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Fred Grossman - One of the best experts on this subject based on the ideXlab platform.
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acute and continuation Risperidone monotherapy in bipolar mania a 3 week placebo controlled trial followed by a 9 week double blind trial of Risperidone and haloperidol
European Neuropsychopharmacology, 2005Co-Authors: Anatoly B Smulevich, Mariëlle Eerdekens, Michelle Kramer, Sumant Khanna, Keith Karcher, Fred GrossmanAbstract:In a randomized, double-blind trial, patients with acute bipolar mania received 1-6 mg/day of Risperidone, 2-12 mg/day of haloperidol, or placebo for 3 weeks, followed by double-blind Risperidone or haloperidol for 9 weeks. Of 438 patients, 154 were randomized to Risperidone, 144 to haloperidol, and 140 to placebo. The mean+/-S.D. modal doses were 4.2+/-1.7 mg/day of Risperidone and 8.0+/-3.6 mg/day of haloperidol during the initial 3-week phase and 4.1+/-1.8 and 7.4+/-3.7 mg/day during the 12-week period. At week 3, mean Young Mania Rating Scale (YMRS) score reductions from baseline were significantly greater in patients receiving Risperidone than placebo (p<0.001). Differences between Risperidone and haloperidol on this efficacy measure were not significant. Further reductions in YMRS scores were seen in patients receiving Risperidone or haloperidol during the subsequent 9 weeks. No unexpected adverse events were reported. Extrapyramidal disorder and hyperkinesias, the most commonly reported adverse events with antipsychotic use, occurred less frequently with Risperidone than haloperidol. We conclude that Risperidone monotherapy was an effective and well-tolerated treatment for bipolar mania and that efficacy was maintained over the long term.
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a randomized placebo controlled trial of Risperidone for the treatment of aggression agitation and psychosis of dementia
The Journal of Clinical Psychiatry, 2003Co-Authors: Henry Brodaty, David Ames, John Snowdon, Michael Woodward, Jeff Kirwan, Roger Clarnette, Emma Lee, Ben Lyons, Fred GrossmanAbstract:BACKGROUND This randomized, double-blind, placebo-controlled trial examined the efficacy and safety of Risperidone in the treatment of aggression, agitation, and psychosis in elderly nursing-home patients with dementia. METHOD Elderly patients with a DSM-IV diagnosis of dementia of the Alzheimer's type, vascular dementia, or a combination of the 2 (i.e., mixed dementia) and significant aggressive behaviors were randomized to receive, for a period of 12 weeks, a flexible dose of either placebo or Risperidone solution up to a maximum of 2 mg/day. Outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale, and the Clinical Global Impression of Severity (CGI-S) and of Change (CGI-C) scales. RESULTS A total of 345 patients were randomized to treatment with Risperidone or placebo, and 337 patients received at least one dose of study drug. The trial was completed by 67% of patients in the placebo group and 73% of patients in the Risperidone group. The mean +/- SE dose of Risperidone was 0.95 +/- 0.03 mg/day. The primary endpoint of the study, the difference from baseline to endpoint in CMAI total aggression score, showed a significant reduction in aggressive behavior for Risperidone versus placebo (p <.001). A similar improvement was also seen for the CMAI total non-aggression subscale (p <.002) and for the BEHAVE-AD total (p <.001) and psychotic symptoms subscale (p =.004). At endpoint, the CGI-S and the CGI-C scores indicated a significantly greater improvement with Risperidone compared with placebo (p <.001). Overall, 94% and 92% of the Risperidone and placebo groups, respectively, reported at least 1 adverse event. Somnolence and urinary tract infection were more common with Risperidone treatment, whereas agitation was more common with placebo. There was no significant difference in the number of patients who reported extrapyramidal symptoms between the Risperidone (23%) and placebo (16%) groups. CONCLUSION Treatment with low-dose (mean = 0.95 mg/day) Risperidone resulted in significant improvement in aggression, agitation, and psychosis associated with dementia.
