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John Panagides - One of the best experts on this subject based on the ideXlab platform.
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Asenapine for long term treatment of bipolar disorder a double blind 40 week extension study product news
African Journal of Psychiatry, 2012Co-Authors: Roger S. Mcintyre, Jun Zhao, M. Cohen, Larry Alphs, John Panagides, Thomas A. MacekAbstract:Asenapine is approved in the United States for acute treatment of manic or mixed episodes of bipolar I disorder with or without psychotic features. We report the results of long-term treatment with Asenapine in patients with bipolar I disorder.
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Long-term efficacy and safety of Asenapine or olanzapine in patients with schizophrenia or schizoaffective disorder: an extension study.
Pharmacopsychiatry, 2012Co-Authors: J. Schoemaker, John Panagides, Dieter Naber, P Vrijland, Stet L, Robin EmsleyAbstract:Safety and efficacy results, collected in schizophrenia and schizoaffective disorder patients treated for up to nearly 3 years, are presented for Asenapine and olanzapine. Patients completing a 52-week randomized double-blind core study on flexible-dose Asenapine (5 or 10 mg BID) or olanzapine (10 or 20 mg QD) could continue treatment until study blind was broken. 290 patients on Asenapine and 150 on olanzapine continued treatment for variable lengths of time [mean±SD (range) 311.0±146.1 (10 − 653) d and 327.4±139.6 (15 − 631) d, respectively]. Adverse event (AE) incidence was lower during the extension (Asenapine, 62%; olanzapine, 55%) than during the core study (78%, 80%). In both groups, body weight increase and incidence of extrapyramidal AEs were negligible during the extension. Mean PANSS total score changes during first year of treatment were − 37.0 for Asenapine and − 35.3 for olanzapine, with further changes of 1.6 for Asenapine and − 0.8 for olanzapine at the extension study endpoint. Clinical stability on Asenapine as well as olanzapine was maintained, with few recurrent or newly emerging AEs beyond 1 year of treatment. NCT number: NCT00212771
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Asenapine as adjunctive treatment for acute mania associated with bipolar disorder results of a 12 week core study and 40 week extension
Journal of Clinical Psychopharmacology, 2012Co-Authors: Armin Szegedi, Mary Mackle, Jun Zhao, Joseph R Calabrese, L Stet, John PanagidesAbstract:AbstractIn a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive Asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily Asenapine 5 o
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Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia.
Journal of clinical psychopharmacology, 2012Co-Authors: Robert W. Buchanan, Jun Zhao, Larry Alphs, John Panagides, Phillip Phiri, Wil Den Hollander, Alex Kouassi, Nina Schooler, Armin SzegediAbstract:Two randomized, double-blind, 26-week core studies (Eastern [EH] and Western Hemisphere [WH]) tested the hypothesis that Asenapine is superior to olanzapine for persistent negative symptoms of schizophrenia; 26-week extension studies assessed the comparative long-term efficacy and safety of these agents. In the core studies, 949 people were randomized to Asenapine (n = 241 and 244) or olanzapine (n = 240 and 224); 26-week completion rates with Asenapine were 64.7% and 49.6% (olanzapine, 80.4% and 63.8%) in the EH and WH, respectively. In the EH and WH extensions, respectively (Asenapine, n = 134 and 86; olanzapine, n = 172 and 110), 52-week completion rates were 84.3% and 66.3% with Asenapine (olanzapine, 89.0% and 80.9%). Asenapine was not superior to olanzapine in change in the 16-item Negative Symptom Assessment Scale total score in either core study, but Asenapine was superior to olanzapine at week 52 in the WH extension study. Olanzapine was associated with modest, but significantly greater, changes in PANSS positive subscale score at various assessment times in both core studies and the WH extension study. Incidence of treatment-emergent adverse events was comparable between treatments across studies. Weight gain was consistently lower with Asenapine. Extrapyramidal symptom-related adverse event incidence was higher with Asenapine (EH: 8.3%; 95% confidence interval [CI], 5.1%-12.5%; WH: 16.4%; 95% CI, 11.9%-21.6%) than olanzapine (EH: 3.3%; 95% CI, 1.4%-6.4%; WH: 12.1%; 95% CI, 8.1%-17.0%), but Extrapyramidal Symptom Rating Scale-Abbreviated total score changes did not significantly differ between treatments. In conclusion, Asenapine superiority over olanzapine was not observed in the core studies. Both treatments improved persistent negative symptoms, but discontinuation rates were higher with Asenapine.
