Research and Clinical Trials on Risperidone (Risperdal)

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By Dr Greg Mulhauser

This list of current clinical research trials on Risperidone (Risperdal) is followed by a short set of abstracts from the most recent research articles published on the drug.

Article Contents

Risperidone (Risperdal) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Risperidone (Risperdal).

 

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Current Research Literature on Risperidone (Risperdal)

Here are abstracts for some of the latest research articles to have appeared on Risperidone (Risperdal):

Effects of formulation parameters on encapsulation efficiency and release behavior of risperidone poly(D,L-lactide-co-glycolide) microsphere.

Chem Pharm Bull (Tokyo). 2009 Nov; 57(11): 1251-6
Su Z, Sun F, Shi Y, Jiang C, Meng Q, Teng L, Li Y
A 4-week sustained release risperidone biodegradable poly(D,L-lactide-co-glycolide) (PLGA) microsphere for the therapy of schizophrenia, the effects of formulation parameters on encapsulation efficiency and release behavior were studied. The risperidone PLGA microspheres were prepared by O/W solvent evaporation method and characterized by HPLC, SEM, laser particle size analysis, GC and HPLC-MS. The results indicated that the morphology of the risperidone PLGA microspheres presented a spherical shape with smooth surface, the particle size was distributed from 32 to 92 microm and the drug encapsulation efficiency was influenced by homogeneous rotation speed, intrinsic viscosity, carboxylic terminal group, the polymer concentration in the oil phase and the molecular weight of the polymer. These changes were also reflected in drug release. When the Mw of the polymers increased from ca. 28000 to ca. 90000, the initial burst release of risperidone PLGA microspheres decreased from 13 to 0.8% and the sustained-release could be extended to 4 weeks. Pharmacokinetic study on beagle dogs showed that the 4-week sustained release profile of the risperidone loaded microspheres prepared with 75253A was verified. The PLGA 75253A and 75255A show the potential as excipients for the monthly sustained release risperidone PLGA microspheres due to higher encapsulation efficiency and almost zero-order release kinetics of release profile.

A naturalistic study of predictors and risks of atypical antipsychotic use in an attention-deficit/hyperactivity disorder clinic.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 575-82
Weiss M, Panagiotopoulos C, Giles L, Gibbins C, Kuzeljevic B, Davidson J, Harrison R
OBJECTIVE: This was an exploratory study to examine the use of atypical antipsychotics in an attention-deficit/hyperactivity disorder (ADHD) clinic. METHOD: A total of 194 patients was examined to compare those receiving atypical or second-generation antipsychotics (atypicals) from those who were not. A sample of 27 children on atypicals received laboratory investigation for indicators of possible metabolic effects. RESULTS: In all, 19.1% of the patients in the clinic were receiving atypicals with a mean duration of 313 days; 36 of 37 patients on atypicals had received risperidone, with a mean dose of 0.62 mg. Children receiving atypicals were statistically more likely to have a severe co-morbid disorder, a lower Children's Global Assessment Scale score, a greater total score on the teacher Strengths and Difficulties Questionnaire, and greater difficulty with parent-rated symptoms of being touchy, worried, rages, and explosive outbursts. There were no differences found in measures of functioning, adaptive skills, quality of life, or ADHD symptoms. In the subset of children studied for potential metabolic effects, 68.0% had a waist circumference > or =90(th) percentile that was independent of weight gain, 18.5% had impaired fasting glucose, 12.5% had elevated blood pressure, 11.1% had elevated triglycerides, and 16.7% met full criteria for metabolic syndrome. CONCLUSION: Clinical implementation of the efficacy studies of risperidone for disruptive behavior disorders has led to a significant change in practice. Almost 1 in 5 patients are now receiving atypical neuroleptics, typically to treat severe co-morbid disorders and symptoms other than ADHD per se. Despite these children receiving low doses, concomitant stimulants, and low body mass index z-scores, a significant proportion of children demonstrated either one or more components or the full criteria for metabolic syndrome.

