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https://www.readbyqxmd.com/read/27821210/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
#1
Ronald Landbloom, Mary Mackle, Xiao Wu, Linda Kelly, Linda Snow-Adami, Roger S McIntyre, Maju Mathews, Carla Hundt
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...
November 8, 2016: CNS Spectrums
https://www.readbyqxmd.com/read/27756486/repeated-asenapine-treatment-does-not-participate-in-the-mild-stress-induced-fosb-%C3%AE-fosb-expression-in-the-rat-hypothalamic-paraventricular-nucleus-neurons
#2
Alexander Kiss, Zuzana Majercikova
Effect of repeated asenapine (ASE) treatment on FosB/ΔFosB expression was studied in the hypothalamic paraventricular nucleus (PVN) of male rats exposed to chronic mild stress (CMS) for 21days. Our intention was to find out whether repeated ASE treatment for 14days may: 1) induce FosB/ΔFosB expression in the PVN; 2) activate selected PVN neuronal phenotypes, synthesizing oxytocin (OXY), vasopressin (AVP), corticoliberin (CRH) or tyrosine hydroxylase (TH); and 3) interfere with the impact of CMS. Control, ASE, CMS, and CMS+ASE treated groups were used...
October 15, 2016: Neuropeptides
https://www.readbyqxmd.com/read/27755982/long-term-safety-and-tolerability-of-asenapine-a-double-blind-uncontrolled-long-term-extension-trial-in-adults-with-an-acute-manic-or-mixed-episode-associated-with-bipolar-i-disorder
#3
Terence A Ketter, Suresh Durgam, Ronald Landbloom, Mary Mackle, Xiao Wu, Maju Mathews
BACKGROUND: Asenapine (ASN) is approved in the United States as monotherapy and adjunctive therapy (to lithium or valproate) in adults with bipolar mania, and as monotherapy in pediatric patients with bipolar mania. This is the first long-term study evaluating safety and tolerability of ASN fixed doses in this population. METHODS: After completing a 3-week, randomized, placebo (PBO)-controlled acute trial, patients could enroll in this 26-week, fixed-dose (5 or 10mg twice daily), double-blind extension study...
October 14, 2016: Journal of Affective Disorders
https://www.readbyqxmd.com/read/27738377/an-open-label-pilot-study-of-adjunctive-asenapine-for-the-treatment-of-posttraumatic-stress-disorder
#4
Patricia Pilkinton, Carlos Berry, Seth Norrholm, Al Bartolucci, Badari Birur, Lori L Davis
OBJECTIVE: Selective serotonin reuptake inhibitors (SSRIs) remain the first-line treatment for posttraumatic stress disorder (PTSD). However, adjunctive atypical antipsychotics are often used to target residual or refractory symptoms. Asenapine is a novel atypical antipsychotic that possesses a high serotonin (5-HT2A) to dopamine (D2) affinity ratio and alpha-adrenergic antagonism, which may be advantageous in treating PTSD. This pilot study aimed to identify the therapeutic potential of asenapine as an adjunctive treatment for PTSD...
August 15, 2016: Psychopharmacology Bulletin
https://www.readbyqxmd.com/read/27727180/do-atypical-antipsychotics-have-antisuicidal-effects-a-hypothesis-generating-overview
#5
Maurizio Pompili, Ross J Baldessarini, Alberto Forte, Denise Erbuto, Gianluca Serafini, Andrea Fiorillo, Mario Amore, Paolo Girardi
Modern antipsychotic drugs are employed increasingly in the treatment of mood disorders as well as psychoses, stimulating interest in their possible contributions to altering suicidal risk. Clozapine remains the only treatment with an FDA-recognized indication for reducing suicidal risk (in schizophrenia). We carried out a systematic, computerized search for reports of studies involving antipsychotic drug treatment and suicidal behaviors. A total of 19 reports provide data with preliminary support for potential suicide risk-reducing effects of olanzapine, quetiapine, ziprasidone, aripiprazole, and asenapine in addition to clozapine, and provide some support for antipsychotic drug treatment in general...
October 11, 2016: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/27663798/risk-and-efficacy-in-cognitive-functions-in-bipolar-disorder-ii-with-atypical-antipsychotic-augmentation
#6
Francesco Franza
BD-II has been consistently associated with cognitive dysfunction across a broad range of cognitive domains. Atypical antipsychotic drugs, or SGAs are effective antipsychotics in these diseases, often in combination with antidepressants and mood stabilizers. Data on the possible effect of antipsychotics on neuro-cognition are rare and conflicting. The main objective of our study was to assess the effectiveness and possible risks to cognitive function in a group of inpatients affected by BD-II. Forty-five inpatients with Bipolar II Disorder (DSM-5) were included in a two-year observational study...