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a randomized placebo controlled trial of Asenapine for the prevention of relapse of schizophrenia after long term treatment
The Journal of Clinical Psychiatry, 2011Co-Authors: John M Kane, Mary Mackle, Armin Szegedi, Jun Zhao, Linda Snowadami, John PanagidesAbstract:OBJECTIVE Long-term efficacy of Asenapine in preventing schizophrenia relapse was assessed in a 26-week double-blind, placebo-controlled trial that followed 26 weeks of open-label treatment. METHOD Stable schizophrenia patients (DSM-IV-TR criteria) who were cross-titrated from previous medication to sublingual Asenapine and remained stable during 26 weeks of open-label treatment were eligible for 26 weeks of double-blind treatment, with randomization to continued Asenapine or switch to placebo. Time to relapse/impending relapse (primary endpoint, as usually determined by specific scores on the Positive and Negative Syndrome Scale and the Clinical Global Impressions-Severity of Illness Scale) and discontinuation for any reason (key secondary endpoint) were assessed by survival analyses for Asenapine versus placebo. The study was conducted from May 2005 through June 2008. RESULTS Of 700 enrolled patients treated with open-label Asenapine, 386 entered (Asenapine, n = 194; placebo, n = 192) and 207 completed (n = 135; n = 72) the double-blind phase. Times to relapse/impending relapse and discontinuation for any reason were significantly longer with Asenapine than with placebo (both P < .0001). Incidence of relapse/impending relapse was lower with Asenapine than placebo (12.1% vs 47.4%, P < .0001). The modal dosage of Asenapine was 10 mg twice daily in both phases. During the double-blind phase, the incidence of adverse events (AEs) considered serious with Asenapine and placebo was 3.1% and 9.9%, respectively; incidence of extrapyramidal symptom-related AEs was 3.1% and 4.7%, respectively. The most frequently reported AEs with Asenapine versus placebo were anxiety (8.2%; 10.9%), increased weight (6.7%; 3.6%), and insomnia (6.2%; 13.5%). The incidence of clinically significant weight gain (≥ 7% increase from double-blind baseline) was 3.7% with Asenapine and 0.5% with placebo. CONCLUSIONS Long-term treatment with Asenapine was more effective than placebo in preventing relapse of schizophrenia and appeared to be safe and well tolerated. TRIAL REGISTRATION clinicaltrials.gov Identifier NCT00150176.
Jun Zhao - One of the best experts on this subject based on the ideXlab platform.
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effects of Asenapine in bipolar i patients meeting proxy criteria for moderate to severe mixed major depressive episodes a post hoc analysis
The Journal of Clinical Psychiatry, 2015Co-Authors: Michael Berk, Jun Zhao, John Tiller, Lakshmi N Yatham, Gin S Malhi, Emmanuelle WeillerAbstract:OBJECTIVE: Depression is the predominant psychosocial and suicide burden in bipolar disorder, yet there is a paucity of evidence-based treatments for bipolar depression. METHODS: This post hoc subgroup analysis of data pooled from two 3-week, randomized, placebo- and olanzapine-controlled trials (December 2004-April 2006, N = 489 and November 2004-April 2006, N = 488) examined a subgroup of patients meeting criteria for moderate-to-severe mixed major depressive episodes, defined using DSM-IV-TR criteria for mixed episodes (mania and major depression simultaneously) with a baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 20. RESULTS: Decreases in MADRS scores (least squares mean [SE]), the a priori primary outcome, were significantly greater in the Asenapine group than in the placebo group from baseline to day 7 (-11.02 [1.82] vs -4.78 [1.89]; P = .0195), day 21 (-14.03 [2.01] vs -7.43 [2.09]; P = .0264), and endpoint (-10.71 [1.76] vs -5.19 [1.98]; P = .039). Decreases in MADRS scores with Asenapine were significantly greater than with olanzapine from baseline to day 7 (-6.26 [1.47]; P = .0436). Decreases in Young Mania Rating Scale mean total score were greater with Asenapine than with placebo or olanzapine at all time points assessed. A significantly greater reduction from baseline to day 21 in the Short Form-36 mental component summary score was observed with Asenapine, but not olanzapine, compared with placebo (16.57 vs 5.97; P = .0093). Asenapine was generally well tolerated. CONCLUSIONS: These data provide support for the potential efficacy of Asenapine in mixed major depressive episodes; however, these data cannot be linearly extrapolated to nonmixed major depression.
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Weight change and metabolic effects of Asenapine in patients with schizophrenia and bipolar disorder.
The Journal of clinical psychiatry, 2013Co-Authors: David E. Kemp, Pilar Cazorla, Mary Mackle, Jun Zhao, Ronald P. Landbloom, Linda Snow-adami, Armin SzegediAbstract:OBJECTIVE To describe weight changes and metabolic effects of Asenapine compared with placebo and olanzapine in adults. METHOD Post hoc analyses were performed using data from 17 Asenapine trials (13 schizophrenia and 4 bipolar mania trials) with placebo (5-10 mg twice daily; n = 1,748; 1-6 weeks) and/or olanzapine (5-20 mg, once daily; n = 3,430; 3-100 weeks). Data were pooled based on treatment into placebo-controlled and olanzapine-controlled trials. For trials with placebo and olanzapine treatment groups, the Asenapine population was included in both pools. Changes from baseline for weight, body mass index, and fasting lipid and glucose levels were determined. The Medical Dictionary for Regulatory Activities was used to define metabolic adverse events. RESULTS Mean (standard error [SE]) weight change was greater with Asenapine than with placebo (1.2 [0.2] vs 0.14 [0.2] kg; P < .0001) and similar in schizophrenia and bipolar disorder. Mean changes differed for Asenapine versus placebo in triglycerides (1.8 [6.3] vs -12.2 [5.9] mg/dL; P < .01) and fasting glucose (1.9 [1.7] vs -1.6 [1.5] mg/dL; P < .05). In the olanzapine-controlled trials, weight change was significantly lower with Asenapine than with olanzapine (0.9 [0.1] vs 3.1 [0.2] kg; P < .0001). Changes associated with Asenapine were lower than those with olanzapine in fasting glucose (2.0 vs 3.3 mg/dL), total cholesterol (-0.4 [1.1] vs 6.2 [1.2] mg/dL; P < .0001), low-density lipoprotein cholesterol (-0.3 [1.1] vs 3.1 [1.2] mg/dL; P < .01), and triglycerides (-0.9 [5.4] vs 24.3 [5.8] mg/dL; P < .0001). CONCLUSIONS Asenapine was associated with greater weight gain and glucose changes than placebo and not associated with a meaningful change in triglycerides or cholesterol levels. Asenapine was not significantly different from olanzapine in change in glucose levels and lower than olanzapine with respect to triglycerides, weight gain, and increased cholesterol.
