Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new risperdal research articles will be listed here shortly after becoming available to us.
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Medical research on risperdal
CNS Drugs. 2008; 22(3): 259-62
Scott LJ, Dhillon S
Risperidone (Risperdal), a psychotropic atypical antipsychotic agent, is thought to act via dopamine D(2) and serotonin 5-HT(2A) receptor antagonism. The clinical efficacy of oral risperidone in the treatment of bipolar mania and schizophrenia in adult patients is well established. In the US, risperidone is also approved for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years, for the treatment of schizophrenia in adolescents aged 13-17 years and, as monotherapy, for the short-term treatment of acute manic and mixed episodes associated with bipolar I disorder in children and adolescents aged 10-17 years.Oral risperidone treatment was better than placebo treatment in reducing irritability and other behavioural symptoms associated with autistic disorder in children and adolescents in two well designed short-term trials, with these benefits maintained in those receiving risperidone for up to 6 months. The drug had a clinically manageable tolerability profile, with most adverse events being of mild to moderate intensity. There are some aspects of treatment, such as weight gain, somnolence and hyperglycaemia, that require monitoring, and the long-term safety of risperidone in children and adolescents with autistic disorder remains to be fully determined. With these issues in mind, risperidone offers a valuable emerging option for the treatment of irritability associated with autistic disorder in children and adolescents.
Paediatr Drugs. 2007; 9(5): 343-54
Scott LJ, Dhillon S
Risperidone (Risperdal), a psychotropic atypical antipsychotic agent, is thought to act via dopamine D(2) and serotonin (5-HT [5-hydroxytryptamine])(2A) receptor antagonism. The clinical efficacy of oral risperidone in the treatment of bipolar mania and schizophrenia in adult patients is well established. In the US, risperidone is also approved for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years, for the treatment of schizophrenia in adolescents aged 13-17 years and, as monotherapy, for the short-term treatment of acute manic and mixed episodes associated with bipolar I disorder in children and adolescents aged 10-17 years. Oral risperidone treatment was better than placebo treatment in reducing irritability and other behavioral symptoms associated with autistic disorder in children and adolescents in two well designed short-term trials, with these benefits maintained in those receiving risperidone for up to 6 months. The drug had a clinically manageable tolerability profile, with most adverse events being of mild to moderate intensity. There are some aspects of treatment, such as weight gain, somnolence, and hyperglycemia, that require monitoring, and the long-term safety of risperidone in children and adolescents with autistic disorder remains to be fully determined. With these issues in mind, risperidone offers a valuable emerging option for the treatment of irritability associated with autistic disorder in children and adolescents.
Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets.
Int J Clin Pharmacol Ther. 2007 May; 45(5): 293-9
van Os S, Relleke M, Piniella PM
Risperidone is an atypical anti-psychotic, available in various formulations. OBJECTIVE: The objective of the study was to compare the bioavailability of a generic oral solution of risperidone (Test formulation) and Risperdal tablets (Reference formulation). Both formulations contained 1 mg risperidone per dosing unit. METHODS: The study was carried out in 32 healthy volunteers under fasting conditions. Risperidone and 9-hydroxyrisperidone concentrations in plasma were determined using HPLC/MS/MS. RESULTS: The results show that the 90% confidence intervals for the geometric mean ratios of the solution and the tablet formulations were not within the acceptance range of 80 125% for risperidone, whereas the confidence intervals for 9-hydroxyrisperidone were within the acceptance range of 80 - 125%. CONCLUSION: Bioequivalence between the generic 1 mg/ml risperidone solution and the originator tablet formulation was not proven in this study.