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mood stabilisers plus Risperidone or placebo in the treatment of acute mania international double blind randomised controlled trial
British Journal of Psychiatry, 2003Co-Authors: Laksami N Yatham, Fred Grossman, Ilse Augustyns, Eduard Vieta, Arun RavindranAbstract:Background Few double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania. Aims To determine the efficacy of Risperidone in combination with a mood stabiliser in acute mania. Method Patients taking a mood stabiliser were randomised to 3 weeks' treatment with Risperidone ( n =75) or placebo ( n =76). Results Young Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week 1 in the Risperidone group compared with the placebo group. At end-point YMRS scores decreased by 14.5 and 10.3 points in the Risperidone and placebo groups, respectively. Significant improvements v. placebo ( P <0.05) were noted in the Risperidone group on several other clinically meaningful measures. Additionally, a post hoc analysis excluding carbamazepine-treated patients (plasma concentrations of Risperidone active moiety were 40% lower in this group) revealed significantly greater reductions ( P =0.047) in YMRS scores in the Risperidone group than in the placebo group. Incidence of adverse events was similar in both groups. Conclusions Risperidone is superior to placebo when used in combination with lithium or divalproex in acute mania.
Christopher J Mcdougle - One of the best experts on this subject based on the ideXlab platform.
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effects of short and long term Risperidone treatment on prolactin levels in children with autism
Biological Psychiatry, 2007Co-Authors: George M Anderson, Christopher J Mcdougle, James T Mccracken, Lawrence Scahill, Michael G Aman, Elaine Tierney, Eugene L Arnold, Andres Martin, Liliya Katsovich, David J PoseyAbstract:Background The effects of short- and long-term Risperidone treatment on serum prolactin were assessed in children and adolescents with autism. Methods Patients with autism ( N = 101, 5–17 years of age) were randomized to an 8-week trial of Risperidone or placebo and 63 then took part in a 4-month open-label follow-up phase. Serum samples were obtained at Baseline and Week-8 ( N = 78), and at 6-month ( N = 43) and 22-month ( N = 30) follow-up. Serum prolactin was determined by immunoradiometric assay; dopamine type-2 receptor (DRD2) polymorphisms were genotyped. Results Baseline prolactin levels were similar in the Risperidone ( N = 42) and placebo ( N = 36) groups (9.3 ± 7.5 and 9.3 ± 7.6 ng/ml, respectively). After 8 weeks of Risperidone, prolactin increased to 39.0 ± 19.2 ng/ml, compared with 10.1 ± 8.8 ng/ml for placebo ( p N = 43, p N = 30, 25.3 ± 15.6 ng/ml, p Conclusions Risperidone treatment was associated with two- to four-fold mean increases in serum prolactin in children with autism. Although Risperidone-induced increases tended to diminish with time, further research on the consequences of long-term prolactin elevations in children and adolescents is needed.
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research units on pediatric psychopharmacology rupp autism network background and rationale for an initial controlled study of Risperidone
Child and Adolescent Psychiatric Clinics of North America, 2000Co-Authors: Christopher J Mcdougle, L Scahill, James T Mccracken, M G Aman, E Tierney, L E Arnold, B J Freeman, A Martin, J J Mcgough, P CroninAbstract:This article reviews the background and rationale for the choice of the atypical antipsychotic agent Risperidone as the first drug to be studied by the RUPP Autism Network. Risperidone has potent effects on serotonin and dopamine neuronal systems, which have been implicated in the pathophysiology of autism. Unlike typical antipsychotics, such as haloperidol and pimozide, which have been shown to be effective for reducing many of the maladaptive behaviors associated with autism, the unique ratio of serotonin to dopamine receptor blockade for Risperidone seems to produce a lower risk of acute and chronic extrapyramidial side effects and enhanced efficacy for the negative symptoms of autism. Indirect clinical and preclinical evidence supporting the use of Risperidone to treat impaired social behaviour, interfering repetitive phenomena and aggressions as targets of pharmacotherapy for patients with autism are reviewed. The safety and tolerability of Risperidone also are summarized.