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comparison of somnolence associated with Asenapine olanzapine risperidone and haloperidol relative to placebo in patients with schizophrenia or bipolar disorder
Neuropsychiatric Disease and Treatment, 2013Co-Authors: Mary Mackle, Pilar Cazorla, Jun Zhao, Armin SzegediAbstract:Background: Patients with schizophrenia or bipolar disorder (BPD) may be differentially sensitive to antipsychotics. This study assessed the median time to onset, duration, and rate of somnolence associated with Asenapine and other antipsychotics in both indications. Methods: Ten clinical trials (n = 4786) were analyzed as five cohorts pooled according to indication and study design. Results: In the short-term schizophrenia cohort, the incidence of somnolence was 13.1%, 19.1%, 8.5% 5.2%, and 6.9% with Asenapine, olanzapine, risperidone, haloperidol, and placebo, respectively. Median time to onset of somnolence was 2 days for Asenapine and olanzapine, and 6, 3, and 7 days for risperidone, haloperidol, and placebo, respectively. Median duration was 15 days for Asenapine and olanzapine, and 3, 22.5, and 4.5 days for risperidone, haloperidol, and placebo, respectively. In the long-term schizophrenia cohort, the incidence, time to onset, and duration of somnolence with Asenapine and olanzapine were 18.4% versus 19.6%, 9.0 days versus 12 days, and 22 days versus 21 days, respectively. In schizophrenia with persistent negative symptoms, the incidence, median time to onset, and duration of somnolence with Asenapine and olanzapine were 18.5% versus 21.1%, 9.0 days versus 7.5 days, and 25.0 days versus 41.5 days, respectively. In the monotherapy for BPD cohort, the incidence of somnolence with Asenapine, olanzapine, and placebo was 23.8%, 26.4%, and 6.4%, respectively. Median time to onset and duration of somnolence with Asenapine, olanzapine, and placebo were 1, 2, and 2 days, respectively, and 7, 8.5, and 5 days. In the adjunctive therapy for BPD cohort, the incidence, median time to onset, and duration of somnolence with Asenapine and placebo were 24.0% versus 10.2%, 1.5 days versus 2 days, and 12.5 days versus 7 days, respectively. Conclusion: In the short-term schizophrenia cohort, time to onset and duration of somnolence with Asenapine was similar to that with olanzapine and haloperidol. Only Asenapine and olanzapine had significantly higher rates of somnolence relative to placebo. The time to onset, duration, and incidence of somnolence with Asenapine and olanzapine was similar in patients with long-term schizophrenia and those with BPD. Patients with BPD were more sensitive than those with schizophrenia to Asenapine and olanzapine.
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Asenapine for long term treatment of bipolar disorder a double blind 40 week extension study product news
African Journal of Psychiatry, 2012Co-Authors: Roger S. Mcintyre, Jun Zhao, M. Cohen, Larry Alphs, John Panagides, Thomas A. MacekAbstract:Asenapine is approved in the United States for acute treatment of manic or mixed episodes of bipolar I disorder with or without psychotic features. We report the results of long-term treatment with Asenapine in patients with bipolar I disorder.
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Asenapine as adjunctive treatment for acute mania associated with bipolar disorder results of a 12 week core study and 40 week extension
Journal of Clinical Psychopharmacology, 2012Co-Authors: Armin Szegedi, Mary Mackle, Jun Zhao, Joseph R Calabrese, L Stet, John PanagidesAbstract:AbstractIn a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive Asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily Asenapine 5 o
Armin Szegedi - One of the best experts on this subject based on the ideXlab platform.
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Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar I Disorder.