Hum Psychopharmacol. 2007 Jul; 22(5): 307-14
Chue P, Prinzo RS, Binder CE
BACKGROUND: Orally disintegrating risperidone tablets (Risperdal* M-TABs*) present an alternative method of drug delivery that may benefit physicians struggling to treat non-compliant patients, since it begins to dissolve within 5 s, preventing tablet cheeking or spitting. OBJECTIVES: To evaluate safety and maintenance of effect in symptomatically stable patients transitioned from compressed risperidone tablets to orally disintegrating risperidone tablets. METHODS: This open-label, multi-centre study enrolled 82 adults from four diagnostic groups (major depressive disorder (MDD), n = 25; bipolar disorder (BP), n = 21; dementia (DE), n = 20; schizophrenia (SZ), n = 16). Patients were switched from their previous dosage of compressed tablets (0.5, 1.0, 2.0, 3.0, or 4.0 mg/day) to an equivalent dosage of orally disintegrating risperidone and followed for 4 weeks. The primary effectiveness parameter evaluated was the Clinical Global Impression-Severity (CGI-S) scale. RESULTS: Most patients (24/25 MDD; 20/21 BP; 17/18 DE; 14/15 SZ) improved by 1 point on CGI-S from baseline or experienced no change at endpoint. Adverse events (AEs) occurring in any group at a > or =10% incidence included headache (19%) and pharyngolaryngeal pain (10%), reported in the BP group only. CONCLUSIONS: Patients stabilized on compressed risperidone tablets transitioned to the equivalent dose of orally disintegrating risperidone tablets with continued maintenance of effect, no decompensation and with minimal side effects.
Cochrane Database Syst Rev. 2007; CD005594
Lonergan E, Britton AM, Luxenberg J, Wyller T
BACKGROUND: Delirium occurs in up to 30% of hospitalised patients and is associated with prolonged hospital stay and increased morbidity and mortality. Recently published reports have suggested that the standard drug for delirium, haloperidol, a typical antipsychotic that may cause adverse extrapyramidal symptoms among patients, may be replaced by atypical antipsychotics such as risperidone, olanzapine or quetiapine, that are as effective as haloperidol in controlling delirium, but that have a lower incidence of extrapyramidal adverse effects. OBJECTIVES: To compare the efficacy and incidence of adverse effects of haloperidol with risperidone, olanzapine, and quetiapine in the treatment of delirium. SEARCH STRATEGY: The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 7 August 2006 using the search terms:haloperidol or haldol or risperidone or risperdal* or quetiapine or seroquel* or olanzapine or zyprexa* or aminotriazole or sertindole or leponex* or zeldox* or ziprasidone. SELECTION CRITERIA: Types of studies included unconfounded, randomised trials with concealed allocation of subjects. For inclusion trials had to have assessed patients pre- and post-treatment. Where cross-over studies are included, only data from the first part of the study were examined. Interrupted time series were excluded. Length of trial and number of measurements did not influence the selection of trials for study. Where indicated, individual patient data were requested for further examination. DATA COLLECTION AND ANALYSIS: Two reviewers extracted data from included trials. Data were pooled where possible, and analysed using appropriate statistical methods. Odds ratios of average differences were calculated. Only 'intention to treat' data were included. Analysis included haloperidol treated patients, compared with placebo. MAIN RESULTS: Three studies were found that satisfied selection criteria. These studies compared haloperidol with risperidone, olanzapine, and placebo in the management of delirium and in the incidence of adverse drug reactions. Decrease in delirium scores were not significantly different comparing the effect of low dose haloperidol (< 3.0 mg per day) with the atypical antipsychotics olanzapine and risperidone (Odds ratio 0.63 (95% CI 10.29 - 1.38; p = 0.25). Low dose haloperidol did not have a higher incidence of adverse effects than the atypical antipsychotics. High dose haloperidol (> 4.5 mg per day) in one study was associated with an increased incidence of extrapyramidal adverse effects, compared with olanzapine. Low dose haloperidol decreased the severity and duration of delirium in post-operative patients, although not the incidence of delirium, compared to placebo controls in one study. There were no controlled trials comparing quetiapine with haloperidol. AUTHORS' CONCLUSIONS: There is no evidence that haloperidol in low dosage has different efficacy in comparison with the atypical antipsychotics olanzapine and risperidone in the management of delirium or has a greater frequency of adverse drug effects than these drugs. High dose haloperidol was associated with a greater incidence of side effects, mainly parkinsonism, than the atypical antipsychotics. Low dose haloperidol may be effective in decreasing the degree and duration of delirium in post-operative patients, compared with placebo.These conclusions must be tempered by the observation that they are based on small studies of limited scope, and therefore will require further corroborating evidence before they can be translated into specific recommendation for the treatment of delirium.
