Supplemental Digital Content 1
Protocol # Citation
PLACEBO- CONTROLLED STUDIES
RIS-INT-3 Marder SR, Meibach RC. Risperidone in the treatment of schizophrenia.
American Journal of Psychiatry 1994; 151:825-835 RIS-USA-1
(RIS-USA-9001)
Borison RL, Pathiraja AP, Diamond BI, Meibach RC. Risperidone: clinical safety and efficacy in schizophrenia. Psychopharmacology Bulletin 1992; 28(2):213- 218.
RIS-USA-72
Potkin SG, Gutierrez R. Safety and efficacy of once-daily risperidone in the treatment of schizophrenia. Proceedings of the 150th Annual Meeting of the American Psychiatric Association; 1997 May 17-22; San Diego, California, USA.
1997.
RIS-SCH-302
Haas M, Unis AS, Armenteros J, Copenhaver MD, Quiroz JA, Kushner SF. A 6- week, randomized, double-blind, placebo-controlled study of the efficacy and safety of risperidone in adolescents with schizophrenia. Journal of Child and Adolescent Psychopharmacology 2009; 19(6):611-621.
RIS-USA-121
Kane JM, Eerdekens M, Lindenmayer JP, Keith SJ, Lesem M, Karcher K. Long- acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. American Journal of Psychiatry 2003;160:1125-1132.
RIS-IND-2
Khanna S, Vieta E, Lyons B, Grossman F, Eerdekens M, Kramer M. Risperidone in the treatment of acute mania: double-blind, placebo-controlled study. British Journal of Psychiatry 2005;187,:229-234.
RIS-USA-239
Hirschfeld RMA, Keck PE, Kramer M, Karcher K, Canuso C, Eerdekens M, Grossman F. Rapid antimanic effect of risperidone monotherapy: A 3-week multicenter, double-blind, placebo-controlled trial. American Journal of Psychiatry 2004; 161(6):1057-1065.
RIS-INT-69
Smulevich AB, Khanna S, Eerdekens M, Karcher K, Kramer M, Grossman F.
Acute and continuation risperidone monotherapy in bipolar mania: A 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol. European Neuropsychopharmacology 2005; 15:75-84.
RIS-BIM-301
Haas M, Delbello MP, Pandina G, Kushner S, Van Hove I, Augustyns I, Quiroz J, Kusumakar V. Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder: A randomized, double-blind, placebo-controlled study. Bipolar Disorders 2009; 11(7):687-700.
RIS-USA-240 Study terminated for business reasons after 39 patients randomized. Hence these results were never published.
RIS-INT-46
Yatham LN, Grossman F, Augustyns I, Vieta E, Ravindran A. Mood stabilisers plus risperidone or placebo in the treatment of acute mania. international, double- blind, randomised controlled trial. British Journal of Psychiatry 2003; 182:141- 147.
RIS-USA-102
Sachs GS, Grossman F, Ghaemi SN, Okamoto A, Bowden CL. Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: A double-blind, placebo-controlled comparison of efficacy and safety. American Journal of Psychiatry 2002; 159:1146-1154.
RIS-INT-39 (RIS- GBR-28)
Gagiano C, Read S, Thorpe L, Eerdekens M, Van Hove I. Short- and long-term efficacy and safety of risperidone in adults with disruptive behavior disorders.
Psychopharmacology 2005; 179(3):629-636.
RIS-BEL-24
Van Bellinghen M, De Troch C. Risperidone in the treatment of behavioral disturbances in children and adolescents with borderline intellectual functioning:
A double-blind, placebo-controlled pilot trial. Journal of Child and Adolescent Psychopharmacology 2001 Spring;11(1):5-13.
RIS-CAN-19
Aman M, Buitelaar J, De Smedt G, Wapenaar R, Binder C. Pharmacotherapy of disruptive behavior and item changes on a standardized rating scale: Pooled analysis of risperidone effects in children with subaverage IQ. Journal of Child and Adolescent Psychopharmacology 2005; 15(2):220-232.
RIS-NED-9
Buitelaar JK, Van Der Gaag RJ, Cohen-Kettenis P, Melman CT. A randomized controlled trial of risperidone in the treatment of aggression in hospitalized adolescents with subaverage cognitive abilities. Journal of Clinical Psychiatry 2001; 62(4):239-48.
RIS-USA-93
Aman MG, De Smedt G, Derivan A, Lyons B, Findling RL and the Risperidone Disruptive Behavior Study Group. Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. American Journal of Psychiatry 2002; 59(8):1337-1346.
RIS-CAN-23
Shea S, Turgay A, Carroll A, Schulz M, Orlik H, Smith I, Dunbar F. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics 2004; 114 (5):P.E634-E641.
