipated)	Interventional	2023-11-01	Not yet recruiting
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia [NCT01724359]	Phase 4	95 participants (Actual)	Interventional	2008-02-29	Completed
Efficacy and Tolerability of Flexible Doses of Paliperidone ER in Symptomatic Subjects With Schizophrenia With Duration of Illness < 10 Years [NCT01362439]	Phase 4	133 participants (Actual)	Interventional	2009-01-31	Completed
A Repeated Dose Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia [NCT01606254]	Phase 2	56 participants (Actual)	Interventional	2007-01-31	Completed
Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT) [NCT00806234]	Phase 4	127 participants (Actual)	Interventional	2009-01-31	Completed
A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia [NCT01795547]	Phase 3	295 participants (Actual)	Interventional	2013-02-28	Completed
A Concierge Model of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAL-C) in Individuals With Schizophrenia at Risk for Treatment Non-adherence and for Homelessness [NCT02085447]		30 participants (Actual)	Interventional	2014-05-31	Completed
An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia [NCT01577160]	Phase 4	353 participants (Actual)	Interventional	2008-05-31	Completed
A Randomized, Open-Label, Study To Evaluate The Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Selected Cognitive Domains in Clinically Stable Subjects With Schizophrenia [NCT01670071]	Phase 4	17 participants (Actual)	Interventional	2013-01-31	Terminated(stopped due to The study was terminated due to insufficient sample size and protocol compliance issue.)
An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT) [NCT01387542]	Phase 4	40 participants (Actual)	Interventional	2009-08-31	Completed
Estimating the Optimal Dynamic Antipsychotic Treatment Regime: Sequential Multiple-assignment Randomized Clinical Antipsychotic Trials in Chinese Patients With First-episode Psychosis. [NCT03510325]	Phase 4	1,260 participants (Anticipated)	Interventional	2018-10-01	Not yet recruiting
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Non Acute Episode Subjects With Schizophrenia [NCT01541371]	Phase 3	405 participants (Actual)	Interventional	2008-07-31	Completed
Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly [NCT03809325]		225 participants (Actual)	Observational	2018-11-21	Completed
An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia [NCT01606228]	Phase 3	188 participants (Actual)	Interventional	2007-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00330863 (3) [back to overview]	Substantial Clinical Deterioration Measured by Psychotic Symptoms
NCT00330863 (3) [back to overview]	Side Effects and Metabolic Measures
NCT00330863 (3) [back to overview]	Number of Patients Discontinuing From the Study
NCT00396565 (6) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
NCT00396565 (6) [back to overview]	Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
NCT00396565 (6) [back to overview]	Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
NCT00396565 (6) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
NCT00396565 (6) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
NCT00396565 (6) [back to overview]	Change From Baseline in Clinical Global Impression Scale (CGI-S)
NCT00397033 (18) [back to overview]	Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
NCT00397033 (18) [back to overview]	Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
NCT00397033 (18) [back to overview]	Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
NCT00397033 (18) [back to overview]	Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score
NCT00397033 (18) [back to overview]	The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.
NCT00397033 (18) [back to overview]	Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
NCT00397033 (18) [back to overview]	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score
NCT00397033 (18) [back to overview]	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score
NCT00397033 (18) [back to overview]	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score
NCT00397033 (18) [back to overview]	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score
NCT00397033 (18) [back to overview]	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score
NCT00397033 (18) [back to overview]	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score
NCT00397033 (18) [back to overview]	Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
NCT00397033 (18) [back to overview]	Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder
NCT00397033 (18) [back to overview]	Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
NCT00397033 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score
NCT00397033 (18) [back to overview]	Number of Participants With Response
NCT00397033 (18) [back to overview]	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
NCT00412373 (18) [back to overview]	Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
NCT00412373 (18) [back to overview]	Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
NCT00412373 (18) [back to overview]	Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Participants With Response
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
NCT00412373 (18) [back to overview]	Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
NCT00412373 (18) [back to overview]	Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
NCT00473434 (11) [back to overview]	The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
NCT00473434 (11) [back to overview]	The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
NCT00473434 (11) [back to overview]	The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
NCT00473434 (11) [back to overview]	The Length of Hospitalizations Throughout the Study
NCT00473434 (11) [back to overview]	The Global Assessment of Functioning (GAF) Throughout the Study
NCT00473434 (11) [back to overview]	The Clinical Global Impression of Severity (CGI-S) Throughout the Study
NCT00473434 (11) [back to overview]	The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
NCT00473434 (11) [back to overview]	The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