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a double blind placebo controlled study of Risperidone in adults with autistic disorder and other pervasive developmental disorders
Archives of General Psychiatry, 1998Co-Authors: Christopher J Mcdougle, Janice P Holmes, Derek C Carlson, Gregory H Pelton, Donald J Cohen, Lawrence H PriceAbstract:Background Neurobiological research has implicated the dopamine and serotonin systems in the pathogenesis of autism. Open-label reports suggest that the serotonin 2A –dopamine D 2 antagonist Risperidone may be safe and effective in reducing the interfering symptoms of patients with autism. Methods Thirty-one adults (age [mean+SD], 28.1±7.3 years) with autistic disorder (n=17) or pervasive developmental disorder not otherwise specified (n=14) participated in a 12-week double-blind, placebo-controlled trial of Risperidone. Patients treated with placebo subsequently received a 12-week open-label trial of Risperidone. Results For persons completing the study, 8 (57%) of 14 patients treated with Risperidone were categorized as responders (daily dose [mean ± SD], 2.9±1.4 mg) compared with none of 16 in the placebo group ( P P P P P P P Conclusion Risperidone is more effective than placebo in the short-term treatment of symptoms of autism in adults.
Vivek Kusumakar - One of the best experts on this subject based on the ideXlab platform.
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Risperidone long acting injectable monotherapy in the maintenance treatment of bipolar i disorder
Biological Psychiatry, 2010Co-Authors: Jorge A Quiroz, Stuart Kushner, Keith Karcher, Lakshmi N Yatham, Joseph Palumbo, Vivek KusumakarAbstract:Background Treatment adherence is a significant problem in patients with bipolar disorder. This study was designed to determine the efficacy of Risperidone long-acting injectable (LAI) in the maintenance treatment of bipolar I disorder. Methods Eligible patients with current or recent manic or mixed episodes ( n = 559, aged 18–65 years) were treated with open-label oral Risperidone for 3 weeks (period II) and open-label Risperidone LAI for 26 weeks ( n = 501; period III). Patients who maintained response ( n = 303) were randomly allocated 1:1 to placebo injections ( n = 149) or to continue Risperidone LAI ( n = 154) for up to 24 months (period IV). Results Most (77%) patients on Risperidone LAI received a dose of 25 mg every 2 weeks during period IV. Time to recurrence for any mood episode (primary outcome variable) was significantly longer in the Risperidone LAI group versus placebo ( p p p = .805). Weight gains ≥7% (compared with the period's baseline) occurred in 15% of patients in period III; in 12% of patients on Risperidone LAI and 3% of patients on placebo in period IV. Conclusions Risperidone LAI monotherapy significantly delayed the time to recurrence of mood episodes, versus placebo, in this controlled, randomized study in patients with bipolar I disorder. Risperidone LAI was tolerable and no new safety concerns emerged compared with previous studies of Risperidone LAI.