Lack of effect of stimulant combination with second-generation antipsychotics on weight gain, metabolic changes, prolactin levels, and sedation in youth with clinically relevant aggression or oppositionality.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 563-73
Penzner JB, Dudas M, Saito E, Olshanskiy V, Parikh UH, Kapoor S, Chekuri R, Gadaleta D, Avedon J, Sheridan EM, Randell J, Malhotra AK, Kane JM, Correll CU
BACKGROUND: Second-generation antipsychotics (SGAs) are associated with weight gain, metabolic abnormalities, sedation/sleep disturbance, and prolactin abnormalities, especially in youths. Although stimulants have opposing dopamine receptor and adverse effects, it is unclear whether stimulant co-treatment counteracts the therapeutic or side effects of antipsychotics. METHODS: This was a naturalistic cohort study including 153 antipsychotic trials in youths aged 4-19 (mean, 11.3 +/- 3.0) years, started on an SGA for clinically significant aggression or oppositionality associated with oppositional defiant disorder, conduct disorder, disruptive behavior disorder not otherwise specified (NOS), impulse control disorder NOS, intermittent explosive disorder, Tourette's disorder, autistic disorder, and pervasive developmental disorder NOS. Patients underwent fasting assessments of body composition, lipids, glucose, insulin, prolactin, sedation, and general efficacy at baseline, weeks 4, 8, and 12, comparing patients co-prescribed stimulants (n = 71) with those not co-prescribed stimulants (n = 82). RESULTS: Patients received risperidone (33.3%), aripiprazole (29.4%), quetiapine (18.4%), olanzapine (11.8%), ziprasidone (5.9%), or clozapine (0.7%). With and without adjustment for differences in baseline variables (sex, prior stimulant use, primary Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition [DSM-IV] disorders, co-morbid attention-deficit/hyperactivity disorder [ADHD], present in 46.3% of youths not receiving stimulants, and some body composition parameters), patients on versus off stimulants did not differ on any of the assessed outcomes (all p values > or = 0.1). CONCLUSIONS: In contrast to guidelines, stimulant use did not precede or accompany antipsychotic use during the current episode of aggression/oppositionality in almost half of those youths who had aggressive/oppositional behavior and a DSM-IV diagnosis of ADHD. At the clinically prescribed doses, stimulant co-treatment of SGAs did not seem to significantly reduce antipsychotic effects on body composition, metabolic parameters, prolactin, sedation, and broad efficacy.

Effects of repeated risperidone exposure on serotonin receptor subtypes in developing rats.

Eur Neuropsychopharmacol. 2009 Oct 28;
Choi YK, Moran-Gates T, Gardner MP, Tarazi FI
Risperidone is an atypical antipsychotic drug that is widely prescribed to young patients with different psychotic disorders. The long-term effects of this antipsychotic agent on neuronal receptors in developing brain remain unclear and require further investigation. In this study, we examined the effects of long-term treatment of risperidone on two serotonin receptor subtypes in brain regions of juvenile rat. Levels of 5-HT(1A) and 5-HT(2A) receptors in forebrain regions of juvenile rats were quantified after 3weeks of treatment with three different doses of risperidone (0.3, 1.0 and 3.0mg/kg). Findings were compared to previously reported changes in 5-HT receptors after risperidone treatment (3.0mg/kg) in adult rat brain. The three doses of risperidone selectively and dose-dependently increased levels of 5-HT(1A) receptors in medial-prefrontal and dorsolateral-frontal cortices of juvenile animals. The higher doses (1.0 and 3.0mg/kg) of risperidone also increased 5-HT(1A) receptor binding in hippocampal CA(1) region of juvenile but not adult rats. In contrast, the three doses of risperidone significantly reduced 5-HT(2A) labeling in medial-prefrontal and dorsolateral-frontal cortices in juvenile as well as in adult animals in an equipotent fashion. 5-HT(1A) and 5-HT(2A) receptors in other forebrain regions were not altered by repeated risperidone treatment. These findings indicate that there are differential effects of risperidone on 5-HT(1A) and 5-HT(2A) receptors in juvenile animals, and that the 5-HT system in developing animals is more sensitive than adults to the long-term effects of risperidone.

Leptin gene -2548G/A variants predict risperidone-associated weight gain in children and adolescents.

Psychiatr Genet. 2009 Dec; 19(6): 320-7
Calarge CA, Ellingrod VL, Zimmerman B, Acion L, Sivitz WI, Schlechte JA
OBJECTIVE: As the use of atypical antipsychotics in children and adolescents has increased, concerns have been raised about their long-term safety. We aimed to investigate the association between risperidone-induced weight gain, leptin concentration, and the leptin gene (LEP) -2548G/A variants in youths. METHODS: Medically healthy 7- to 17-year-old children and adolescents, in extended naturalistic treatment with risperidone, were recruited through pediatric psychiatry clinics. Anthropometric measures and laboratory testing were conducted. Growth and medication history was obtained from the medical record. The effect of the LEP genotypes on leptin concentration and on the slopes of the weight and body mass index (BMI) Z-score curves before and after the onset of risperidone treatment was investigated .RESULTS: In 74 individuals, chronically treated with risperidone, the A allele was associated with higher leptin concentration at low weight and BMI Z-scores. There was no effect of the LEP genotypes on weight or BMI Z-scores before risperidone was started. Afterwards, however, the A-allele carriers showed a steeper rate of increase in weight and BMI Z-scores. As a result, the GG-genotype carriers were 2.5 times less likely to be overweight/obese (i.e. having a BMI above the 85th percentile). This genetic effect on risperidone-associated weight gain did not extend to weight loss related to psychostimulants. CONCLUSION: The LEP - 2548G/A variants seem to moderate the weight-altering effect of risperidone but not psychostimulants. This may be related to genetic differences in tissue sensitivity to leptin, resulting in differential body composition.

 

This page was last reviewed by Dr Greg Mulhauser, Monday, 1 June 2009.

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