Risperidone studies/trials

Katz IR, Jeste DV, Mintzer JE, et al Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia a randomized, double-blind trial Risperidone Study Group. J Clin Psychiatry 60 107-115, 1999... 

Controlled trials comparing risperidone with typical drugs have provided inconclusive results overall. Of five non-randomized studies (Table 2.5) only one (Malla, 1998) indicated that risperidone use might result in lower costs by reducing time spent in hospital. 

The Clinical Antipsychotic Trials of Intervention Effectiveness study showed that olanzapine, compared with quetiapine, risperidone, ziprasi-... 

Of the atypical antipsychotics, clozapine, olanzapine, and risperidone have been studied the most. Clozapine was used to treat 10 treatment refractory acutely manic patients and 15 schizomanic patients. Using reduction in the YMRS score as the outcome measure, 72% improved (non-rapid cycling, bipolar patients). Comparison of olanzapine (5-20 mg) with placebo showed significant reduction of the YMRS in 49% vs. 24% of subjects by 3 weeks, with significant change evident by the first week. In a trial comparing risperidone at 6 mg with haloperidol at 10 mg and low-dose lithium (800-1200 mg/day) efficacy was similar over the 28 days of the trial. 

Recently, Janssen Pharmaceutica launched several studies of risperidone in children with borderline IQ or MR and a diagnosis of disruptive behavior disorder (usually oppositional defiant disorder or conduct disorder). To be admissible into the study, subjects needed to be 5 to 12 years old, inclusive, and score above 24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (NCBRF). One 6-week acute trial (n = 118) was conducted in the United States (Aman et al., in press), whereas the other n = 110) was based in Canada (Snyder et al., in press). The findings of the two studies were virtually identical, with... 

There have been numerous trials of use of the atypical antipsychotics in patients with developmental disabilities, but most of these trials were uncontrolled open-labeled studies or case reports (Aman and Madrid, 1999). Findings were reported for 86 adults and 1 child with prominent self-injury. The reports of adults assessed clozapine (1 report) and risperidone (4 reports). Improvement was observed for a majority of participants in all of these trials. The patients presented with a multitude of conditions, ranging from nonspecific MR and associated behavior problems, to pervasive developmental disorders (including autism), to various psychiatric disorders, including schizophrenia and manic disorder. Self-injury appeared to respond to treatment regardless of concomitant condition. In the only clozapine report with a child (who had autistic disorder), a mean dose of 283 mg/day caused a transient reduction in self-injury. 

EPS, extrapyramidal side effects HPD, haloperidol MLD, molindone N, total number of subjects in study , number of preschool-age children in study RCT, randomized, double-blind, controlled trial RISP, risperidone SE, side effect TFP, trifluperidol THX, thiothixene. 

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. 

Lavretsky H, Sultzer D A structured trial of risperidone for the treatment of agitation in dementia. Am J Geriatr Psychiatry 6 127-135, 1998 Lawlor BA, Sunderland T, Mellow AM, et al Hyper responsivity to the serotonin agonist m-chlorophenylpiperazine in Alzheimer s disease a controlled study. Arch Gen Psychiatry 46 542-549, 1989a... 

Because a therapeutic window has been hypothesized to exist for neuroleptics, its existence for risperidone is a reasonable supposition. Indeed, evidence to support such a window was established in the North American Clinical Trial and the International Collaborative Study, both of which found doses of 4, 6, and 8 mg superior to higher or lower doses of risperidone. 

Janicak et al. (87) studied the relative efficacy and safety of risperidone versus haloperidol in the treatment of schizoaffective disorder. Sixty-two patients (29 depressed type, 33 bipolar type) entered a randomized, double-blind, 6-week trial of risperidone (up to 10 mg/day) or haloperidol (up to 20 mg/day). They found no difference between risperidone and haloperidol in the amelioration of psychotic and manic symptoms nor any significant worsening of mania with either agent. For the total PANSS, risperidone produced a mean decrease of 16 points from baseline, compared with a 14-point decrease with haloperidol. For the total CARS-M scale, risperidone and haloperidol produced mean change scores of 5 and 8 points, respectively and for the CARS-M mania factor, 3 and 7 points, respectively. 

Risperidone Acute Clinical Trials. Hillert et al. (107) found risperidone to have both antipsychotic and antidepressive properties in 10 patients with schizoaffective disorder, depressed type. These investigators prescribed 2 to 10 mg/day for 6 weeks in an open-label pilot study, and found marked improvement in psychosis in all patients and clinically significant overall improvement in psychosis in 7 to 10 patients. Two patients required antiparkinsonian drugs otherwise risperidone was well tolerated by the group. 

Whether diabetes is associated, and to what extent, with a particular antipsychotic drug or a particular type of antipsychotic drug is a matter of debate since the two most commonly used atypical antipsychotic drugs are risperidone and olanzapine, comparison of these two drugs has been a recent focus of attention. There are more case reports for clozapine and olanzapine, but the studies discussed below have reached conflicting results further information from clinical trials is needed. 

There has been one comprehensive meta-analysis including over 80 studies and over 30 000 patients (814). A meta-analysis of trials of neuroleptic drugs showed the following mean weight gains in kg after 10 weeks of treatment clozapine, 4.5 olanzapine, 4.2 thioridazine, 3.2 sertindole, 2.9 chlorpromazine, 2.6 risperidone, 2.1 haloperidol, 1.1 fluphenazine, 0.43 ziprasidone 0.04 molindone, —0.39 placebo, —0.74... 

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