NCT00473434 (11) [back to overview]	The Number of Hospitalizations Throughout the Study
NCT00473434 (11) [back to overview]	The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
NCT00473434 (11) [back to overview]	The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
NCT00488319 (20) [back to overview]	Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward
NCT00488319 (20) [back to overview]	Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward
NCT00490971 (7) [back to overview]	Clinical Global Impression - Bipolar Disorder - Severity of Illness (CGI-BP-S): Change From Baseline
NCT00490971 (7) [back to overview]	Global Assessment of Functioning (GAF): Change From Baseline
NCT00490971 (7) [back to overview]	Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00490971 (7) [back to overview]	Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder
NCT00490971 (7) [back to overview]	Young Mania Rating Scale (YMRS): Change From Baseline
NCT00490971 (7) [back to overview]	Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder
NCT00490971 (7) [back to overview]	Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder
NCT00518323 (5) [back to overview]	Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.
NCT00518323 (5) [back to overview]	Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness
NCT00518323 (5) [back to overview]	Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale
NCT00518323 (5) [back to overview]	Change From Baseline to End Point in Children's Global Assessment (CGAS) Score
NCT00518323 (5) [back to overview]	Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.
NCT00524043 (5) [back to overview]	Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score
NCT00524043 (5) [back to overview]	Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score
NCT00524043 (5) [back to overview]	Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score
NCT00524043 (5) [back to overview]	Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S
NCT00524043 (5) [back to overview]	Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment).
NCT00535132 (15) [back to overview]	Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.
NCT00535132 (15) [back to overview]	Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).
NCT00535132 (15) [back to overview]	Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.
NCT00535132 (15) [back to overview]	Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint
NCT00535132 (15) [back to overview]	Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).
NCT00535132 (15) [back to overview]	Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint
NCT00535132 (15) [back to overview]	Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint
NCT00535132 (15) [back to overview]	Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint
NCT00535145 (4) [back to overview]	The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER
NCT00535145 (4) [back to overview]	Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline
NCT00535145 (4) [back to overview]	Clinical Global Impression of Severity (CGI-S) Change From Baseline
NCT00535145 (4) [back to overview]	Personal and Social Performance Score (PSP) Change From Baseline
NCT00549562 (5) [back to overview]	The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders
NCT00549562 (5) [back to overview]	The Clinical Global Impression-Improvement(CGI-I)
NCT00549562 (5) [back to overview]	The Social Responsiveness Scale
NCT00549562 (5) [back to overview]	The Aberrant Behavior Checklist
NCT00549562 (5) [back to overview]	The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain
NCT00566631 (12) [back to overview]	Number of Participants Satisfied With the Study Treatment
NCT00566631 (12) [back to overview]	Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
NCT00566631 (12) [back to overview]	Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Number of Participants With Treatment Response Based on Total PANSS Scale Score
NCT00566631 (12) [back to overview]	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00566631 (12) [back to overview]	Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
NCT00589914 (3) [back to overview]	Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
NCT00589914 (3) [back to overview]	The Change From Baseline for the CGI-S Score
NCT00589914 (3) [back to overview]	The Change From Baseline in the PSP Score
NCT00590577 (3) [back to overview]	Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.
NCT00590577 (3) [back to overview]	Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment
NCT00590577 (3) [back to overview]	Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment
NCT00592358 (2) [back to overview]	Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist
NCT00592358 (2) [back to overview]	Change in Symptoms Measured by Young Mania Rating Scale (YMRS)
NCT00604279 (5) [back to overview]	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal
NCT00604279 (5) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal
NCT00604279 (5) [back to overview]	Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal
NCT00604279 (5) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal
NCT00604279 (5) [back to overview]	Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal
NCT00632229 (2) [back to overview]	Yale Brown Obsessive Compulsive Scale
NCT00632229 (2) [back to overview]	Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms
NCT00645099 (19) [back to overview]	Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up
NCT00645099 (19) [back to overview]	Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in High Density Lipoprotein
NCT00645099 (19) [back to overview]	Change From Baseline at End Point of the Insulinogenic Index
NCT00645099 (19) [back to overview]	Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin
NCT00645099 (19) [back to overview]	Change From Baseline at End Point in Waist Circumference
NCT00645099 (19) [back to overview]	Change From Baseline at End Point in Body Weight
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Total Cholesterol
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Converted Insulin