RIS-USA-150
Mcdougle CJ, Scahill L, Aman MG, McCracken JT, Tierney E, Davies M, Arnold LE, Posey DJ, Martin A, Ghuman JK, Shah B, Chuang SZ, Swiezy NB, Gonzalez NM, Hollway J, Koenig K, Mcgough JJ, Ritz L, Vitiello B. Risperidone for the core symptom domains of autism: Results from the study by the Autism Network of the Research Units on Pediatric Psychopharmacology. American Journal of Psychiatry 2005; 162(6):1142-1148.
RIS-BEL-14
Main results from study not published. Analysis of mortality data from this study published in: Haupt M, Cruz-Jentoft A, Jeste D. Mortality in elderly dementia patients treated with risperidone. Journal of Clinical Psychopharmacology 2006;
26(6):566-70.
RIS-INT-83
Study terminated for business reasons after 18 patients randomized, hence the main results from this study were never published. Analysis of mortality data from this study published in: Haupt M, Cruz-Jentoft A, Jeste D. Mortality in elderly dementia patients treated with risperidone. Journal of Clinical Psychopharmacology 2006; 26(6):566-70.
RIS-AUS-5
Brodaty H, Ames D, Snowdon J, Woodward M, Kirwan J, Clarnette R, Lee E, Greenspan A. Risperidone for psychosis of alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial. International Journal of Geriatric Psychiatry 2005; 20(12):1153-1157.
RIS-INT-24
De Deyn PP, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg PLJ, Eriksson S, Lawlor BA. A randomized trial of risperidone, placebo, and
haloperidol for behavioral symptoms of dementia. Neurology 1999; 53:946-955.
RIS-USA-63
Grossman F, Okamoto A, Turkoz I, Gharabawi G. Risperidone in the treatment of elderly patients with psychosis of alzheimer's disease and related dementias.
Journal of the American Geriatrics Society 2004; 52(4):852-853.
RIS-USA-232
Mintzer J, Greenspan A, Caers I, Van Hove I, Kushner S, Weiner M, Gharabawi G, Schneider LS. Risperidone in the treatment of psychosis of alzheimer disease:
Results from a prospective clinical trial. American Journal of Geriatric Psychiatry 2006; 14(3):280-291.
R076477-SCH-1010
Luthringer R, Staner L, Noel N, Muzet M, Gassmann-Mayer C, Talluri K, Cleton A, Eerdekens M, Battisti WP, Palumbo JM. A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia. International Clinical
Psychopharmacology 2007; 22(5):299-308, [Erratum: 22(6):387].
R076477-SCH-1014
Hough DW, Natarajan J, Vandebosch A, Rossenu S, Kramer M, Eerdekens M.
Evaluation of the effect of paliperidone extended release and quetiapine on corrected QT intervals: A randomized, double-blind, placebo-controlled study.
International Clinical Psychopharmacology 2011; 26(1):25-34.
R076477-P01-1005 Synopsis online at Veritas Medicine:
http://Veritasmedicine.com/PDF/CR004933_CSR.PDS. Also cited in the Invega
package insert for Japan (in Japanese): Available at:
http://www.info.pmda.go.jp/downfiles/ph/PDF/800155_1179053G1023_1_04.pdf
R076477-SCH-302
Tzimos A, Samokhvalov V, Kramer M, Ford L, Gassmann-Mayer C, Lim P, Eerdekens M. 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. American Journal of Geriatric Psychiatry 2008; 16:31-43.
R076477-SCH-303
Kane J, Canas F, Kramer M, Ford L, Gassmann-Mayer C, Lim P, Eerdekens M.
Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial. Schizophrenia Research 2007; 90(1-3):147-161.
R076477-SCH-304
Marder SR, Kramer M, Ford L, Eerdekens E, Lim P, Eerdekens M, Lowy A.
Efficacy and safety of paliperidone extended-release tablets: Results of a 6-week, randomized, placebo-controlled study. Biological Psychiatry 2007; 62(12):1363- 1370.
R076477-SCH-305
Davidson M, Emsley R, Kramer M, Ford L, Pan G, Lim P, Eerdekens M.
Efficacy, Safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study.
Schizophrenia Research 2007; 93(1-3):117-130 [Erratum: 96(1-3):272-274].
R092670-SCH-201
Kramer M, Litman R, Hough D, Lane R, Lim P, Liu Y, Eerdekens M.
Paliperidone palmitate, a potential long-acting treatment for patients with
schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. The International Journal of Neuropsychopharmacology 2010;
13(5):635-647.
