A randomized, double‐blind, placebo‐ and risperidone‐controlled study on valnoctamide for acute mania
Mark WeiserLinda LeviStephen Z. LevineMeir BialerTawfeeq Shekh‐AhmadValentin MateiA. TiuganDiana CirjaliuCristinel SavaEugenia SinitaDaisy ZamoraJohn M. Davis
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Objectives Mood stabilizers administered for bipolar disorder during pregnancy, such as valproic acid, can increase the risk of congenital anomalies in offspring. Valnoctamide is a valproic acid derivative associated with a decreased risk for congenital abnormalities in animals. The present study evaluated the efficacy and safety of valnoctamide monotherapy, compared to placebo, in the treatment of patients in an acute manic episode. Methods A 3‐week, double‐blind, randomized, placebo‐ and risperidone‐controlled, parallel group trial was conducted on 173 patients in an acute manic episode. Patients were randomized to receive valnoctamide 1500 mg/d (n=71), risperidone 6 mg/d (n=32), or matching placebo (n=70). The primary outcome measure was the change in Young Mania Rating Scale (YMRS) scores. Results Valnoctamide did not differ significantly from placebo on any of the study endpoints ( YMRS , Positive and Negative Syndrome Scale , and the Clinical Global Impression Scale for Bipolar Disorder [CGI ‐BP] scales; all P >.60). Mixed models for repeated measures showed that risperidone produced significantly more improvement than placebo in the overall bipolar disorder CGI‐BP severity scale ( P =.036), and the CGI‐BP severity scale for mania ( P =.021). The Kaplan‐Meier survival curve revealed higher all‐cause discontinuation rates (mainly due to lack of efficacy) in the valnoctamide group compared to the other study groups ( P =.026). Patients with higher valnoctamide plasma levels had a numerically higher YMRS response, but this was not statistically significant. Conclusions Valnoctamide was well tolerated at 1500 mg/d but lacked efficacy in the treatment of symptoms in patients with acute mania. Possible differences between the biological mechanisms of action of valproic acid and valnoctamide are discussed.Keywords:
Clinical Global Impression
Bipolar I disorder
Discontinuation
Objective To assess critically the short-term efficacy and safety of risperidone in adolescents with schizophrenia. Method Subjects were adolescents who were attending a research day hospital as outpatients and who had received a diagnosis of schizophrenia. This was an open pilot study; after a 2-week washout period during which all psychotropic medications were gradually discontinued, subjects were treated with risperidone for 6 weeks. Dosage was regulated individually over a period of 3 weeks; starting dose was 2.0 mg/day followed by 1.0-mg increments every 2 days; maximum dose was not to exceed 10 mg/day. The main outcome measures included the Positive and Negative Syndrome Scale for Schizophrenia, the Brief Psychiatric Rating Scale, and the Clinical Global Impression. Results Ten adolescents between 11 and 18 years of age were enrolled in the study. Risperidone produced clinically and statistically significant improvement on the Positive and Negative Syndrome Scale for Schizophrenia, Brief Psychiatric Rating Scale, and Clinical Global Impression at doses ranging from 4.0 mg/day to 10.0 mg/day (mean = 6.6). There were no major adverse reactions associated with risperidone use. Conclusions Risperidone appears to have been effective and well tolerated in this sample of adolescents with schizophrenia. J. Am. Acad. Child Adolesc. Psychiatry, 1997, 36(5):694–700.
Clinical Global Impression
Dopamine antagonist
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To evaluate the short-term efficacy and safety of risperidone in a group of Asian patients with schizophrenia in an 8-week open-label, prospective study.Patients with DSM-IV schizophrenia were recruited from Woodbridge Hospital. After a washout period, they were started on a 56-day trial of risperidone. Outcome was assessed with the positive and negative syndrome scale (PANSS), the clinical global impression scale (CGI) and the extrapyramidal symptom rating scale (ESRS).The mean daily risperidone dose at end point was 5.6 mg (range, 3 to 8 md/day). Mean PANSS scores were reduced significantly from 78 +/- 15.1 at baseline to 56.6 +/- 10.9 at end point. Seventeen patients (85%) who were treatment responders, showed at least a 20% reduction in total PANSS scores at end point while nine patients (45%) had a greater than 50% reduction in the total PANSS scores. According to the CGI scale, 85% improved at end point. The severity of extrapyramidal symptoms (mean ESRS scores) were significantly lower at end point than at baseline.Risperidone was effective in the treatment of positive and negative symptoms of schizophrenia.