NCT00645099 (19) [back to overview]	Change From Baseline at End Point in Body Mass Index (BMI)
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Fasting Glucose
NCT00645099 (19) [back to overview]	Number of Patients With Onset of Impaired Glucose Tolerance
NCT00645099 (19) [back to overview]	Change From Baseline to End Point in Triglycerides
NCT00645099 (19) [back to overview]	Number of Patients With Impaired Fasting Glucose
NCT00757705 (9) [back to overview]	Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24
NCT00757705 (9) [back to overview]	Number of Participants With Satisfaction With the Study Treatment
NCT00757705 (9) [back to overview]	Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
NCT00757705 (9) [back to overview]	Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24
NCT00757705 (9) [back to overview]	Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24
NCT00757705 (9) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
NCT00757705 (9) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24
NCT00757705 (9) [back to overview]	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24
NCT00757705 (9) [back to overview]	Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00761189 (12) [back to overview]	Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
NCT00761189 (12) [back to overview]	Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
NCT00761189 (12) [back to overview]	Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
NCT00761189 (12) [back to overview]	Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
NCT00761189 (12) [back to overview]	Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population
NCT00761189 (12) [back to overview]	Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population
NCT00761189 (12) [back to overview]	Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
NCT00761189 (12) [back to overview]	Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
NCT00761189 (12) [back to overview]	Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
NCT00761189 (12) [back to overview]	Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population
NCT00761189 (12) [back to overview]	Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
NCT00761189 (12) [back to overview]	Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
NCT00761579 (10) [back to overview]	Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Sleep Quality at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Daytime Drowsiness at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48
NCT00761579 (10) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48
NCT00761605 (8) [back to overview]	Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
NCT00761605 (8) [back to overview]	Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
NCT00761605 (8) [back to overview]	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
NCT00761605 (8) [back to overview]	Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24
NCT00761605 (8) [back to overview]	Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
NCT00761605 (8) [back to overview]	Change From Baseline in Krawiecka Scale Score at Week 24
NCT00761605 (8) [back to overview]	Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
NCT00761605 (8) [back to overview]	Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Krawiecka Scale Score at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
NCT00784238 (14) [back to overview]	Drug Attitude Inventory (DAI-10) Total Score at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
NCT00784238 (14) [back to overview]	Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
NCT00784238 (14) [back to overview]	Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24
NCT00806234 (4) [back to overview]	Body Mass Index (BMI) Z-score Change
NCT00806234 (4) [back to overview]	Change in Low Density Lipoprotein (LDL) Cholesterol Level
NCT00806234 (4) [back to overview]	Change in Whole Body Insulin Sensitivity Index
NCT00806234 (4) [back to overview]	Triglyceride Levels
NCT00934635 (1) [back to overview]	Percentage of Paliperidone or Risperidone Dopamine D2 Receptor Occupancies
NCT01009047 (9) [back to overview]	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
NCT01009047 (9) [back to overview]	Number of Participants With Clinical Stability
NCT01009047 (9) [back to overview]	Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
NCT01009047 (9) [back to overview]	Number of Participants With PANSS Response
NCT01009047 (9) [back to overview]	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
NCT01009047 (9) [back to overview]	Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
NCT01009047 (9) [back to overview]	Change From Baseline in PANSS Total Score at Day 182
NCT01009047 (9) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
NCT01009047 (9) [back to overview]	Change From Baseline in Other Marder Factors Scores at Day 56 and 182
NCT01010776 (18) [back to overview]	Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase
NCT01010776 (18) [back to overview]	Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase
NCT01010776 (18) [back to overview]	Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase
NCT01010776 (18) [back to overview]	Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	Percentage of Participants With Treatment Satisfaction - Main Phase
NCT01010776 (18) [back to overview]	Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase
NCT01010776 (18) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase
NCT01010776 (18) [back to overview]	Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase
NCT01010776 (18) [back to overview]	Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	36-Item Short-Form Health Survey (SF-36) Score - Main Phase
NCT01010776 (18) [back to overview]	36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase
NCT01010776 (18) [back to overview]	Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase
NCT01010776 (18) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase
NCT01081769 (15) [back to overview]	Change From Baseline in Patient's Treatment Satisfaction
NCT01081769 (15) [back to overview]	Change From Baseline in PANSS Total Score