Risperidone alone or in combination for acute mania.
Cochrane Database Syst Rev. 2006; CD004043
Rendell JM, Gijsman HJ, Bauer MS, Goodwin GM, Geddes GR
BACKGROUND: Risperidone, an atypical antipsychotic, is used to treat mania both alone and in combination with other medicines. OBJECTIVES: To review the efficacy and tolerability of risperidone as treatment for mania. SEARCH STRATEGY: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR-Studies December 2004), The Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, MEDLINE, CINAHL and PsycINFO were searched in December 2004. Reference lists and English language textbooks were searched; researchers in the field and Janssen-Cilag were contacted. SELECTION CRITERIA: Randomised controlled trials comparing risperidone with placebo or other drugs in acute manic or mixed episodes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data from trial reports. Janssen-Cilag was asked to provide missing information. QUALITY ASSESSMENT: As in other trials of treatment for mania, the high proportion of imputed efficacy data resulting from rates of failure to complete treatment of between 12% and 62% may have biased the results. MAIN RESULTS: Six trials (1343 participants) of risperidone as monotherapy or as adjunctive treatment to lithium, or an anticonvulsant, were identified. Permitted doses were consistent with those recommended by the manufacturers of Haldol (haloperidol) and Risperdal (risperidone) for treatment of mania and trials involving haloperidol allowed antiparkinsonian treatment. Risperidone monotherapy was more effective than placebo in reducing manic symptoms, using the Young Mania Rating Scale (YMRS) (weighted mean difference (WMD) -5.75, 95% confidence interval (CI) -7.46 to -4.04, P
Treatment of comorbidity in conduct disorder with attention-deficit hyperactivity disorder (ADHD).
Essent Psychopharmacol. 2005; 6(5): 277-90
Turgay A
Conduct disorder (CD) is one of the most common psychiatric disorders in childhood and adolescence. It is characterized by a variety of chronic antisocial behaviors, a repetitive and persistent pattern of behavior that violates the basic rights of others, major age-appropriate societal norms, or both. Aggressive behavior, lying, stealing, fire-setting, and running away from home and school are the most frequent manifestations of CD and are often accompanied by hyperactivity, impulsive behavior, explosiveness, cognitive and learning problems, and poor social skills. The rate of comorbidity is high, with attention-deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) being the most common; comorbid anxiety and depressive disorders are also seen, especially in adolescents. The diagnostic process should include the use of structured interviews, and scores from reliable and valid rating scales that cover all psychiatric disorders must be considered in the differential diagnosis, because CD alone is an extreme rarity and multiple disorders are almost always the rule rather than exception. Treatment should include parenting skills training combined with training of the child to improve his or her relationships with peers, academic performance, and compliance with legitimate demands of authority figures. The appropriate use of medications and integration of patient/parent education and support, as well as individual, group, family, residential, and inpatient treatment may be beneficial for patients with CD and ADHD. The article describes a number of psychopharmacological agents that are used in patients with CD with ADHD and other comorbid disorders. Drugs that may be useful include psychostimulants; atomoxetine (Strattera); antidepressants (imipramine [Tofranil], desipramine [Norpramin]); Selective Serotonin Reuptake Inhibitors (SSRIs); atypical antipsychotics such as risperidone (Risperdal); or mood regulators including lithium (Eskalith).