Journal of the American Academy of Child and Adolescent Psychiatry, 2015Co-Authors: Robert L. Findling, Mary Mackle, Armin Szegedi, Ronald L Landbloom, Janelle Koppenhaver, Sabine Braat, Qi Zhu, Kiki D. Chang, Maju MathewsAbstract:Objective To evaluate Asenapine versus placebo in 403 patients aged 10 to 17 years with bipolar I disorder currently in manic or mixed episodes. Method In this double-blind, placebo-controlled, international trial, patients were randomized 1:1:1:1 to placebo, Asenapine 2.5, 5, or 10 mg b.i.d. (twice daily). Primary efficacy measure was change from baseline in Young-Mania Rating Scale (YMRS) total score at day 21. Analyses of patients with/without attention-deficit/hyperactivity disorder (ADHD) and with/without stimulant use were performed. Results The mean difference in Asenapine versus placebo in YMRS was –3.2 ( p = .0008), –5.3 ( p p p Conclusion All Asenapine doses versus placebo were superior based on change in YMRS at day 21. Asenapine was generally well tolerated in patients aged 10 to 17 years with bipolar I disorder in manic or mixed states. Increases in weight and fasting insulin were associated with Asenapine. Clinical trial registration information— Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder; http://clinicaltrials.gov ; NCT01244815 .
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Weight change and metabolic effects of Asenapine in patients with schizophrenia and bipolar disorder.
The Journal of clinical psychiatry, 2013Co-Authors: David E. Kemp, Pilar Cazorla, Mary Mackle, Jun Zhao, Ronald P. Landbloom, Linda Snow-adami, Armin SzegediAbstract:OBJECTIVE To describe weight changes and metabolic effects of Asenapine compared with placebo and olanzapine in adults. METHOD Post hoc analyses were performed using data from 17 Asenapine trials (13 schizophrenia and 4 bipolar mania trials) with placebo (5-10 mg twice daily; n = 1,748; 1-6 weeks) and/or olanzapine (5-20 mg, once daily; n = 3,430; 3-100 weeks). Data were pooled based on treatment into placebo-controlled and olanzapine-controlled trials. For trials with placebo and olanzapine treatment groups, the Asenapine population was included in both pools. Changes from baseline for weight, body mass index, and fasting lipid and glucose levels were determined. The Medical Dictionary for Regulatory Activities was used to define metabolic adverse events. RESULTS Mean (standard error [SE]) weight change was greater with Asenapine than with placebo (1.2 [0.2] vs 0.14 [0.2] kg; P < .0001) and similar in schizophrenia and bipolar disorder. Mean changes differed for Asenapine versus placebo in triglycerides (1.8 [6.3] vs -12.2 [5.9] mg/dL; P < .01) and fasting glucose (1.9 [1.7] vs -1.6 [1.5] mg/dL; P < .05). In the olanzapine-controlled trials, weight change was significantly lower with Asenapine than with olanzapine (0.9 [0.1] vs 3.1 [0.2] kg; P < .0001). Changes associated with Asenapine were lower than those with olanzapine in fasting glucose (2.0 vs 3.3 mg/dL), total cholesterol (-0.4 [1.1] vs 6.2 [1.2] mg/dL; P < .0001), low-density lipoprotein cholesterol (-0.3 [1.1] vs 3.1 [1.2] mg/dL; P < .01), and triglycerides (-0.9 [5.4] vs 24.3 [5.8] mg/dL; P < .0001). CONCLUSIONS Asenapine was associated with greater weight gain and glucose changes than placebo and not associated with a meaningful change in triglycerides or cholesterol levels. Asenapine was not significantly different from olanzapine in change in glucose levels and lower than olanzapine with respect to triglycerides, weight gain, and increased cholesterol.
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comparison of somnolence associated with Asenapine olanzapine risperidone and haloperidol relative to placebo in patients with schizophrenia or bipolar disorder
Neuropsychiatric Disease and Treatment, 2013Co-Authors: Mary Mackle, Pilar Cazorla, Jun Zhao, Armin SzegediAbstract:Background: Patients with schizophrenia or bipolar disorder (BPD) may be differentially sensitive to antipsychotics. This study assessed the median time to onset, duration, and rate of somnolence associated with Asenapine and other antipsychotics in both indications. Methods: Ten clinical trials (n = 4786) were analyzed as five cohorts pooled according to indication and study design. Results: In the short-term schizophrenia cohort, the incidence of somnolence was 13.1%, 19.1%, 8.5% 5.2%, and 6.9% with Asenapine, olanzapine, risperidone, haloperidol, and placebo, respectively. Median time to onset of somnolence was 2 days for Asenapine and olanzapine, and 6, 3, and 7 days for risperidone, haloperidol, and placebo, respectively. Median duration was 15 days for Asenapine and olanzapine, and 3, 22.5, and 4.5 days for risperidone, haloperidol, and placebo, respectively. In the long-term schizophrenia cohort, the incidence, time to onset, and duration of somnolence with Asenapine and olanzapine were 18.4% versus 19.6%, 9.0 days versus 12 days, and 22 days versus 21 days, respectively. In schizophrenia with persistent negative symptoms, the incidence, median time to onset, and duration of somnolence with Asenapine and olanzapine were 18.5% versus 21.1%, 9.0 days versus 7.5 days, and 25.0 days versus 41.5 days, respectively. In the monotherapy for BPD cohort, the incidence of somnolence with Asenapine, olanzapine, and placebo was 23.8%, 26.4%, and 6.4%, respectively. Median time to onset and duration of somnolence with Asenapine, olanzapine, and placebo were 1, 2, and 2 days, respectively, and 7, 8.5, and 5 days. In the adjunctive therapy for BPD cohort, the incidence, median time to onset, and duration of somnolence with Asenapine and placebo were 24.0% versus 10.2%, 1.5 days versus 2 days, and 12.5 days versus 7 days, respectively. Conclusion: In the short-term schizophrenia cohort, time to onset and duration of somnolence with Asenapine was similar to that with olanzapine and haloperidol. Only Asenapine and olanzapine had significantly higher rates of somnolence relative to placebo. The time to onset, duration, and incidence of somnolence with Asenapine and olanzapine was similar in patients with long-term schizophrenia and those with BPD. Patients with BPD were more sensitive than those with schizophrenia to Asenapine and olanzapine.
