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):

Novel and emerging treatments for autism spectrum disorders: a systematic review.

Ann Clin Psychiatry. 2009 Oct-Dec; 21(4): 213-36
Rossignol DA
BACKGROUND: Currently, only one medication (risperidone) is FDA-approved for the treatment of autism spectrum disorders (ASD). Perhaps for this reason, the use of novel, unconventional, and off-label treatments for ASD is common, with up to 74% of children with ASD using these treatments; however, treating physicians are often unaware of this usage. METHODS: A systematic literature search of electronic scientific databases was performed to identify studies of novel and emerging treatments for ASD, including nutritional supplements, diets, medications, and nonbiological treatments. A grade of recommendation ("Grade") was then assigned to each treatment using a validated evidence-based guideline as outlined in this review: A: Supported by at least 2 prospective randomized controlled trials (RCTs) or 1 systematic review. B: Supported by at least 1 prospective RCT or 2 nonrandomized controlled trials. C: Supported by at least 1 nonrandomized controlled trial or 2 case series. D: Troublingly inconsistent or inconclusive studies or studies reporting no improvements. Potential adverse effects for each treatment were also reviewed. RESULTS: Grade A treatments for ASD include melatonin, acetylcholinesterase inhibitors, naltrexone, and music therapy. Grade B treatments include carnitine, tetrahydrobiopterin, vitamin C, alpha-2 adrenergic agonists, hyperbaric oxygen treatment, immunomodulation and anti-inflammatory treatments, oxytocin, and vision therapy. Grade C treatments for ASD include carnosine, multivitamin/mineral complex, piracetam, polyunsaturated fatty acids, vitamin B6/magnesium, elimination diets, chelation, cyproheptadine, famotidine, glutamate antagonists, acupuncture, auditory integration training, massage, and neurofeedback. CONCLUSIONS: The reviewed treatments for ASD are commonly used, and some are supported by prospective RCTs. Promising treatments include melatonin, antioxidants, acetylcholinesterase inhibitors, naltrexone, and music therapy. All of the reviewed treatments are currently considered off-label for ASD (ie, not FDA-approved) and some have adverse effects. Further studies exploring these treatments are needed. Physicians treating children with an ASD should make it standard practice to inquire about each child's possible use of these types of treatments.

The effect of chronic antipsychotic drug administration on nitric oxide synthase activity and gene expression in rat penile tissues.

Eur Neuropsychopharmacol. 2009 Nov 13;
Zhang XR, Zhang ZJ, Jenkins TA, Cheng WR, Reynolds GP
Antipsychotic drug treatment may be associated with common and problematic sexual dysfunction, especially impotence, which can diminish quality of life and lead to treatment noncompliance. Nitric oxide synthase (NOS) is an important cellular modulator of erectile function. We have therefore investigated the effect of antipsychotic drug on activity and gene expression of NOS in rat penile tissues. The activity of constitutive NOS was significantly suppressed below control by a 21days administration of 1mg/kg haloperidol, which also significantly decreased expression of endothelial NOS (eNOS) and neural NOS mRNA. Risperidone at 0.5mg/kg also reduced eNOS mRNA expression. Haloperidol or risperidone did not change gene expression and activity of inducible NOS (iNOS). Quetiapine significantly increased activity and mRNA expression of iNOS with 20 and 40mg/kg doses. These preliminary results have important implications for enhancing our understanding of mechanisms by which antipsychotic drugs induce sexual dysfunction.

Weight gain, obesity, and metabolic indices following a first manic episode: Prospective 12-month data from the Systematic Treatment Optimization Program for Early Mania (STOP-EM).

