J&J Medical Connect
RISPERDAL®

(risperidone)

RISPERDAL - pivotal clinical trial publications

 

Adult schizophrenia

Chouinard G, Jones B, Remington G. A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients. J Clin Psychopharmacol. 1993;13(1):25-40.

Marder SR, Meibach RC. Risperidone in the treatment of schizophrenia. Am J Psychiatry. 1994;151(6):825-835.

Marder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin Psychiatry. 1997;58:538-546.

Peuskens J. Risperidone in the treatment of patients with chronic schizophrenia: a multi-national, multi-centre, double-blind, parallel-group study versus haloperidol. Br J Psychiatry. 1995;166:712-726.

Csernansky JG, Mahmoud R, Brenner R, the USA-790 Study group. A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia. New Eng J Med. 2002(1)16-22.

 

Adolescent schizophrenia trials

Haas M, Unis AS, Armenteros J. A 6-week, randomized, double-blind, placebo-controlled study of the efficacy and safety of risperidone in adolescents with schizophrenia. J Child Adolesc Psychopharmacol. 2009;19(6):611-621.

Haas M, Eerdekens M, Kushner S. Efficacy, safety, and tolerability of two risperidone dosing regimens in adolescent schizophrenia: double-blind study. Brit J Psychiatry. 2009;194(2):158-164.

 

Bipolar disorder monotherapy - adult

Hirschfeld R, Keck P, Kramer M. Rapid antimanic effect of risperidone monotherapy: A 3 week multicenter, double-blind, placebo-controlled trial. Am J Psychiatry. 2004; 161:1057-1065.

Khanna S, Vieta E, Lyons B. Risperidone in the treatment of acute mania. Br J Psychiatry. 2005; 187:229-234.

 

Bipolar mania-adjunctive therapy with lithium or valproate - adult

Sachs GS, Grossman F, Ghaemi SN. Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind, placebo-controlled comparison of efficacy and safety. Am J Psychiatry. 2002;159:1146-1154.

Yatham LN, Grossman F, Augustyns I. Mood stabilizers plus risperidone or placebo in the treatment of acute mania. Br J Psychiatry. 2003; 182:141-147.

 

Bipolar disorder in children and adolescents

Haas M, DelBello MP, Pandina G, et al. Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder: a randomized, double-blind, placebo-controlled study. Bipolar Disord. 2009;11:687-700.

 

Irritability associated with autistic disorder

McCracken JT, McGough J, Bhavik S, et al. Risperidone in children with autism and serious behavioral problems. N Eng J Med. 2002;347:314-321.

Pandina GJ, Bossie CA, Youssef E, et al. Risperidone improves behavioral symptoms in children with autism in a randomized, double-blind, placebo-controlled trial. J Autism Dev Disord. 2007;37:367-373.

Kent JM, Kushner S, Ning X, et al. Risperidone dosing in children and adolescents with autistic disorder: a double-blind, placebo-controlled study. J Autism Dev Disord. 2013;43(8):1773-1783.

Aman MG, Arnold LE, McDougle CJ, et al. Acute and long-term safety and tolerability of risperidone in children with autism. J Child Adolesc Psychopharmacol. 2005;15(6):869-884.