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Meta-analyses of the efficacy of Asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics.
The Journal of clinical psychiatry, 2012Co-Authors: Armin Szegedi, Pilar Cazorla, Mary Mackle, Pierre Verweij, Wilbert Van Duijnhoven, Hein FennemaAbstract:CONTEXT Asenapine is an approved treatment for schizophrenia in the United States. OBJECTIVE Meta-analyses were conducted to evaluate the efficacy of Asenapine in acute schizophrenia compared with placebo and other antipsychotics. DATA SOURCES Four Asenapine trials from the Asenapine development program were pooled for the meta-analysis. To compare Asenapine versus placebo treatment effect with other antipsychotics, we added integrated Asenapine data to a previously published meta-analysis. For comparative efficacy of Asenapine versus other second-generation antipsychotics (SGAs), data from a second published meta-analysis were combined with the 4 Asenapine trials. DATA ANALYSES To evaluate efficacy, mean change in Positive and Negative Syndrome Scale (PANSS) total score was examined in Asenapine and other antipsychotics. To assess clinical relevance, PANSS response rates and associated odds ratios (ORs) for treatment response were assessed. To assess the relative efficacy of SGAs, a network meta-analysis with PANSS total score change was conducted by using data from the 2 published meta-analyses together with Asenapine data. RESULTS Asenapine was superior to placebo with regard to mean change in PANSS total score (last observation carried forward [LOCF]: -3.6, P = .002; mixed model for repeated measures [MMRM]: -4.1, P = .001), an effect comparable to active controls from the same trials (LOCF: -4.0, P = .002; MMRM: -4.8, P = .001). PANSS responder rates were significantly better with Asenapine versus placebo (OR, 1.9; P < .001) and comparable to active controls (OR, 1.7; P = .002). Effect sizes for Asenapine were somewhat lower than those reported in the literature for other SGAs. Network meta-analysis also demonstrated that the efficacy of Asenapine was comparable to that of other SGAs; estimated differences between Asenapine and other SGAs ranged from 3.9 points (95% CI, 0.3 to 7.4) greater than ziprasidone to 2.9 points (95% CI, -0.1 to 5.9) less than olanzapine. CONCLUSIONS These meta-analyses indicate that the efficacy of Asenapine for acute schizophrenia is superior to placebo and comparable to several other SGAs.
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Asenapine as adjunctive treatment for acute mania associated with bipolar disorder results of a 12 week core study and 40 week extension
Journal of Clinical Psychopharmacology, 2012Co-Authors: Armin Szegedi, Mary Mackle, Jun Zhao, Joseph R Calabrese, L Stet, John PanagidesAbstract:AbstractIn a 12-week randomized, placebo-controlled study evaluating the efficacy and safety of adjunctive Asenapine, bipolar I disorder patients experiencing manic or mixed episodes despite pretreatment with lithium or valproate monotherapy were treated with flexible-dose, twice-daily Asenapine 5 o
Roger S. Mcintyre - One of the best experts on this subject based on the ideXlab platform.
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Asenapine for the treatment of adults with an acute exacerbation of schizophrenia results from a randomized double blind fixed dose placebo controlled trial with olanzapine as an active control
Cns Spectrums, 2017Co-Authors: Ronald P. Landbloom, Mary Mackle, Roger S. Mcintyre, Maju Mathews, Linda J Kelly, Linda Snowadami, Carla HundtAbstract:Objective Evaluate the efficacy and safety of Asenapine 2.5 mg twice daily (bid; n=97) or 5 mg bid (n=113) versus placebo (n=101) in adults with acute exacerbation of schizophrenia. Methods Adults with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia diagnosis were randomized to Asenapine 2.5 mg bid, 5 mg bid, placebo, or olanzapine 15 mg once daily. The primary objective was to test superiority of Asenapine versus placebo as measured by the change from baseline to day 42 in the Positive and Negative Syndrome Scale (PANSS) total score. The key safety objective was to evaluate weight change in Asenapine versus olanzapine at day 42. Results The primary efficacy endpoint was met; the difference in least squares mean change from baseline to day 42 in PANSS total score between Asenapine 5 mg bid and placebo was −5.5 points (unadjusted 95% CI: −10.1, −1.0; multiplicity adjusted P=0.0356). Neither Asenapine 2.5 mg bid nor olanzapine 15mg were superior to placebo. Both Asenapine groups demonstrated significantly less weight gain than olanzapine at day 42. Significantly higher incidences of oral hypoesthesia and dysgeusia (combined) for Asenapine 2.5 mg bid (5.2% vs 0.0%; P=0.0217) and 5 mg bid (7.1% vs 0.0%; P=0.0033) were observed versus placebo. There were no significant differences between Asenapine and placebo for insomnia, extrapyramidal symptoms, akathisia, dizziness, or combination of somnolence/sedation/hypersomnia. Conclusion This study supports previous efficacy and safety findings of Asenapine; Asenapine 5 mg bid is the lowest effective dose in adults with schizophrenia. Asenapine was associated with significantly less weight gain than olanzapine at day 42.