NCT01081769 (15) [back to overview]	Change From Baseline in PANSS Subscale Score
NCT01081769 (15) [back to overview]	Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score
NCT01081769 (15) [back to overview]	Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score
NCT01081769 (15) [back to overview]	Number of Participants With a Relapse Event
NCT01081769 (15) [back to overview]	Percentage of Treatment Responders
NCT01081769 (15) [back to overview]	Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score
NCT01081769 (15) [back to overview]	Change From Baseline in Short Form-36 Health Survey (SF-36)
NCT01081769 (15) [back to overview]	Change From Baseline in Physician's Treatment Satisfaction
NCT01081769 (15) [back to overview]	Changes From Baseline in Personal and Social Performance (PSP) Total Score
NCT01081769 (15) [back to overview]	Change From Baseline in PANSS Marder Factor Scores
NCT01081769 (15) [back to overview]	Time to First Relapse Event
NCT01081769 (15) [back to overview]	Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
NCT01081769 (15) [back to overview]	Clinical Global Impression-Change (CGI-C)
NCT01134731 (2) [back to overview]	Mean Score of Montgomery-Asberg Depression Scale of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment
NCT01134731 (2) [back to overview]	Mean Score of Beck Scale for Suicidal Ideation of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment
NCT01136772 (2) [back to overview]	Changes in Psychiatric Symptoms
NCT01136772 (2) [back to overview]	Efficacy Failure
NCT01157351 (6) [back to overview]	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
NCT01157351 (6) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
NCT01157351 (6) [back to overview]	Time to First Psychiatric Hospitalization
NCT01157351 (6) [back to overview]	Time to First Psychiatric Hospitalization or Arrest/Incarceration
NCT01157351 (6) [back to overview]	Time to First Treatment Failure
NCT01157351 (6) [back to overview]	Percentage of Participants in Each Event Category of First Treatment Failure
NCT01193153 (13) [back to overview]	Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores
NCT01193153 (13) [back to overview]	Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])
NCT01193153 (13) [back to overview]	Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
NCT01193153 (13) [back to overview]	Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
NCT01193153 (13) [back to overview]	Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
NCT01193153 (13) [back to overview]	Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
NCT01193153 (13) [back to overview]	Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
NCT01193153 (13) [back to overview]	Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint
NCT01193153 (13) [back to overview]	Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint
NCT01193153 (13) [back to overview]	Double-blind: Percentage of Participants Who Experienced Relapse
NCT01193153 (13) [back to overview]	Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint
NCT01193153 (13) [back to overview]	Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
NCT01193153 (13) [back to overview]	Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint
NCT01284959 (7) [back to overview]	Assessment of Cognitive Functioning-3
NCT01284959 (7) [back to overview]	Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales
NCT01284959 (7) [back to overview]	Symptoms Assessment by Objective Rating Scales
NCT01284959 (7) [back to overview]	Assessment of Cognitive Functioning-1
NCT01284959 (7) [back to overview]	Assessment of Adverse Events by Objective Rating Scales and Self Report Scales
NCT01284959 (7) [back to overview]	Assessment of Adverse Events by Objective Rating Scales and Self Report Scales
NCT01284959 (7) [back to overview]	Assessment of Cognitive Functioning-2
NCT01299389 (7) [back to overview]	Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation
NCT01299389 (7) [back to overview]	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation
NCT01299389 (7) [back to overview]	Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation
NCT01299389 (7) [back to overview]	Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation
NCT01299389 (7) [back to overview]	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation
NCT01299389 (7) [back to overview]	Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation
NCT01299389 (7) [back to overview]	Participants With Response to the Treatment as Per PANSS Total Score.
NCT01362439 (12) [back to overview]	Quality of Sleep Score
NCT01362439 (12) [back to overview]	Daytime Drowsiness Evaluation Scale
NCT01362439 (12) [back to overview]	Clinical Global Impression-Severity Scale (CGI-S)
NCT01362439 (12) [back to overview]	Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13
NCT01362439 (12) [back to overview]	Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13
NCT01362439 (12) [back to overview]	Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13
NCT01362439 (12) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
NCT01362439 (12) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13
NCT01362439 (12) [back to overview]	Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13
NCT01362439 (12) [back to overview]	Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13
NCT01362439 (12) [back to overview]	Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score
NCT01362439 (12) [back to overview]	Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
NCT01387542 (4) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10
NCT01387542 (4) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2
NCT01387542 (4) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6
NCT01387542 (4) [back to overview]	Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10
NCT01541371 (8) [back to overview]	Number of Participants With Satisfaction With the Study Treatment
NCT01541371 (8) [back to overview]	Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12
NCT01541371 (8) [back to overview]	Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