Neuropsychopharmacology. 2006 Jul; 31(7): 1420-30
Dickerson J, Sharp FR
Noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonists such as phencyclidine, ketamine, and MK-801 produce schizophrenia-like psychosis in humans. The same NMDA antagonists injure retrosplenial cortical neurons in adult rats. We examined the effects of atypical antipsychotics and an inhibitor of nonreceptor tyrosine kinase pp60 (Src) on the cortical injury produced by MK-801. An atypical antipsychotic (either clozapine, ziprasidone, olanzapine, quetiapine, or risperidone) or vehicle was administered to adult female Sprague-Dawley rats. PP1 (Src inhibitor), PP3 (nonfunctional analog of PP1) or vehicle (DMSO) was administered to another group of animals. After pretreatment, animals were injected with MK-801, killed 24 h after the MK-801, and injury to retrosplenial cortex assessed by neuronal Hsp70 protein expression. All atypical antipsychotics examined significantly attenuated MK-801-induced cortical damage. PP1 protected compared to vehicle, whereas PP3 did not protect. The ED50s (decrease injury by 50%) were as follows: PP1
Risperidone (Risperdal): clinical experience with a new antipsychosis drug.
Expert Opin Investig Drugs. 1999 Apr; 8(4): 443-52
Keks NA, Culhane C
Risperidone (Risperdal) is a benzisoxazole derivative with a high affinity for serotonin 5-HT2 and dopamine D2 receptors, and some affinity for alpha- adrenergic, histamine H1 and dopamine D1 receptors. It has no anticholinergic effects. Early studies demonstrated risperidone to be an effective medication for psychotic symptoms, probably more so than the older neuroleptics for both positive and negative symptoms. At clinically effective doses, risperidone causes no more extrapyramidal side-effects (EPS) than placebo; at higher doses EPS frequency increases in a dose-dependent manner. Since it became available in 1994, extensive experience with the drug supports favourable early impressions of efficacy and tolerability. Minimal sedation, relatively little weight gain and absence of anticholinergic manifestations contribute to the relative tolerability of risperidone as compared to older neuroleptics. However, risperidone is associated with hyperprolactinaemia which can result in amenorrhoea and sexual dysfunction. Compared to older neuroleptics, pharmacoeconomic studies have shown that use of risperidone is associated with reduced hospitalisation and direct cost savings. A recent study found equivalent efficacy between risperidone and clozapine for treatment-resistant patients. Two studies comparing risperidone and olanzapine have yielded positive but conflicting findings. The overall positive experience with risperidone has resulted in the drug being widely recommended as a first line treatment option for psychoses.
Int Clin Psychopharmacol. 2005 Jul; 20(4): 213-21
Lindenmayer JP, Jarboe K, Bossie CA, Zhu Y, Mehnert A, Lasser R
Long-acting injectable antipsychotic formulations of conventional antipsychotics were developed to address the problem of partial adherence among patients with schizophrenia. Injection site pain, other skin reactions and patient satisfaction with treatment were assessed in two large, multicentre studies of long-acting injectable risperidone (Risperdal CONSTA, Janssen Pharmaceutica Products, Titusville, New Jersey, USA), the first available long-acting atypical antipsychotic agent. Patients rated injection site pain using a 100-mm Visual Analogue Scale (VAS), and investigators rated injection site pain, redness, swelling and induration. Patient satisfaction with treatment was assessed with the Drug Attitude Inventory (DAI). VAS pain ratings were low at all visits across all doses in both studies, and decreased from first to final injection. In the 12-week, double-blind study, mean +/- SD VAS scores at the first and final injections were 15.6 +/- 20.7 and 12.5 +/- 18.3 for placebo-treated patients, and 11.8 +/- 14.4 (first) and 10.0 +/- 12.4 (final) for 25 mg; 16.3+/-21.9 (first) and 13.6 +/- 21.7 (final) for 50 mg; and 16.0 +/- 17.9 (first) and 9.6 +/- 16.0 (final, P