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Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder a randomized double blind placebo controlled study
Bipolar Disorders, 2009Co-Authors: Magali Haas, Stuart Kushner, Ilse Augustyns, Melissa P Delbello, Gahan J Pandina, Ilse Van Hove, Jorge A Quiroz, Vivek KusumakarAbstract:Objectives: To evaluate the efficacy, safety, and tolerability of Risperidone monotherapy for the treatment of an acute mixed or manic episode in children and adolescents with bipolar I disorder. Methods: This randomized, placebo-controlled, double-blind, 3-arm study (N = 169) included children and adolescents (ages 10–17 years) with a DSM-IV diagnosis of bipolar I disorder, experiencing a manic or mixed episode. Study participants were randomized to placebo (n = 58), Risperidone 0.5–2.5 mg/day (n = 50), or Risperidone 3–6 mg/day (n = 61) for 3 weeks. The primary efficacy measure was change in Young Mania Rating Scale (YMRS) total score from baseline to end point. Safety assessments included adverse event (AE) monitoring and scores on extrapyramidal symptom rating scales. Results: Improvement in mean YMRS total score was significantly greater in Risperidone-treated subjects than in placebo-treated subjects [mean change (SD) −9.1 (11.0) for placebo; −18.5 (9.7) for Risperidone 0.5–2.5 mg (p < 0.001); −16.5 (10.3) for Risperidone 3–6 mg (p < 0.001)]. The most common Risperidone-associated AEs were somnolence, headache, and fatigue. Mean (SD) weight gain was 0.7 (1.9) kg, 1.9 (1.7) kg, and 1.4 (2.4) kg in the placebo, Risperidone 0.5–2.5 mg, and Risperidone 3–6 mg groups, respectively, during this 3-week study. Conclusions: At daily doses of 0.5–2.5 mg and 3–6 mg, Risperidone was effective and well tolerated in children and adolescents experiencing acute manic or mixed episodes of bipolar I disorder. Results indicate that Risperidone 0.5–2.5 mg has a better benefit–risk profile than Risperidone 3–6 mg.
Jun Nakamura - One of the best experts on this subject based on the ideXlab platform.
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addition of Risperidone to sertraline improves sertraline resistant refractory depression without influencing plasma concentrations of sertraline and desmethylsertraline
Human Psychopharmacology-clinical and Experimental, 2008Co-Authors: Reiji Yoshimura, Nobuhisa Ueda, Wakako Umenenakano, Atsuko Ikenouchisugita, Hikaru Hori, Jun NakamuraAbstract:In the present study, we examined the efficacy of Risperidone addition on sertraline-resistant depressed patients and the effects of Risperidone on the metabolism of sertraline. Ten patients (M/F: 4/6, age: 54 +/- 10 years) met the DSM-IV criteria for major depressive disorder enrolled the study. Hamilton Dating Scale for Depression (HAM-D) scores (mean +/- SD) in all 10 patients significantly decreased from 19 +/- 4 (before Risperidone addition) to 11 +/- 3 (4 weeks after Risperidone addition). Plasma levels of sertraline and desmethylsertraline did not change after Risperidone addition. Serum BDNF levels in responders to Risperidone addition were changed from 8.1 +/- 2.7 ng/ml (before Risperidone addition) to 11.5 +/- 0.9 ng/ml (4 weeks after Risperidone addition); in contrast, those in nonresponders changed from 7.8 +/- 2.2 ng/ml (before Risperidone addition) to 7.9 +/- 2.4 ng/ml (4 weeks after Risperidone addition). These results suggest that the addition of Risperidone to sertraline is effective and well tolerated for sertraline-resistant depressive patients, which is accompanied with the increase in serum BDNF levels in responders to the Risperidone addition, and the addition of Risperidone to sertraline does not seem to influence sertraline metabolism.
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little effects of low dosage of levomepromazine on plasma Risperidone levels
Pharmacopsychiatry, 2005Co-Authors: Reiji Yoshimura, Koji Shinkai, Shingo Kakihara, Makiko Goto, Yasuhisa Yamada, Kyoko Kaji, Nobuhisa Ueda, Jun NakamuraAbstract:: In the present study, we investigated the effects of levomepromazine on plasma Risperidone concentrations in a steady state. Twenty patients taking Risperidone at a stable dose for more than 2 weeks who were considered to require levomepromazine coadministration were selected. The scores of excitement in BPRS significantly decreased 2 weeks after the coadministration of levomepromazine. Plasma Risperidone concentrations and the ratio of Risperidone and 9-hydroxyRisperidone (Risperidone/9-hydroxyRisperidone) did not change between before and 2 weeks after the coadministration of levomepromazine. The extrapyramidal symptoms were not worsened by the coadministration of levomepromazine. These results suggest that a low dosage of levomepromazine, use as a sedative adjuvant to Risperidone treatment, have no statistically significant effect on the trough plasma concentrations of Risperidone.