J Affect Disord. 2009 Nov 13;
Bond DJ, Kauer-Sant'anna M, Lam RW, Yatham LN
BACKGROUND: Numerous studies have demonstrated an association between bipolar disorder (BD) and obesity. However, these reports are limited by retrospective or cross-sectional designs, and the assessment of patients with lengthy illnesses. Prospective data, and data on weight gain early in the course of BD, are lacking. METHODS: We prospectively measured weight gain and laboratory metabolic indices over 12months in 47 patients with BD receiving maintenance treatment following their first manic episode, and in 24 age- and gender-matched healthy subjects. RESULTS: Although approximately two-thirds of patients had experienced previous depressive or hypomanic episodes, there was no difference between patients and healthy subjects in mean body mass index or rates of overweight or obesity at recovery from the first mania. Mean weight gain over 12months was 4.76kg in patients and 1.50kg in healthy subjects (p=0.047). Combined rates of overweight and obesity at 6months and 12months exceeded 50% in patients, and were almost double those of healthy subjects. Logistic regression demonstrated that weight gain in the first 6months was significantly associated with male gender and prescription of olanzapine or risperidone. Patients who were obese at 6months and/or 12months had significantly greater mean serum triglyceride levels and fasting glucose levels than non-obese patients. LIMITATIONS: This was a naturalistic study. CONCLUSIONS: Even in patients with previous depressions and hypomanias, clinically significant weight gain in BD begins following the first manic episode, suggesting that it is primarily related to treatment with mood stabilizers and second-generation antipsychotics. However, the very small number of patients in our sample who were medication-free precludes a meaningful analysis of the degree to which weight gain might be an inherent feature of post-manic BD.

Effect Of Pretreatment With Risperidone On Phencyclidine-Induced Disruptions In Object Recognition Memory And Prefrontal Cortex Parvalbumin Immunoreactivity In The Rat.

Behav Brain Res. 2009 Nov 12;
McKibben CE, Jenkins TA, Adams HN, Harte MK, Reynolds GP
Sub-chronic administration of phencyclidine to the rat induces enduring cognitive and pathophysiological changes that resemble some features of schizophrenia. The present study aimed to determine if concurrent administration of the atypical antipsychotic, risperidone, could attenuate the effect of phencyclidine on object recognition memory and parvalbumin-containing neurons in the prefrontal cortex. Rats were administered phencyclidine at a dose of 2mg/kg i.p. bi-daily for one week, or vehicle. Half of the phencyclidine group was concurrently treated with risperidone (0.5mg/kg i.p) twice daily for ten days, beginning three days before the start of phencyclidine administration. Novel object recognition memory and subsequent brain analysis were assessed 6 weeks post phencyclidine treatment. Phencyclidine produced a deficit in object recognition memory as measured by the discrimination ratio. In addition, 6 weeks post-phencyclidine, analysis of brains showed a reduction in expression of parvalbumin immunoreactive neurons in the prefrontal cortex, with specific deficits observed in the prelimbic region, but not infralimbic or cingulate cortices. Concurrent administration of risperidone showed no protective effects against these deficits. These results show the importance of the sub-chronic phencyclidine rat in modelling cognitive and prefrontal pathophysiology observed in schizophrenia, but suggest that concurrent risperidone is not neuroprotective in this model.

Predictive familial risk factors and pharmacological responses in ADHD with co-morbid DBDs.

Pediatr Int. 2009 Nov 13;
Bandou N, Koike K, Matuura H
Abstract Background: To examine the putative familial risk factors and evaluate the pharmacological effects in children and adolescents of attention-deficit/hyperactivity disorder (ADHD) with co-morbid disruptive behavior disorders (DBDs) and normal IQ. Methods: Our retrospective study included 144 Japanese subjects (ages 5-18 years) with ADHD, of whom 35 subjects (24%) met the diagnostic criteria for DBDs. Using multiple regression analysis, we assessed the familial background risk factors that might increase any co-morbid antisocial behaviors. Furthermore, the 20 methylphenidate (MPH)-resistant DBDs subjects were divided into three treatment groups: MPH plus risperidone (n = 8); MPH plus carbamazepine (n = 5); MPH plus lithium carbonate (n = 4). We evaluated the effectiveness of the treatment both before and after the add-on therapy using the Clinical Global Impressions-Improvement (CGI-I) and CGI-Severity (CGI-S) scale. Results: The putative familial risk factors were child abuse (odds ratio [OR]= 19.48, p = .013) and maternal psychiatric disorders (OR = 15.59, p = .027). The addition of risperidone showed the strongest tendency to improve the CGI-S scale (p = .063) and the highest rate of responses (50%) among the three treatment groups, albeit with no significant differences. Very few remarkable adverse clinical symptoms were observed. Conclusions: Child abuse and maternal psychiatric disorders are suggested to be significant risk factors in influencing the development of co-morbid DBDs in offspring. The use of risperidone appears to be well tolerated and is moderately effective with MPH-resistant aggression in ADHD children and adolescents with co-morbid DBDs.

 

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

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