R092670-PSY-3003
Gopal S, Hough DW, Xu HY, Lull JM, Gassmann-Mayer C, Remmerie BM, Eerdekens MH, Brown DW. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: A randomized, double-blind, placebo-controlled, dose-response study. International Clinical
Psychopharmacology 2010; 25(5):247-256.
R092670-PSY-3004
Nasrallah HA, Gopal S, Gassmann-Mayer C, Quiroz JA, Lim P, Eerdekens M, Yuen E, Hough D. A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology 2010; 35(10):2072-2082.
R092670-PSY-3007
Pandina GJ, Lindenmayer JP, Lull J, Lim P, Gopal S, Herben V, Kusumakar V, Yuen E, Palumbo J. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. Journal of Clinical Psychopharmacology 2010; 30(3):235-244 [Erratum 30(4):364].
R076477-BIM-3001
Berwaerts J, Xu H, Nuamah I, Lim P, Hough D. Evaluation of the efficacy and safety of paliperidone extended-release in the treatment of acute mania: A randomized double-blind dose-response study. Journal of Affective Disorders, Epub Ahead of Print, 2010.
R076477-BIM-3002
Vieta E, Nuamah IF, Lim P, Yuen EC, Palumbo JM, Hough DW, Berwaerts J. A randomized placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder. Bipolar Disorders 2010; 12(3):230-243.
R076477-BIM-3003
Berwaerts J, Lane R, Nuamah IF, Lim P, Remmerie B, Hough DW. Paliperidone extended-release as adjunctive therapy to lithium or valproate in the treatment of acute mania: A randomized, placebo-controlled study. Journal of Affective Disorders 2011; 129(1-3):252-260.
R076477-SCA-3001
Canuso CM, Lindenmayer JP, Kosik-Gonzalez C, Turkoz I, Carothers J, Bossie CA, Schooler NR. A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. Journal of Clinical Psychiatry 2010; 71(5):587-598.
R076477-SCA-3002
Canuso CM, Schooler N, Carothers J, Turkoz I, Kosik-Gonzalez C, Bossie CA, Walling D, Lindenmayer JP. 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.
Journal of Clinical Psychopharmacology 2010; 30(5):487-495.
Active Control, No Placebo Studies
RIS-AUT-1
Main results from this study were not published. However an analysis of EPS data from this study was published in: Lemmens P, Brecher M, Van Baelen B. A combined analysis of double-blind studies with risperidone vs. placebo and other antipsychotic agents: factors associated with extrapyramidal symptoms. Acta Psychiatrica Scandinavica 1999; 99:160-170.
RIS-BEL-5
Claus A, Bollen J, De Cuyper H, Eneman M, Malfroid M, Peuskens J, Heylen S.
Risperidone versus haloperidol in the treatment of chronic schizophrenic inpatients: A multicentre double-blind comparative study. Acta Psychiatrica Scandinavica 1992; 85:295-305.
RIS-BEL-7
Mesotten F, Suy E, Pietquin M, Burton P, Heylen S, Gelders Y. Therapeutic effect and safety of increasing doses of risperidone (R 64766) in psychotic patients.
Psychopharmacology (Berl). 1989; 99(4):445-449.
RIS-FIN-1
Huttunen MO, Piepponen T, Rantanen H, Larmo I, Nyholm R, Raitasuo V.
Risperidone versus zuclopenthixol in the treatment of acute schizophrenic episodes: A double-blind parallel-group trial. Acta Psychiatrica Scandinavica 1995; 91(4):271-277.
RIS-FRA-3
Blin O, Azorin JM, Bouhours P. Antipsychotic and anxiolytic properties of risperidone, haloperidol and methotrimeprazine. Journal of Clinical Psychopharmacology 1996; 16(1):38-44.
RIS-GER-5
Heinrich K, Klieser E, Lehmann E, Kinzler E, Hruschka H. Risperidone versus clozapine in the treatment of schizophrenic patients with acute symptoms: A double blind, randomized trial. Progress in Neuropsychopharmacology and Biological Psychiatry 1994; 18(1):129-137.
RIS-GER-7
Müller-Siecheneder F, Müller MJ, Hillert A, Szegedi A, Wetzel H, Benkert O.
Risperidone versus haloperidol and amitriptyline in the treatment of patients with a combined psychotic and depressive syndrome. Journal of Clinical
Psychopharmacology 1998; 18(2):111-120.
RIS-INT-2
Moeller HJ, Baeuml J, Ferrero F, Fuger J, Geretsegger C, Kasper S, Kissling W, Schubert H. Risperidone in the treatment of schizophrenia: results of a study of patients from Germany, Austria, and Switzerland. European Archives of Psychiatry and Clinical Neuroscience 1997; 247:291-296.
