Risperidone placebo-controlled studies

Chouinard G, Jones B, Remington G, et al (1993). A Canadian multicentre placebo controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic inpatients./Clin Psychopharmacol25—40. 

McDougle CJ, Epperson CN, Pelton GH, Wasylink S, Price LH (2000) A double-blind, placebo-controlled study of risperidone addition in serotonin reuptake inhibitor-refractory obsessive-compulsive disorder. Arch Gen Psychiatry 57 794-801... 

McDougle, C.J., Holmes, J.P., Carlson, D.C., Pelton, G.H., Cohen, D.J., and Price, L.H., (1998b) A double-blind placebo-controlled study of risperidone in adults with autistic disorder and other pervasive developmental disorders. Arch Gen Psychiatry 55 633-641. 

In the Expert Consensus survey, the respondents endorsed risperidone, olanzapine, and quetiapine, in that order, followed by high-potency traditional antipsychotics, for managing self-injury. A placebo-controlled study comparing risperidone with a classical antipsychotic, such as haloperidol, could provide valuable data for this field. 

Aman, M.G., De Smedt, G., Derivan, A., Lyons, B., Findling, R.L., and the Risperidone Disruptive Behavior Study Group (In press). Risperidone treatment of children with disruptive behavior symptoms and subaverage IQ a double-blind, placebo-controlled study. Am J Psychiatry... 

In an open trial in boys suffering from outbursts, risperidone decreased aggression, explosivity, and self-injury (Horrigan and Barnhill, 1997). Sleep and hygiene improved as well. In a 10-week double-blind, placebo-controlled study, Findling et al. (2000) found that risperidone improved conduct symptoms and aggression. 

In a double-blind, placebo-controlled study of the addition of low-dose risperidone (mean dosage 2.2 mg/day) to a 5-HT re-uptake inhibitor in refractory obsessive-compulsive disorder in 70 adults, 18 of 20 risperidone-treated patients had at least one adverse effect (37). The adverse effects in both groups included sedation (n = 17 for risperidone, n = 8 for placebo), increased appetite (6 and 3), restlessness (6 and 6), and dry mouth (5 and 5). 

In a 12-week, double-blind, randomized, placebo-controlled study in 40 patients with treatment-resistant schizophrenia (funded by Johnson Johnson Pharmaceutical Research Development), the addition of risperidone to clozapine improved overall symptoms and positive and negative symptoms (49). The adverse events profile of clozapine + risperidone was similar to that of clozapine + placebo. Clozapine + risperidone did not cause additional weight gain, agranulocytosis, or seizures compared with clozapine + placebo. All the patients completed 12 weeks of treatment however, the small sample size precluded definitive conclusions. 

In a two-phase placebo-controlled study with an initial sample of 45 patients, 39 of whom completed the study, the addition of low doses of risperidone (0.5 mg/day) appeared to improve symptoms in patients with obsessive-compulsive disorder taking fluvoxamine monotherapy (51). The main adverse events included transient sedation and mildly increased appetite. 

Aman MG, De Smedt G, Derivan A, Lyons B, Findling RLRisperidone Disruptive Behavior Study Group. Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Am J Psychiatry 2002 159(8) 1337-46. 

Erzegovesi S, Guglielmo E, Siliprandi F, Bellodi L. Low-dose risperidone augmentation of fluvoxamine treatment in obsessive-compulsive disorder a double-blind, placebo-controlled study. Eur Neuropsychopharmacol 2005 15 69-74. 

Until the advent of the atypical antipsychotics, conventional agents were widely used, although available placebo-controlled studies suggested that they were moderately effective at best. More recently, risperidone has been shown to have modest effects in patients with psychotic symptoms or behavioral disturbances associated with dementia. " It is recommended to begin with 0.25 mg daily and to titrate in 0.25- to 0.5-mg increments to 1 mg daily, which is usually considered the optimal dose. If response is inadequate, further titrating to a maximum of 2 mg daily may be necessary if the patient is tolerating the medication however, side effects, particularly extrapyramidal effects, somnolence, and orthostasis, increase with increased dose. 

Alexopoulos GS, Canuso CM, Gharabawi GM, Bossie CA, Greenspan A, Turkoz I, Reynolds 3rd C. Placebo-controlled study of relapse prevention with risperidone augmentation in older patients with resistant depression. Am J Geriatr Psychiatry 2008 16(1) 21-30. 

Kent JM, Kushner S, Ning X, Karcher K, Ness S, Aman M, et al. Risperidone dosing in children and adolescents with autistic disorder a double-blind, placebo-controlled study. J Autism Dev Disord 2013 43(8) 1773-83. 

These results were subsequently replicated in a double-blind, placebo-controlled crossover study (Heresco-Levy et al., 2005) in which D-serine or a placebo was added to atypical antipsychotics (risperidone... 

Adults with autistic disorder (n = 17) or pervasive developmental disorder not otherwise specified (n = 14) participated in a randomized, 12-week, double-blind, placebo-controlled trial of risperidone (41). Among those who completed the study, risperidone (n = 14) was superior to placebo (n = 16) in reducing the symptoms of autism, and the most prominent adverse effect was mild transient sedation during the initial phase of drug administration. Abnormal gait was reported in one patient taking risperidone. 

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