September 2016: Psychiatria Danubina
https://www.readbyqxmd.com/read/27625143/pharmacodynamic-and-pharmacokinetic-investigation-of-cyclodextrin-mediated-asenapine-maleate-in-situ-nasal-gel-for-improved-bioavailability
#7
Juilee A Kulkarni, Amelia M Avachat
Asenapine maleate (AM) is used in the treatment of schizophrenia. Its oral and sublingual bioavailability is <2% and 35%, respectively, due to first pass metabolism and poor solubility. To avoid first pass metabolism and to enhance solubility at all nasal pH conditions, thermo-responsive in situ nasal gel containing asenapine maleate-hydroxyl propyl β cyclodextrin inclusion complex (AM-HPβCD) was prepared in the present study. Inclusion complex (1:1 molar ratio) was characterized using UV spectroscopy, FITR and XRD techniques...
October 16, 2016: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/27542594/impact-of-repeated-asenapine-treatment-on-fosb-%C3%AE-fosb-expression-in-the-forebrain-structures-under-normal-conditions-and-mild-stress-preconditioning-in-the-rat
#8
Zuzana Majercikova, Lubica Horvathova, Jana Osacka, Jan Pecenak, Alexander Kiss
Long-term effect of asenapine (ASE), an atypical antipsychotic drug, on FosB/ΔFosB quantitative variations in the striatum, septum, nucleus accumbens, and prefrontal cortex, was light microscopically evaluated in normal rats and rats preconditioned with chronic unpredictable mild stress (CMS). CMS included restraint, social isolation, crowding, swimming, and cold. The rats were exposed to CMS for 21 days. From the 7th day of CMS, the rats were injected subcutaneously with saline (300μl/rat) or ASE (0.3mg/kg b...
August 16, 2016: Brain Research Bulletin
https://www.readbyqxmd.com/read/27461426/long-term-safety-of-asenapine-in-pediatric-patients-diagnosed-with-bipolar-i-disorder-a-50-week-open-label-flexible-dose-trial
#9
Robert L Findling, Ronald L Landbloom, Mary Mackle, Xiao Wu, Linda Snow-Adami, Kiki Chang, Suresh Durgam
BACKGROUND: Sublingually administered asenapine was approved in March 2015 by the United States Food and Drug Administration for patients aged 10-17 years with an acute manic or mixed episode associated with bipolar I disorder (BP-1). This is the first long-term safety and tolerability study of asenapine in this population. METHODS: Following the 3-week randomized, double-blind, placebo-controlled trial of patients aged 10-17 years with an acute manic or mixed episode associated with BP-1, patients could enroll in this flexible-dose (2...
October 2016: Paediatric Drugs
https://www.readbyqxmd.com/read/27372312/antipsychotic-drug-induced-somnolence-incidence-mechanisms-and-management
#10
REVIEW
Fang Fang, Hongwei Sun, Zuowei Wang, Ming Ren, Joseph R Calabrese, Keming Gao
Somnolence is a common side effect of antipsychotics. To assess the incidence of this side effect, we performed a MEDLINE search for randomized, double-blinded, placebo- or active-controlled studies of adult patients treated with antipsychotics for schizophrenia, mania, bipolar depression, or bipolar disorder. We extracted rates of somnolence from original publications and pooled them based on the dose of each antipsychotic in the same psychiatric condition, then estimated the absolute risk increase (ARI) and the number needed to harm (NNH) of an antipsychotic relative to placebo or an active comparator in the same psychiatric condition...
September 2016: CNS Drugs
https://www.readbyqxmd.com/read/27356921/asenapine-a-review-in-schizophrenia
#11
Greg L Plosker, Emma D Deeks
Asenapine (Saphris(®), Sycrest(®)) is an atypical antipsychotic that is administered sublingually twice daily and is approved for schizophrenia in the USA, Japan and other countries, but not in the EU. This article reviews the pharmacology, clinical efficacy and tolerability profile of asenapine in the treatment of adults with schizophrenia. Clinical trials with asenapine have demonstrated efficacy in terms of both positive and negative symptoms of schizophrenia, although findings have not always been consistent...
July 2016: CNS Drugs
https://www.readbyqxmd.com/read/27347638/an-update-of-safety-of-clinically-used-atypical-antipsychotics
#12
L Orsolini, C Tomasetti, A Valchera, R Vecchiotti, I Matarazzo, F Vellante, F Iasevoli, E F Buonaguro, M Fornaro, A L C Fiengo, G Martinotti, M Mazza, G Perna, A Carano, A De Bartolomeis, M Di Giannantonio, D De Berardis
INTRODUCTION: The atypical antipsychotic (APs) drugs have become the most widely used agents to treat a variety of psychoses because of their superiority with regard to safety and tolerability profile compared to conventional/'typical' APs. AREAS COVERED: We aimed at providing a synthesis of most current evidence about the safety and tolerability profile of the most clinically used atypical APs so far marketed. Qualitative synthesis followed an electronic search made inquiring of the following databases: MEDLINE, Embase, PsycINFO and the Cochrane Library from inception until January 2016, combining free terms and MESH headings for the topics of psychiatric disorders and all atypical APs as following: ((safety OR adverse events OR side effects) AND (aripiprazole OR asenapine OR quetiapine OR olanzapine OR risperidone OR paliperidone OR ziprasidone OR lurasidone OR clozapine OR amisulpride OR iloperidone))...