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Extrapyramidal disorder
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Extrapyramidal symptoms
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This prospective study was carried out on 53 in-patients suffering from chronic schizophrenia. Before the Risperidone treatment they were on the convenient antipsychotic therapy - haloperidol average doses 9.6 mg pro die, or Fluphenazine average 4.2 mg pro die. The aim of the study was to follow up therapeutically effects of Risperidone, using PANSS scale for schizophrenia, during two months, by two- weeks visits. Results On average dose of Risperidone 5.1 mg pro die there was found 18.2% reduction on the Positive syndrome scale after two months. Negative syndrome scale showed improvement of 20.5%; General psychopathology scale was reduced for 15.7%. Finally, total PANSS score was reduced 17.2%. Results were also discussed according to sex, age, illness duration and schizophrenia type. Conclusion Therapeutically efficacy of Risperidone has been shown on the positive, as so as the negative schizophrenia symptoms. Better results were in disorganized form of schizophrenia then the paranoid form.
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OBJECTIVES: The objectives of the study were to investigate the difference in negative scale score in schizophrenic male patients that received vitamin E-fortified risperidone and those receiving risperidone treatments alone. METHODS: This study was a pre- and post-test experimental design which compared two groups; a group of men with schizophrenia who were given risperidone treatment with added Vitamin E and another group of men with schizophrenia who were given only risperidone treatment. The study was conducted at the outpatient clinic of Prof.dr. M. Ildrem Mental Hospital Medan, North Sumatra within August to November 2019. The study has been approved by the Research Ethics Committee of the Faculty of Medicine, North Sumatera University. The instrument used to assess negative scale on the subjects is PANSS. RESULTS: We found that statistical analysis using corrected Mann–Whitney U-test obtained p < 0.001 (p < 0.05). CONCLUSIONS: There was a strongly significant difference in negative scale Positive and Negative Syndrome Scale (PANSS) scores on 4th and 8th weeks in the group which received risperidone treatment with additional Vitamin E compared to the other group that received risperidone alone.
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Background: Schizophrenia is a chronic debilitating disease with significant morbidity and mortality that often requires either typical or atypical antipsychotic pharmacotherapy. Atypical antipsychotic drugs are preferred over typical because of lower risk of extra pyramidal side effects. As there is paucity of data in Indian population, the present study was taken up to evaluate the efficacy of haloperidol and risperidone in the treatment of schizophrenia.Methods: It was a comparative study conducted on 60 patients of Schizophrenia for one year in a tertiary care hospital. The study subjects were randomly assigned into 2 groups of 30 patients each, where group 1 were treated with atypical antipsychotic drug risperidone and group 2 with typical antipsychotic drug Haloperidol and both groups received the treatment for one year. Efficacy was measured using positive and negative syndrome scale (PANSS), clinical global impression - severity of illness (CGI-S), clinical global impression - improvement (CGI-I) scales.Results: Both haloperidol and risperidone were associated with comparable baseline to endpoint reduction in symptom severity. However, risperidone treated subjects had significantly greater decrease in symptom severity as measured by PANSS score and total score, CGI-S scale. However, there is no significant difference between two groups in terms of CGI-S score.Conclusions: The reduction in positive, negative and general scores in risperidone treated patients were significant with that of haloperidol treated patients.
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Typical antipsychotic
Antipsychotic Agent
Pharmacotherapy
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Risperidone long-acting injection (RLAI) was shown to be an alternative option in adult patients, but there is not available data in child and adolescents about this medication. The aim of this study is to evaluate the safety and efficiency profile of RLAI in a group of adolescents.Eleven cases with conduct disorder and severe aggressive behaviors were initiated treatment with risperidone oral form. All cases were then shifted to RLAI 25 mg injection in each 15 days due to poor compliance to oral risperidone treatment. Efficiency of treatment included indicators of clinical severity and improvement, which were evaluated by Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I). Safety evaluation was performed by using Extrapyramidal Symptoms Rating Scale, and by monitoring body weight. Follow-up visits were done at the treatment initiation, and 8th, 16th, and 24th weeks of first injection.Study included 9 girls, and 2 boys, with a mean age of 14.9±1.0 years. The CGI-S scores decreased from 6.6±0.5 at the beginning to 2.2±1.1 at the last visit (p＜0.001), which is a very significant decrease through better clinical level. The CGI-I scores were also improved significantly from 2.4±0.5 to 1.9±0.5 at 24th week (p=0.001). Safety parameters were also showed favorable results, which there was no significant weight gain (p=0.076), and well-tolerated extrapyramidal adverse effects.Our results showed that RLAI is an efficient and safe medication option in the treatment of psychiatric disorders and severe behavioral problems in adolescents with low-compliance to oral treatment in our cases.