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Asenapine efficacy and safety of 5 and 10 mg bid in a 3 week randomized double blind placebo controlled trial in adults with a manic or mixed episode associated with bipolar i disorder
Journal of Affective Disorders, 2016Co-Authors: Ronald L Landbloom, Mary Mackle, Roger S. Mcintyre, Maju Mathews, Linda J Kelly, Linda Snowadami, Carla HundtAbstract:Abstract Background Asenapine is an atypical antipsychotic for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The recommended Asenapine starting dose is 10 mg bid with the option to reduce the dose to 5 mg bid if needed due to adverse effects/tolerability. Methods Phase IIIb, international, double-blind, fixed-dose, parallel-group, 3-week placebo-controlled trial of Asenapine 5 and 10 mg bid in adults with an acute bipolar I disorder manic or mixed episode. Primary outcome was difference in Asenapine versus placebo in mean change from baseline to day 21 in the Young-Mania Rating Scale (YMRS) total score. Others included difference in Asenapine versus placebo in the Clinical Global Impression Scale for Bipolar Severity (CGI-BP-S) and rate of YMRS responders. Results Both Asenapine doses were statistically superior to placebo in mean change from baseline to day 21 in YMRS total score (−10.9, −14.4, and −14.9 for placebo, Asenapine 5 mg bid, 10 mg bid, respectively). Both Asenapine doses had statistically superior improvement in mean change in CGI-BP-S score at day 21. Neither Asenapine dose had significantly more YMRS responders at day 21 than placebo. Limitations Results may not be generalizable to the entire population with bipolar I disorder owing to strict inclusion criteria. Conclusions This study evaluated, by a fixed-dose design, the efficacy and safety of Asenapine versus placebo in patients with bipolar I disorder. Both Asenapine 5 and 10 mg bid were efficacious in treating mania associated with bipolar I disorder and were generally well tolerated.
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Asenapine for long term treatment of bipolar disorder a double blind 40 week extension study product news
African Journal of Psychiatry, 2012Co-Authors: Roger S. Mcintyre, Jun Zhao, M. Cohen, Larry Alphs, John Panagides, Thomas A. MacekAbstract:Asenapine is approved in the United States for acute treatment of manic or mixed episodes of bipolar I disorder with or without psychotic features. We report the results of long-term treatment with Asenapine in patients with bipolar I disorder.
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Asenapine: A Synthesis of Efficacy Data in Bipolar Mania and Schizophrenia
Clinical schizophrenia & related psychoses, 2012Co-Authors: Roger S. Mcintyre, Rosary WongAbstract:Introduction: This article briefly reviews the efficacy, as well as safety and tolerability, data pertaining to Asenapine in bipolar mania and schizophrenia. Postulated mechanism of action is also reviewed. Methods: A PubMed search was conducted using the search term Asenapine. All displayed articles were reviewed; we selected for review studies that were part of the regulatory registration package to the FDA as part of the bipolar disorder and schizophrenia indication. We also included a review of articles reporting on Asenapine’s preclinical profile. Results: Asenapine is a recently introduced atypical antipsychotic approved by the FDA for bipolar mania and mixed states with or without psychotic features, as well as for the treatment and prevention of psychotic relapses in schizophrenia. Preliminary evidence suggests that Asenapine mitigates depressive symptoms in bipolar mania and offers superior efficacy to olanzapine or risperidone in the negative symptoms of schizophrenia. The pharmacodynamic profile of Asenapine provides a ratio nale for hypothesizing efficacy in the treatment of cognitive deficits in mood and psychotic disorders. Asenapine is associated with sedation and/or somnolence; it has a lower propensity to weight gain and metabolic disruption than olanzapine. Extrapyramidal side effects (EPS) are associated with Asenapine and may be dose-dependent. Asenap ine is not associated with sustained hyperprolactinemia or cardiovascular toxicity. Dysgeusia and oral hypoesthesia/ paresthesia is associated with Asenapine, but is rarely a cause for treatment discontinuation. Conclusions: Asenapine is the only atypical antipsychotic available exclusively as a sublingual, fast-dissolved formulation. Electrophysiological, behavioral, pharmacological, and radioligand studies are predictive of antidepressant, mood-stabilizing, as well as antipsychotic, effects.
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Asenapine: a review of acute and extension phase data in bipolar disorder.