NCT01541371 (8) [back to overview]	Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01541371 (8) [back to overview]	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12
NCT01541371 (8) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12
NCT01541371 (8) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12
NCT01541371 (8) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
NCT01561898 (3) [back to overview]	Change From Baseline in Clinical Global Impression - Severity (CGI-S)
NCT01561898 (3) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS)
NCT01561898 (3) [back to overview]	Incidence of Adverse Events
NCT01577160 (5) [back to overview]	Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
NCT01577160 (5) [back to overview]	Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
NCT01577160 (5) [back to overview]	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
NCT01577160 (5) [back to overview]	Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
NCT01577160 (5) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
NCT01577186 (5) [back to overview]	Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
NCT01577186 (5) [back to overview]	Social Functioning Scale (SFS) Score
NCT01577186 (5) [back to overview]	Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
NCT01577186 (5) [back to overview]	Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
NCT01577186 (5) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
NCT01606228 (12) [back to overview]	Clinical Global Impression-Severity (CGIS) Scores at Day 90
NCT01606228 (12) [back to overview]	Clinical Global Impression-Severity (CGIS) Scores at Baseline
NCT01606228 (12) [back to overview]	The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
NCT01606228 (12) [back to overview]	Daytime Drowsiness at Day 90
NCT01606228 (12) [back to overview]	Personal and Social Performance (PSP) Scores at Baseline
NCT01606228 (12) [back to overview]	Personal and Social Performance (PSP) Scores at Day 90
NCT01606228 (12) [back to overview]	Patient Satisfaction With Paliperidone Treatment
NCT01606228 (12) [back to overview]	Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
NCT01606228 (12) [back to overview]	Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
NCT01606228 (12) [back to overview]	Daytime Drowsiness at Baseline
NCT01606228 (12) [back to overview]	Quality of Sleep at Baseline
NCT01606228 (12) [back to overview]	Quality of Sleep at Day 90
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92
NCT01606254 (19) [back to overview]	Positive and Negative Syndrome Scale (PANSS) Total Score
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8
NCT01606254 (19) [back to overview]	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
NCT01606254 (19) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of Paliperidone
NCT01606254 (19) [back to overview]	Paliperidone Plasma Decay Half-Life (t1/2)
NCT01606254 (19) [back to overview]	Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36
NCT01606254 (19) [back to overview]	Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64
NCT01606254 (19) [back to overview]	Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8
NCT01606254 (19) [back to overview]	Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92
NCT01606254 (19) [back to overview]	Plasma Paliperidone Concentration at Steady State (Css av)
NCT01606254 (19) [back to overview]	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone
NCT01606254 (19) [back to overview]	Number of Participants With Clinical Global Impression Severity (CGI-S) Score
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218
NCT01606254 (19) [back to overview]	Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22
NCT01662310 (15) [back to overview]	Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14
NCT01662310 (15) [back to overview]	Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint
NCT01662310 (15) [back to overview]	Double Blind (DB) Phase: Median Time to Relapse
NCT01662310 (15) [back to overview]	Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint
NCT01662310 (15) [back to overview]	Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint
NCT01662310 (15) [back to overview]	Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint
NCT01662310 (15) [back to overview]	Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14
NCT01662310 (15) [back to overview]	Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
NCT01662310 (15) [back to overview]	Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14
NCT01662310 (15) [back to overview]	Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint
NCT01662310 (15) [back to overview]	Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)
NCT01662310 (15) [back to overview]	Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14
NCT01662310 (15) [back to overview]	Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint
NCT01662310 (15) [back to overview]	Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint
NCT01662310 (15) [back to overview]	Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint
NCT01662648 (9) [back to overview]	Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26
NCT01662648 (9) [back to overview]	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
NCT01662648 (9) [back to overview]	Change From Baseline in Sleep Quality at Week 26
NCT01662648 (9) [back to overview]	Number of Participants Within Each Category of Patient Satisfaction Score
NCT01662648 (9) [back to overview]	Change From Baseline in Daytime Drowsiness at Week 26
NCT01662648 (9) [back to overview]	Change From Baseline in PANSS Total Negative Subscale Score at Week 26
NCT01662648 (9) [back to overview]	Change From Baseline in PANSS Total Positive Subscale Score at Week 26
NCT01662648 (9) [back to overview]	Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26
NCT01662648 (9) [back to overview]	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26
NCT01724359 (9) [back to overview]	Health Status as Measured by Self-rated Health Status Survey SF-36
NCT01724359 (9) [back to overview]	Daytime Drowsiness Evaluation Scale
NCT01724359 (9) [back to overview]	Clinical Global Impression-Severity (CGIS)