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plasma levels of homovanillic acid and the response to Risperidone in first episode untreated acute schizophrenia
International Clinical Psychopharmacology, 2003Co-Authors: Reiji Yoshimura, Koji Shinkai, Nobuhisa Ueda, Jun NakamuraAbstract:We have previously reported that Risperidone might improve negative symptoms in schizophrenia by influencing noradrenergic neurons. In the present study, we focused on the clinical efficacy and mechanisms of Risperidone towards positive symptoms in the acute phase of schizophrenia. Thirty-four patients meeting DSM-IV criteria for schizophrenia and treated with Risperidone alone were evaluated regarding their clinical improvement using the Positive and Negative Syndrome Scale (PANSS) before and 2 weeks after Risperidone administration, and blood samples were also drawn at the same times. Plasma concentrations of homovanillic acid (HVA) and 3-methoxy-4-hydroxyphenylglycol were analysed by high-performance liquid chromatography with electrochemical detection. Plasma HVA levels in the responders to the Risperidone treatment (more than 50% improvement in scores of positive symptoms in PANSS) were higher than those of non-responders before Risperidone administration. Furthermore, there was a negative trend between changes in plasma HVA levels and improvement of total scores for positive symptoms in PANSS. These results suggest that higher levels of plasma HVA before Risperidone administration might be a predictor of a good response to Risperidone treatment, and the influence of Risperidone on dopaminergic activity might be associated with its efficacy in treating symptoms of schizophrenia in the acute phase.
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possible relationship between combined plasma concentrations of Risperidone plus 9 hydroxyRisperidone and extrapyramidal symptoms preliminary study
Neuropsychobiology, 2001Co-Authors: Reiji Yoshimura, Nobuhisa Ueda, Jun NakamuraAbstract:We investigated the relationships between extrapyramidal symptoms (EPS) induced by Risperidone, the dosage of Risperidone and the combined plasma concentrations of Risperidone plus its active metabolite, 9-hydroxyRisperidone, in 20 schizophrenic patients. There was a positive correlation between the scores on the Simpson and Angus Scale and both the dosage of Risperidone and the sum of the plasma levels of Risperidone and 9-hydroxyRisperidone. These results suggest that EPS induced by Risperidone increase in conjunction with both the dosage of Risperidone and the total plasma concentrations of the parent compound and its active metabolite.
Lawrence H Price - One of the best experts on this subject based on the ideXlab platform.
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a double blind placebo controlled study of Risperidone in adults with autistic disorder and other pervasive developmental disorders
Archives of General Psychiatry, 1998Co-Authors: Christopher J Mcdougle, Janice P Holmes, Derek C Carlson, Gregory H Pelton, Donald J Cohen, Lawrence H PriceAbstract:Background Neurobiological research has implicated the dopamine and serotonin systems in the pathogenesis of autism. Open-label reports suggest that the serotonin 2A –dopamine D 2 antagonist Risperidone may be safe and effective in reducing the interfering symptoms of patients with autism. Methods Thirty-one adults (age [mean+SD], 28.1±7.3 years) with autistic disorder (n=17) or pervasive developmental disorder not otherwise specified (n=14) participated in a 12-week double-blind, placebo-controlled trial of Risperidone. Patients treated with placebo subsequently received a 12-week open-label trial of Risperidone. Results For persons completing the study, 8 (57%) of 14 patients treated with Risperidone were categorized as responders (daily dose [mean ± SD], 2.9±1.4 mg) compared with none of 16 in the placebo group ( P P P P P P P Conclusion Risperidone is more effective than placebo in the short-term treatment of symptoms of autism in adults.