CNS neuroscience & therapeutics, 2010Co-Authors: Roger S. McintyreAbstract:The second generation atypical antipsychotic, Asenapine (Saphris), was approved by the US FDA (August 2009) for the acute treatment of manic or mixed episodes with or without psychotic features associated with bipolar I disorder in adults as well as the acute treatment of schizophrenia. Asenapine exhibits a high affinity for and antagonism at several serotonergic (5-HT(2A-C), 5HT(5A), 5HT(6), 5HT(7)), dopaminergic (D(2), D(3)), alpha-adrenergic (α(1) and α(2)), and histaminergic (H1, H2) receptor subtypes. Asenapine is the first atypical antipsychotic formulated as a fast-dissolving, rapidly absorbed sublingual tablet. Asenapine was evaluated in adults with bipolar I disorder, manic or mixed episodes with or without psychotic features. Two identically designed 3-week registration trials confirmed the efficacy of Asenapine relative to placebo in studies that included olanzapine as an active control. The placebo-subtracted rate of EPS (excluding akathisia) is 5% whereas the placebo-subtracted rate of akathisia was 2%. The placebo-subtracted rate of clinically significant weight gain (≥7%) with Asenapine was approximately 5% during the 3-week acute mania trials. A 9- extension trial indicated that 19% of Asenapine patients will experience clinically significant weight gain. Clinically significant metabolic abnormalities were not observed during the acute and/or extension trials. Asenapine can be associated with somnolence (Asenapine 24%, placebo 6%) and does not appear to be associated with clinically significant changes in vital signs, laboratory parameters, or electrocardiographic changes. Bipolar depression and recurrence prevention studies are required to fully characterize this novel agent's position in the treatment of bipolar disorder.
Mary Mackle - One of the best experts on this subject based on the ideXlab platform.
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Asenapine for the treatment of adults with an acute exacerbation of schizophrenia results from a randomized double blind fixed dose placebo controlled trial with olanzapine as an active control
Cns Spectrums, 2017Co-Authors: Ronald P. Landbloom, Mary Mackle, Roger S. Mcintyre, Maju Mathews, Linda J Kelly, Linda Snowadami, Carla HundtAbstract:Objective Evaluate the efficacy and safety of Asenapine 2.5 mg twice daily (bid; n=97) or 5 mg bid (n=113) versus placebo (n=101) in adults with acute exacerbation of schizophrenia. Methods Adults with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia diagnosis were randomized to Asenapine 2.5 mg bid, 5 mg bid, placebo, or olanzapine 15 mg once daily. The primary objective was to test superiority of Asenapine versus placebo as measured by the change from baseline to day 42 in the Positive and Negative Syndrome Scale (PANSS) total score. The key safety objective was to evaluate weight change in Asenapine versus olanzapine at day 42. Results The primary efficacy endpoint was met; the difference in least squares mean change from baseline to day 42 in PANSS total score between Asenapine 5 mg bid and placebo was −5.5 points (unadjusted 95% CI: −10.1, −1.0; multiplicity adjusted P=0.0356). Neither Asenapine 2.5 mg bid nor olanzapine 15mg were superior to placebo. Both Asenapine groups demonstrated significantly less weight gain than olanzapine at day 42. Significantly higher incidences of oral hypoesthesia and dysgeusia (combined) for Asenapine 2.5 mg bid (5.2% vs 0.0%; P=0.0217) and 5 mg bid (7.1% vs 0.0%; P=0.0033) were observed versus placebo. There were no significant differences between Asenapine and placebo for insomnia, extrapyramidal symptoms, akathisia, dizziness, or combination of somnolence/sedation/hypersomnia. Conclusion This study supports previous efficacy and safety findings of Asenapine; Asenapine 5 mg bid is the lowest effective dose in adults with schizophrenia. Asenapine was associated with significantly less weight gain than olanzapine at day 42.
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Exploring the long-term safety of Asenapine in adults with schizophrenia in a double-blind, fixed-dose, extension study.
Neuropsychiatric disease and treatment, 2017Co-Authors: Suresh Durgam, Mary Mackle, Ronald P. Landbloom, Maju Mathews, Henry A. NasrallahAbstract:Purpose The primary objective of this study was to assess long-term safety with sublingual Asenapine 2.5 or 5 mg twice daily (BID) in patients with schizophrenia. Patients and methods Actively treated patients on Asenapine 2.5 mg BID, Asenapine 5 mg BID, or olanzapine 15 mg once daily (QD) who completed a 6-week randomized, double-blind, placebo- and olanzapine-controlled study continued lead-in treatment in this 26-week, multicenter, double-blind, double-dummy, olanzapine-controlled Phase IIIB extension study; placebo patients were assigned to Asenapine 2.5 mg BID treatment. Safety analyses were based on the all treated set (patients who received one or more doses of extension trial medication); change from baseline analyses used the acute study baseline. Treatment-emergent adverse events (TEAEs) and changes in laboratory parameters were monitored; weight change for Asenapine versus olanzapine was the key secondary objective. Descriptive statistics were used; weight change was analyzed using a mixed-model repeated-measure approach. Results Of the 120 patients in the all-treated set, 60% completed treatment (Asenapine 2.5 mg BID 66.1% overall, Asenapine 5 mg BID 52.4%, olanzapine 15 mg QD 56.3%). The incidence of TEAEs was higher for placebo patients from the lead-in study who switched to Asenapine 2.5 mg BID for extension treatment (71.0%) versus patients continuing Asenapine 2.5 mg BID (38.7%), Asenapine 5 mg BID (38.1%), or olanzapine 15 mg QD (25.0%). The most common TEAE (≥5% in every group) was worsening of schizophrenia. Least squares mean change in body weight from the acute study baseline to week 26 was +0.6 kg for overall Asenapine 2.5 mg BID, +0.8 kg for Asenapine 5 mg BID, and +1.2 kg for olanzapine 15 mg QD. There were no clinically relevant changes in metabolic parameters; values were generally similar across treatment groups. Conclusion Asenapine 2.5 mg BID and 5 mg BID were generally well tolerated in long-term treatment. Weight gain was less for overall Asenapine 2.5 mg BID and 5 mg BID than for olanzapine 15 mg QD.