NCT01724359 (9) [back to overview]	Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
NCT01724359 (9) [back to overview]	Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
NCT01724359 (9) [back to overview]	Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score
NCT01724359 (9) [back to overview]	Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
NCT01724359 (9) [back to overview]	Personal and Social Performance (PSP) Scale
NCT01724359 (9) [back to overview]	Sleep Evaluation Scale
NCT01795547 (9) [back to overview]	Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in the TooL Total Score
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in CGI-S Score
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in SWN-S Total Score
NCT01795547 (9) [back to overview]	Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
NCT02085447 (22) [back to overview]	Change in CGI (Clinical Global Impression) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in DAI (Drug Attitudes Index) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Akathisia)
NCT02085447 (22) [back to overview]	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dyskinesia) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dystonia) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Parkinsonism) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in Hospitalizations (Medical) in the Past 6 Months From Screen and Week 25
NCT02085447 (22) [back to overview]	Change in Hospitalizations (Psychiatric) in the Past 6 Months From Screen and Week 25
NCT02085447 (22) [back to overview]	Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in PANSS (Positive and Negative Syndrome Scale; General Psychopathology) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in SAS (Simpson Angus Scale) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit
NCT02085447 (22) [back to overview]	Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25
NCT02085447 (22) [back to overview]	Long-acting Injection (LAI) Adherence
NCT02085447 (22) [back to overview]	Percentage Change of Days of Sub-optimal Housing in the Past Six Months; Change From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in SOFAS (Social and Occupational Functioning Assessment Scale) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in AIMS (Abnormal Involuntary Movement Scale) From Baseline to Week 25
NCT02085447 (22) [back to overview]	Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in ASSIST GRS (Alcohol, Smoking and Substance Involvement Screening Test ) From Screen to Week 25
NCT02085447 (22) [back to overview]	Change in BARS (Barnes Akathisia Rating Scale) From Screen to Week 25
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Verbal Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (Disease Modification): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (SE MRI)
NCT02431702 (31) [back to overview]	Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]	Part 3 (Disease Modification): Personal and Social Performance (PSP) Total Observed Score
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Attention/Vigilance Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Score
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (EDP): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by CRDPSS
NCT02431702 (31) [back to overview]	Part-2 (Disease Progression): Time to First Treatment Failure
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS)
NCT02431702 (31) [back to overview]	Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]	Part 3 (EDP): Time to First Treatment Failure
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Visual Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Speed of Processing Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 3 (EDP): Change From Baseline in Social Cognition Score: MCCB Domain
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]	Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
NCT02462473 (8) [back to overview]	Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
NCT02462473 (8) [back to overview]	Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
NCT02462473 (8) [back to overview]	Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
NCT02462473 (8) [back to overview]	Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
NCT02462473 (8) [back to overview]	Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
NCT02462473 (8) [back to overview]	Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
NCT02462473 (8) [back to overview]	Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
NCT02462473 (8) [back to overview]	Number of Participants With Medication Treatment Modifications (MTM)
NCT03019887 (1) [back to overview]	Number of Participants With Relapse
NCT03345979 (7) [back to overview]	Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
NCT03345979 (7) [back to overview]	Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
NCT03345979 (7) [back to overview]	Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
NCT03345979 (7) [back to overview]	Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
NCT03345979 (7) [back to overview]	Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
NCT03345979 (7) [back to overview]	Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
NCT03345979 (7) [back to overview]	Number of Participants With Serious and Non-serious Adverse Events (AEs)
NCT03557931 (8) [back to overview]	Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score
NCT03557931 (8) [back to overview]	Change From Baseline to Week 12/End of Treatment (EoT) in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
NCT03557931 (8) [back to overview]	Concentration at Trough Level (Ctrough) for ASP4345
NCT03557931 (8) [back to overview]	Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values
NCT03557931 (8) [back to overview]	Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values
NCT03557931 (8) [back to overview]	Number of Participants With Clinically Significant Differences in Simpson Angus Scale (SAS) Values
NCT03557931 (8) [back to overview]	Number of Participants With Adverse Event (AE)
NCT03557931 (8) [back to overview]	Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values