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Extrapyramidal symptoms
Safety profile
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OBJECTIVE To discuss the economic effects or different therapeutic schemes in the treatment of schizophrenia.METHODS A total of 64 patients with schizophrenia were randomly assigned to MECT group and risperidone group,and received risperidone or MECT treatment for 12 weeks respectively.The efficacy and adverse events were assessed with the positive and negative syndrome scale(PANSS),and treatment emergent symptom scale(TESS) at week 0 and 1,2,4,8,12.the effect and costs of two therapies were compared with the pharmacoeconomic cost-effectiveness analysis.RESULTS The PANSS scores in mect group deecreased significantly after reatment 2 weeks(P0.05).the PANSS scores in risperidone group decreased significantly after reatment 4 weeks(P0.05).the PANSS total score and negative syndrome score in both groups were not significantat at each time point from 4th weekend after treatment(P0.05).By the end of week 12,total clinical effective rates were 75% in MECT group and 69% in risperido group,without any statiscally singnificant difference between the two groups.no severe adverse events were reported in both group.the costs of two groups were 9454.35yuan and 9772.78yuan.CONCLUSION MECT has similar costs to risperidone in the antipsychotic treatment.MECT taking effect more quickly and less side effects.
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Endoxifen is a protein kinase C inhibitor. The objective of the present phase III study was to demonstrate the safety and efficacy of endoxifen in treating bipolar I disorder (BPD I) patients.A multicenter, double-blind, active-controlled study was conducted using a daily dose of 8 mg endoxifen compared to 1000 mg divalproex, the current standard treatment, in patients with BPD I acute manic episodes with/without mixed features. The primary endpoint of our study was the mean change in total Young Mania Rating Scale (YMRS) score at day 21.Endoxifen (n = 116) significantly (p < 0.0001) reduced total YMRS score (from 33.1 to 17.8. A significant (p < 0.001) improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) score was observed for endoxifen (4.8 to 2.5). Early time to remission of the disease was observed with endoxifen compared to divalproex. None of the patients required rescue medication and there was no drug-associated withdrawals. Changes in Clinical Global Impressions-Bipolar Disorder and Clinical Global Impression-Severity of Illness scores showed that treatment with endoxifen was well-tolerated.Endoxifen at a low daily dose of 8 mg was as efficacious and safe in patients with BPD I acute manic episodes with/without mixed features.
Clinical Global Impression
Bipolar I disorder
Divalproex
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Aims: This unique study of treatment of the mixed state of bipolar I disorder using simultaneous depression and mania response criteria compared divalproex monotherapy versus olanzapine augmentation in a 6-week, randomized, double-blind trial. Methods: Patients (age 18-60 years) with 14-28 days of divalproex monotherapy (blood levels of 75-125 μg/mL) were randomized to augmentation with olanzapine 5-20 mg/day or placebo. Data collected included: Hamilton Depression Rating Scale (HDRS), Young Mania Rating Scale (YMRS), Clinical Global Impression for Bipolar Illness (CGI-BP), hospitalizations, concomitant medications, and adverse events (AEs). Primary co-objectives were comparisons of baseline to endpoint changes in HDRS and YMRS. Secondary objectives included comparisons of times to onset (25% reduction) and response (50% reduction) in both HDRS and YMRS, change in CGI-BP, hospitalizations, and safety. Results: Patients were 59% female, 51% Caucasian, 33% African American, and 14% Hispanic with mean standard deviation (SD) HDRS and YMRS scores of 22.2 (4.5) and 20.9 (4.4). Mean standard error (SE) score changes for the olanzapine (n=100) or placebo (n=101) arms, respectively, were: HDRS, -9.37 (.55) and -7.69 (.54), p=.022; YMRS, -10.15 (.44) and -7.68 (.44), p< .001; and CGI-BP, -1.34 (.11) and -1.06 (.11), p=.056. Times-to-onset (median 7 vs 14 days) and response (median 25 vs 49 days) were significantly shorter for olanzapine augmentation. One olanzapine patient required hospitalization (p=1.0). Treatment-emergent AEs were consistent with previously-published rates. Conclusion: Six-week olanzapine treatment augmentation was associated with greater and earlier reduction of manic and depressive symptoms in mixed episode patients on divalproex treatment.
Divalproex
Clinical Global Impression
Bipolar I disorder
Bipolar II disorder
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