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Asenapine efficacy and safety of 5 and 10 mg bid in a 3 week randomized double blind placebo controlled trial in adults with a manic or mixed episode associated with bipolar i disorder
Journal of Affective Disorders, 2016Co-Authors: Ronald L Landbloom, Mary Mackle, Roger S. Mcintyre, Maju Mathews, Linda J Kelly, Linda Snowadami, Carla HundtAbstract:Abstract Background Asenapine is an atypical antipsychotic for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The recommended Asenapine starting dose is 10 mg bid with the option to reduce the dose to 5 mg bid if needed due to adverse effects/tolerability. Methods Phase IIIb, international, double-blind, fixed-dose, parallel-group, 3-week placebo-controlled trial of Asenapine 5 and 10 mg bid in adults with an acute bipolar I disorder manic or mixed episode. Primary outcome was difference in Asenapine versus placebo in mean change from baseline to day 21 in the Young-Mania Rating Scale (YMRS) total score. Others included difference in Asenapine versus placebo in the Clinical Global Impression Scale for Bipolar Severity (CGI-BP-S) and rate of YMRS responders. Results Both Asenapine doses were statistically superior to placebo in mean change from baseline to day 21 in YMRS total score (−10.9, −14.4, and −14.9 for placebo, Asenapine 5 mg bid, 10 mg bid, respectively). Both Asenapine doses had statistically superior improvement in mean change in CGI-BP-S score at day 21. Neither Asenapine dose had significantly more YMRS responders at day 21 than placebo. Limitations Results may not be generalizable to the entire population with bipolar I disorder owing to strict inclusion criteria. Conclusions This study evaluated, by a fixed-dose design, the efficacy and safety of Asenapine versus placebo in patients with bipolar I disorder. Both Asenapine 5 and 10 mg bid were efficacious in treating mania associated with bipolar I disorder and were generally well tolerated.
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Asenapine for the Acute Treatment of Pediatric Manic or Mixed Episode of Bipolar I Disorder.
Journal of the American Academy of Child and Adolescent Psychiatry, 2015Co-Authors: Robert L. Findling, Mary Mackle, Armin Szegedi, Ronald L Landbloom, Janelle Koppenhaver, Sabine Braat, Qi Zhu, Kiki D. Chang, Maju MathewsAbstract:Objective To evaluate Asenapine versus placebo in 403 patients aged 10 to 17 years with bipolar I disorder currently in manic or mixed episodes. Method In this double-blind, placebo-controlled, international trial, patients were randomized 1:1:1:1 to placebo, Asenapine 2.5, 5, or 10 mg b.i.d. (twice daily). Primary efficacy measure was change from baseline in Young-Mania Rating Scale (YMRS) total score at day 21. Analyses of patients with/without attention-deficit/hyperactivity disorder (ADHD) and with/without stimulant use were performed. Results The mean difference in Asenapine versus placebo in YMRS was –3.2 ( p = .0008), –5.3 ( p p p Conclusion All Asenapine doses versus placebo were superior based on change in YMRS at day 21. Asenapine was generally well tolerated in patients aged 10 to 17 years with bipolar I disorder in manic or mixed states. Increases in weight and fasting insulin were associated with Asenapine. Clinical trial registration information— Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder; http://clinicaltrials.gov ; NCT01244815 .
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safety and efficacy from an 8 week double blind trial and a 26 week open label extension of Asenapine in adolescents with schizophrenia
Journal of Child and Adolescent Psychopharmacology, 2015Co-Authors: Robert L. Findling, Mary Mackle, Ronald P. Landbloom, Carla Hundt, Sabine Braat, Wendi Pallozzi, Marianne Z Wamboldt, Maju MathewsAbstract:Abstract Objective: The purpose of this study was to evaluate the safety and efficacy of Asenapine in adolescents with schizophrenia. Methods: In an 8 week, randomized, double-blind placebo-controlled trial, subjects (12–17 years of age) meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria for schizophrenia were randomized 1:1:1 to placebo, Asenapine 2.5 mg b.i.d., or Asenapine 5 mg b.i.d. Subjects who completed the 8 week acute study could participate in a 26 week flexible-dose Asenapine-only open-label extension (OLE). Results: A similar percentage of subjects completed treatment on day 56 (2.5 mg b.i.d. (n=98): 83%; 5 mg b.i.d. [n=106]: 79%; placebo [n=102]: 79%). In the mixed model for repeated measures analysis of the primary end-point (with Hochberg correction for multiplicity), least squares (LS) mean differences between Asenapine and placebo on the Positive and Negative Syndrome Scale (PANSS) total score at day 56 were not significant (−4.8 for...