Substantial Clinical Deterioration Measured by Psychotic Symptoms

Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms. (NCT00330863)
Timeframe: Measured throughout study up to 30 months

Intervention	units on a scale (Least Squares Mean)
Injectable	1.8
Oral	2.0

Intervention	units on a scale (Mean)
	Bruising easily	Rash	Urticaria (hives, itching)	Blurred vision	sedation/drowsiness	Restlessness	Insomnia	Malaise (weakness, fatigue)	Stiffness	Tremor	Dizziness	Headache	Fever	Sore Throat	Dry Mouth	Hypersalivation	Enuresis	Constipation	Diarrhea	Anorexia (loss of appetite)	Nausea	Vomiting	Menstrual Irregularity	Breast tenderness/galactorrhea
Injectable	1.43	1.53	1.60	1.76	2.34	2.48	2.38	2.22	2.01	1.77	1.82	1.99	1.27	1.64	2.36	1.76	1.63	1.75	1.65	1.89	1.78	1.48	1.62	1.39
Oral	1.48	1.44	1.71	1.91	2.53	2.43	2.36	2.14	1.97	1.75	1.78	1.89	1.24	1.57	2.25	1.84	1.56	1.64	1.68	1.69	1.72	1.51	1.55	1.32

Intervention	scores on a scale (Mean)
Paliperidone Extended Release (ER) (JNS007ER)	-2.6
Placebo	1.6
Olanzapine	-2.4

Intervention	Percentage of participants (Number)
Paliperidone Extended Release (ER) (JNS007ER)	25.4
Placebo	9.4
Olanzapine	26.1

Intervention	scores on a scale (Mean)
Paliperidone Extended Release (ER) (JNS007ER)	-9.1
Placebo	3.8
Olanzapine	-9.9

Intervention	scores on a scale (Mean)
Paliperidone Extended Release (ER) (JNS007ER)	-4.1
Placebo	2.2
Olanzapine	-4.7

Intervention	scores on a scale (Mean)
Paliperidone Extended Release (ER) (JNS007ER)	-0.4
Placebo	0.2
Olanzapine	-0.3

Intervention	points on a scale (Mean)
Placebo	24.4
Paliperidone Extended Release (ER) Low Dose	25.2
Paliperidone Extended Release (ER) High Dose	26.9

Intervention	points on a scale (Mean)
Placebo	91.6
Paliperidone Extended Release (ER) Low Dose	95.9
Paliperidone Extended Release (ER) High Dose	92.7

Intervention	points on scale (Mean)
Placebo	-21.7
Paliperidone Extended Release (ER) Low Dose	-27.4
Paliperidone Extended Release (ER) High Dose	-30.6

Intervention	points on scale (Mean)
Placebo	-11.5
Paliperidone Extended Release (ER) Low Dose	-14.3
Paliperidone Extended Release (ER) High Dose	-19.4

Intervention	points on a subscale (Mean)
Placebo	-4.8
Paliperidone Extended Release (ER) Low Dose	-5.4
Paliperidone Extended Release (ER) High Dose	-7.0

Intervention	points on subscale (Mean)
Placebo	-7.9
Paliperidone Extended Release (ER) Low Dose	-9.1
Paliperidone Extended Release (ER) High Dose	-11.3

Intervention	points on a subscale (Mean)
Placebo	-3.1
Paliperidone Extended Release (ER) Low Dose	-4.4
Paliperidone Extended Release (ER) High Dose	-4.2

Intervention	points on a subscale (Mean)
Placebo	-3.0
Paliperidone Extended Release (ER) Low Dose	-4.5
Paliperidone Extended Release (ER) High Dose	-4.0

Intervention	points on a subscale (Mean)
Placebo	-10.7
Paliperidone Extended Release (ER) Low Dose	-13.9
Paliperidone Extended Release (ER) High Dose	-15.1

Intervention	points on a subscale (Mean)
Placebo	-3.4
Paliperidone Extended Release (ER) Low Dose	-4.5
Paliperidone Extended Release (ER) High Dose	-4.3

Intervention	points on scale (Mean)
Placebo	-1.1
Paliperidone Extended Release (ER) Low Dose	-1.4
Paliperidone Extended Release (ER) High Dose	-1.8

Intervention	points on a scale (Mean)
Placebo	28.5
Paliperidone Extended Release (ER) Low Dose	28.4
Paliperidone Extended Release (ER) High Dose	29.9

Intervention	points on a subscale (Mean)
Placebo	-6.7
Paliperidone Extended Release (ER) Low Dose	-8.0
Paliperidone Extended Release (ER) High Dose	-9.6

Intervention	points on a subscale (Mean)
Placebo	-3.7
Paliperidone Extended Release (ER) Low Dose	-5.0
Paliperidone Extended Release (ER) High Dose	-5.7

paliperidone palmitate

Description

Cross-References

Synonyms (69)

Research Excerpts

Overview

Effects

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Drug Classes (5)

Research

Studies (970)

Market Indicators

Research Demand Index: 68.41

Study Types

Clinical Trials (171)

Trial Overview

Trial Outcomes

Substantial Clinical Deterioration Measured by Psychotic Symptoms

Side Effects and Metabolic Measures

Number of Patients Discontinuing From the Study

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score

Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])

Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score

Change From Baseline in Clinical Global Impression Scale (CGI-S)

Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16

Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline

Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder

Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score

The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.

Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16

Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score

Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score

Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score

Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score

Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score

Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score

Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16

Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder

Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16

Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score

Number of Participants With Response

Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score

Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.

Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder

Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline

Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Participants With Response

Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.

Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16

Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16

The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12

The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84

The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84

The Length of Hospitalizations Throughout the Study

The Global Assessment of Functioning (GAF) Throughout the Study

The Clinical Global Impression of Severity (CGI-S) Throughout the Study

The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84

The Percentage of Participants Presenting Clinical Deterioration Throughout the Study

The Number of Hospitalizations Throughout the Study

The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12

The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84

Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward

The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability

Intervention	days (Mean)
Baseline	12.4
Week 2	66
Week 4	7.3
Week 6	28.0
Week 9	179.0
Week 12	34
Week 20	19
Week 44	4
Week 52	20.5

Intervention	scores on a scale (Mean)
Baseline	54.6
Week 2	58.9
Week 4	63.9
Week 6	63.9
Week 9	66.3
Week 12	65.4
Week 20	65.1
Week 28	71.1
Week 36	71.6
Week 44	69.0
Week 52	63.3

Intervention	percentage of participants (Number)
	Hospitalized	Care Increase	Suicidal	Violent	Self Injury
Baseline	0	0	4.8	0	0
Week 12	3.2	3.2	0	0	3.2
Week 2	5.3	0	5.3	0	0
Week 20	3.7	7.4	0	0	0
Week 28	0	0	0	0	0
Week 36	0	0	0	0	0
Week 4	13.5	5.4	8.1	0	0
Week 44	0	5.9	0	0	0
Week 52	12.5	12.5	0	0	0
Week 6	5.9	2.9	0	0	0
Week 9	7.1	3.6	0	0	0

Intervention	Scores on a scale (Mean)
Placebo/Paliperidone	3.4
Paliperidone (Double-blind)/Paliperidone	4.1
Paliperidone (No Double-blind)/Paliperidone	5.6
Total	4.9

Intervention	Number of Participants (Number)
	Treatment Emergent Adverse Events (TEAEs)	Possibly-related TEAEs	One or More Serious TEAEs
Paliperidone (Double-blind)/Paliperidone	88	61	4
Paliperidone (No Double-blind)/Paliperidone	221	185	46
Placebo/Paliperidone	32	24	9
Total	341	270	59

Intervention	Scores on a scale (Mean)
	Positive Symptoms	Negative Symptoms	Disorganized Thoughts	Uncontrolled Hostility/Excitement	Anxiety/Depression
Paliperidone (Double-blind)/Paliperidone	-3.4	-3.8	-3.3	-1.2	-0.9
Paliperidone (No Double-blind)/Paliperidone	-7.0	-5.7	-4.9	-2.1	-2.8
Placebo/Paliperidone	-5.1	-4.3	-4.8	-2.6	-2.1
Total	-5.7	-5.0	-4.4	-1.9	-2.2

Intervention	Scores on a scale (Mean)
	Finger Tapping Dominant Hand	Finger Tapping Non Dominant Hand
Paliperidone (Double-blind)/Paliperidone	0.1	0.4
Paliperidone (No Double-blind)/Paliperidone	0.3	0.2
Placebo/Paliperidone	0.2	0.2
Total	0.2	0.3

Intervention	Scores on a scale (Mean)
Placebo/Paliperidone	-7.4
Paliperidone (Double-blind)/Paliperidone	-5.1
Paliperidone (No Double-blind)/Paliperidone	-3.9
Total	-4.6

Intervention	Scores on a scale (Median)
Placebo/Paliperidone	-1.0
Paliperidone (Double-blind)/Paliperidone	-1.0
Paliperidone (No Double-blind)/Paliperidone	-1.0
Total	-1.0

Intervention	Scores on a scale (Mean)
Placebo/Paliperidone	29.0
Paliperidone (Double-blind)/Paliperidone	3.5
Paliperidone (No Double-blind)/Paliperidone	8.2
Total	7.2