RIS-INT-7
Høyberg OJ, Fensbo C, Remvig J, Lingjaerde O, Sloth-Nielsen M, Salvesen I.
Risperidone versus perphenazine in the treatment of chronic schizophrenic patients with acute exacerbations. Acta Psychiatrica Scandinavica1993;
88(6):395-402.
RIS-INT-9
Main results from this study were not published. However an analysis of EPS was published in: Lemmens P, Brecher M, Van Baelen B. A combined analysis of double-blind studies with risperidone vs. placebo and other antipsychotic agents:
Factors associated with extrapyramidal symptoms. Acta Psychiatrica Scandinavica 1999; 99:160-170.
RIS-KOR-1
Min SK, Rhee CS, Kim CE, Kang DY. Risperidone versus haloperidol in the treatment of chronic schizophrenic patients: A parallel group double-blind comparative trial. Yonsei Medical Journal 1993; 34(2):179-190.
RIS-SUI-1
Bondolfi G, Dufour H, Patris M, May JP, Billeter U, Eap CB, Baumann P.
Risperidone versus clozapine in treatment-resistant chronic schizophrenia: A randomized double-blind study. The Risperidone Study Group. American Journal of Psychiatry 1998; 155(4):499-504.
RIS-INT-6
López Ibor JJ, Ayuso JL, Gutiérrez M, Guimon J, Herraiz ML, Chinchilla A, Ayuso JL Jr, González Pinto A, Eguiluz I, Fernández A. [Risperidone in the treatment of chronic schizophrenia: Multicenter study comparative to haloperidol]. [Article In Spanish]. Actas Luso-españolas de Neurología, Psiquiatría y Ciencias Afines 1996; 24(4):165-172.
RIS-USA-79
Csernansky JG, Mahmoud R, Brenner R. A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia. New England Journal of Medicine 2002; 346:16-22.
RIS-INT-5
Emsley RA. Risperidone in the treatment of first-episode psychotic patients: A double-blind multicenter study. Risperidone Working Group. Schizophrenia Bulletin 1999; 25(4):721-729.
RIS-INT-35
Schooler N, Rabinowitz J, Davidson M, Emsley R, Harvey PD, Kopala L, McGorry PD, Van Hove I, Eerdekens M, Swyzen W, De Smedt G, and the Early Psychosis Global Working Group. Risperidone and haloperidol in first-episode psychosis: A long-term randomized trial. American Journal of Psychiatry 2005;
162(5):947-953.
RIS-INT-45
Conley RR, Mahmoud R. A randomized double-blind study of risperidone and olanzapine in the treatment of schizophrenia or schizoaffective disorder. American Journal of Psychiatry 2001;158(5):765-774.
RIS-USA-112
Berry SA, Gudelsky GA, Mahmoud RA. Serum prolactin levels in schizophrenia.
56th Annual Convention and Scientific Program of the Society of Biological Psychiatry, New Orleans, Louisiana, USA, May 3-5, 2001. Biological Psychiatry 2001; 49(8, Suppl.):22S.
RIS-INT-50
Jeste DV, Barak Y, Madhusoodanan S, Grossman F, Gharabawi G. International multisite double-blind trial of the atypical antipsychotics risperidone and olanzapine in 175 elderly patients with chronic schizophrenia. American Journal of Geriatric Psychiatry 2003; 11(6):638-646, [Erratum: 2004;12(1):49].
RIS-INT-61
Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, Pretorius H, David As. Comparative efficacy and safety of long-acting risperidone and risperidone oral tablets. European Neuropsychopharmacology 2005; 15:111-117.
RIS-INT-62
Rabinowitz J, Khan A, Augustyns I, Ingham M. Non-inferiority efficacy trial of risperidone long-acting injection vs. olanzapine tablets. 13th Biennial Winter Workshop on Schizophrenia Research, and Meeting of the Schizophrenia International Research Society (SIRS), Davos, Switzerland, February 4-10, 2006.
Schizophrenia Research 2006; 81(Suppl.):94-95.
PAL-SCH-101
Cleton A, Rossenu S, Talluri K, Francetic I, Remmerie B, Janssens L, Eerdekens M, Boom S. Evaluation of the pharmacokinetics of an extended-release
formulation of paliperidone with an immediate-release formulation of risperidone.
2007 Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Anaheim, California, USA, March 21-24, 2007. Clinical Pharmacology and Therapeutics 2007; 81(Suppl.1):S62.
R092670-PSY-3002
Fleischhacker WW, Gopal S, Lane R, Gassmann-Mayer C, Lim P, Hough D, Remmerie B, Eerdekens M. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. International Journal of Neuropsychopharmacology. Available online ahead of print. 2011
Doi:10.1017/S1461145711001076.
