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):

Abnormal laboratory values during the acute and recovery phases in schizophrenic patients: a retrospective study.

Neuropsychiatr Dis Treat. 2010; 6: 281-8
Nagamine T
During treatment of acute-phase schizophrenia, attention needs to be given to physical as well as psychological symptoms. It is often difficult, however, to obtain information on physical symptoms from patients with psychomotor excitation, and only laboratory examinations can provide objective data. The results of laboratory parameters measured in 68 patients with schizophrenia during psychomotor excitation and approximately 1 month later during the medicated recovery phase have been analyzed retrospectively. Abnormal laboratory values during psychomotor excitation were frequent. The most frequent (>/=35% of patients) were increased white blood cell count, low serum potassium levels, high levels of fasting blood sugar, lactate dehydrogenase and uric acid. There were fewer abnormal values during the medicated recovery phase. The most frequent (>/=25% of patients) were high serum levels of triglycerides, amylase, creatinine kinase, and low-density lipoprotein cholesterol. Abnormal triglyceride levels were found significantly more frequently in patients receiving olanzapine than those receiving risperidone. Abnormal values during the acute phase may be the result of excitation such as increased sympathetic tone and dehydration. Abnormal values during the recovery phase appeared to be related to the adverse metabolic effects of antipsychotic drugs. The frequency of these abnormal values was particularly high in patients receiving olanzapine alone or in combination with other medications.

Endocannabinoid Pro129Thr FAAH Functional Polymorphism But Not 1359G/A CNR1 Polymorphism Is Associated With Antipsychotic-Induced Weight Gain.

J Clin Psychopharmacol. 2010 Aug; 30(4): 441-5
Monteleone P, Milano W, Petrella C, Canestrelli B, Maj M
Several candidate genes have been associated with antipsychotic-induced body weight (BW) gain. Because the endocannabinoid system is deeply involved in BW regulation, endocannabinoid genes may have a role in the antipsychotic-induced weight gain. Therefore, we investigated the 1359 G/A (rs1049353) single nucleotide polymorphisms (SNP) of the cannabinoid receptor 1 (CNR1) gene, which codes the endocannabinoid CB1 receptor, and the complementary DNA (cDNA) 385C/A (rs324420) SNP of the FAAH gene, which codes the endocannabinoid degrading enzyme, for their role in BW changes induced by antipsychotic drugs. Eighty-three white psychotic patients who underwent a naturalistic treatment with different antipsychotics (clozapine, olanzapine, risperidone, quetiapine, and haloperidol) and completed a 24-week treatment period were included into the study together with 80 age- and sex-matched white healthy controls. At the 24th week of treatment, 41 patients gained more than 7% of their baseline BW. No significant differences between patients and controls emerged in genotype and allele frequencies of both SNPs. Genotype and allele frequencies of the FAAH cDNA 385C/A SNP but not of the CNR1 1359 G/A SNP significantly differed between subjects who gained more than 7% of BW and those who did not, with both AC and AA genotypes and the A allele being significantly more frequent in patients who gained more than 7% of their baseline BW. Present findings, although obtained in a small population and in a naturalistic setting, suggest that the cDNA 385C/A SNP of the FAAH gene may predispose subjects to get a clinically meaningful weight gain after antipsychotic exposure.

Risperidone overdose causes extrapyramidal effects but not cardiac toxicity.

J Clin Psychopharmacol. 2010 Aug; 30(4): 387-90
Page CB, Calver LA, Isbister GK
OBJECTIVE:: The aim of this study was to describe the clinical and electrocardiographic features of risperidone overdose, including the frequency of dystonic reactions. METHODS:: A consecutive series of admissions for risperidone overdose (>6 mg) were identified from a prospective database of poisoning admissions to a regional toxicology service. Data extracted included patient demographics, details of ingestion, clinical features including neurological findings and evidence of dystonias, electrocardiographic parameters (heart rate [HR], QRS, and QT intervals), complications, and medical outcomes including intensive care unit admission. In addition to descriptive statistics, visual inspection of plots of QT-HR pairs compared with the QT nomogram was performed. RESULTS:: There were 107 patients with 157 presentations, including 38 patients with 45 risperidone-alone overdoses. Of the 38 patients who ingested risperidone alone, the median age was 25 years (interquartile range [IQR],16-31 years), and 19 (50%) were female. The median dose ingested was 33 mg (IQR, 15-75 mg; range, 8-248 mg). Median length of stay was 16 hours (IQR, 8-18 hours), and none was ventilated or admitted to the intensive care unit. There were 5 cases (11%) with dystonic reactions, 26 (58%) with tachycardia (HR >/=100 beats/min), and no cases with hypotension (blood pressure

Long-acting injectable antipsychotics: focus on olanzapine pamoate.

