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John Panagides – One of the best experts on this subject based on the ideXlab platform.

  • Asenapine for long term treatment of bipolar disorder a double blind 40 week extension study product news
    African Journal of Psychiatry, 2012
    Co-Authors: Roger S. Mcintyre, Jun Zhao, John Panagides, M. Cohen, Larry Alphs, Thomas A. Macek

    Abstract:

    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, 2012
    Co-Authors: J. Schoemaker, John Panagides, Dieter Naber, P Vrijland, Stet L, Robin Emsley

    Abstract:

    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, 2012
    Co-Authors: Armin Szegedi, Mary Mackle, Jun Zhao, Joseph R Calabrese, L Stet, John Panagides

    Abstract:

    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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Jun Zhao – One of the best experts on this subject based on the ideXlab platform.

  • 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, 2015
    Co-Authors: Michael Berk, Jun Zhao, John Tiller, Lakshmi N Yatham, Gin S Malhi, Emmanuelle Weiller

    Abstract:

    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, 2013
    Co-Authors: David E. Kemp, Mary Mackle, Pilar Cazorla, Jun Zhao, Ronald P. Landbloom, Linda Snow-adami, Armin Szegedi

    Abstract:

    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, 2013
    Co-Authors: Mary Mackle, Pilar Cazorla, Jun Zhao, Armin Szegedi

    Abstract:

    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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Armin Szegedi – One of the best experts on this subject based on the ideXlab platform.

  • 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, 2015
    Co-Authors: Robert L. Findling, Mary Mackle, Armin Szegedi, Ronald L Landbloom, Janelle Koppenhaver, Sabine Braat, Qi Zhu, Kiki D. Chang, Maju Mathews

    Abstract:

    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, 2013
    Co-Authors: David E. Kemp, Mary Mackle, Pilar Cazorla, Jun Zhao, Ronald P. Landbloom, Linda Snow-adami, Armin Szegedi

    Abstract:

    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, 2013
    Co-Authors: Mary Mackle, Pilar Cazorla, Jun Zhao, Armin Szegedi

    Abstract:

    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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