Neuropsychiatr Dis Treat. 2010; 6: 261-7
Lindenmayer J
Medication non-adherence in patients with schizophrenia continues to be a significant problem and threatens successful treatment outcomes. Medication non-adherence is often associated with negative consequences, including symptom exacerbation, more frequent emergency room visits, re-hospitalizations and relapse. Long-acting injectable (LAI) forms of antipsychotics allow for rapid identification of non-adherence, obviate the need for the patient to take the medication on a daily basis and increase adherence to some significant degree. Eli Lilly has developed a long-acting depot formulation of olanzapine, olanzapine pamoate, which has recently been approved by the FDA for the US market, and which will be reviewed here. Olanzapine LAI appears to be an effective antipsychotic at dosages of 210 mg every 2 weeks, 300 mg every 2 weeks and 405 mg every 4 weeks in patients with acute schizophrenia, and at 150 mg every 2 weeks, 300 mg every 2 weeks and at 405 mg every 4 weeks for the maintenance treatment of stable patients. Oral supplementation appears not to be needed, particularly not at the onset of treatment with the LAI as is necessary with risperidone LAI. Its efficacy is in general comparable to the efficacy seen with oral olanzapine at a corresponding dose. The side effect profile is also comparable to the side effects observed with oral olanzapine, including lower rates of extrapyramidal symptoms, prolactin elevation and cardiovascular side effects, but significant metabolic effects. The latter include significant weight gain, lipid abnormalities and glucose dysregulation. While the injection site adverse events are overall mild, the most significant serious adverse event is the post-injection delirium sedation syndrome (PDSS). While rare, this syndrome results from inadvertent intravascular injection of olanzapine LAI and can cause a range of olanzapine overdose-type of symptoms. Olanzapine LAI needs therefore to be administered by trained personnel in settings where a post-injection observation period for at least 3 hours by medical personnel is available. The overall use of olanzapine LAI will probably be limited by the possibility of a PDSS event. Patients who have a history of good response to oral olanzapine and are in need of assured medication administration may present a good indication for its use, provided that the appropriate mental health delivery setting is available.

Treating Neuropsychiatric Symptoms in Dementia With Lewy Bodies: A Randomized Controlled-trial.

Alzheimer Dis Assoc Disord. 2010 Jul 9;
Culo S, Mulsant BH, Rosen J, Mazumdar S, Blakesley RE, Houck PR, Pollock BG
Sensitivity to psychotropic medications presents a therapeutic challenge when treating neuropsychiatric symptoms in patients with dementia with Lewy bodies (DLB). We compared under randomized, double-blinded conditions the tolerability and efficacy of citalopram and risperidone in the treatment of behavioral and psychotic symptoms in patients with DLB and Alzheimer disease (AD). Thirty-one participants with DLB and 66 with AD hospitalized for behavioral disturbance were treated under randomized, double-blind conditions with citalopram or risperidone for up to 12 weeks. Neuropsychiatric symptoms were assessed with the nursing home version of the Neuropsychiatric Inventory (NPI) and the Clinical Global Impression of Change (CGIC). Side effects were measured using the UKU Side Effect Rating Scale. A significantly higher proportion of participants with DLB (68%) than with AD (50%) discontinued the study prematurely. Discontinuation rates were comparable in DLB participants treated with citalopram (71%) or risperidone (65%). However, participants with DLB randomized to risperidone experienced a higher overall burden of side effects. Scores on the NPI and the CGIC worsened in DLB participants and improved in those with AD. Most patients with behavioral disturbances or psychosis associated with DLB tolerate citalopram or risperidone poorly and do not seem to benefit from either medication.

 

This page was last reviewed by Dr Greg Mulhauser, Tuesday, 11 May 2010.

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