October 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27321864/the-effects-of-second-generation-antipsychotic-drugs-on-sleep-variables-in-healthy-subjects-and-patients-with-schizophrenia
#13
Jaime M Monti, Pablo Torterolo, Seithikurippu R Pandi Perumal
Insomnia is a common feature in schizophrenia, and is characterized by an increase of sleep latency (SL), as well as reductions in total sleep time (TST) and sleep efficiency (SE). Regarding sleep architecture, non-rapid-eye-movement (NREM) sleep, slow wave sleep (SWS) and rapid-eye-movement (REM) sleep latency are decreased, whereas REM sleep tends to remain unchanged. According to polysomnographic studies, clozapine, olanzapine, quetiapine and ziprasidone administration increased TST and/or SE in healthy subjects...
May 15, 2016: Sleep Medicine Reviews
https://www.readbyqxmd.com/read/27271087/efficacy-and-safety-of-asenapine-in-asian-patients-with-an-acute-exacerbation-of-schizophrenia-a-multicentre-randomized-double-blind-6-week-placebo-controlled-study
#14
Toshihiko Kinoshita, Ya-Mei Bai, Jong-Hoon Kim, Mutsuo Miyake, Nobuyuki Oshima
RATIONALE: Asenapine is a second generation anti-psychotic approved in the USA in 2009 for the treatment of schizophrenia, but its efficacy has not been proven in Asian patients. OBJECTIVES: The objectives of this study are to evaluate the efficacy and tolerability of asenapine in Asian patients experiencing an acute exacerbation of schizophrenia. METHODS: In this prospective, double-blind study, patients in Japan, Korea, and Taiwan were randomized (1:1:1) to asenapine 5 mg twice daily (bid), 10 mg bid or placebo for 6 weeks after a 3- to 7-day washout/screening period...
July 2016: Psychopharmacology
https://www.readbyqxmd.com/read/27222264/current-trends-on-antipsychotics-focus-on-asenapine
#15
REVIEW
Donatella Marazziti, Armando Piccinni, Stefano Baroni, Francesco Mungai, Silvio Presta, Federico Mucci, Liliana Dell'Osso
Over the years, both first- (FGAs) and second-generation antipsychotics (SGAs), continue to gain increasing evidence of being effective in the treatment of psychotic symptoms. Currently, they represent the first-line treatment of schizophrenia and bipolar disorder, although they are widely used in psychotic depression and other clinical conditions, such as agitation and/or behavioural disturbances. Despite representing an indispensable tool for the treatment of severe psychotic disorders, they are widely known to have a number of unwanted side effects that the clinician must be aware of, and handle carefully to provide the patient the best available treatment in the short and long-term...
2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27190616/asenapine-augmentation-in-bipolar-disorders-a-case-series
#16
Donatella Marazziti, Federico Mucci, Stefano Baroni, Armando Piccinni
Asenapine, a novel second-generation antipsychotic is effective in acute treatment of bipolar I disorder patients in combination with mood stabilizers even in resistant cases. Although there is no evidence for asenapine's efficacy to be superior to currently available agents, asenapine's favorable weight and metabolic profile are of clinical interest.
May 2016: Clinical Case Reports
https://www.readbyqxmd.com/read/27177356/preliminary-examination-of-microrna-expression-profiling-in-bipolar-disorder-i-patients-during-antipsychotic-treatment
#17
Chor Hong Lim, Nor Zuraida Zainal, Sharmilla Kanagasundram, Shamsul Mohd Zain, Zahurin Mohamed
Although major progress has been achieved in research and development of antipsychotic medications for bipolar disorder (BPD), knowledge of the molecular mechanisms underlying this disorder and the action of atypical antipsychotics remains incomplete. The levels of microRNAs (miRNAs)-small non-coding RNA molecules that regulate gene expression, including genes involved in neuronal function and plasticity-are frequently altered in psychiatric disorders. This study aimed to examine changes in miRNA expression in bipolar mania patients after treatment with asenapine and risperidone...
September 2016: American Journal of Medical Genetics. Part B, Neuropsychiatric Genetics
https://www.readbyqxmd.com/read/27154343/asenapine-induced-acute-dystonia-in-an-adolescent-male
#18
Dhrubajyoti Bhuyan, Soumitra Ghosh, Arnab Bhattacharya, Samir Kumar Praharaj
Asenapine is a sublingually absorbed newer second-generation antipsychotic that is approved for the treatment of schizophrenia and bipolar disorder in patients, with a lower extrapyramidal adverse effect potential. We report an adolescent boy having schizophrenia who developed an acute dystonic reaction after 4 days when the dose of asenapine was increased from 10 to 15 mg per day.
May 6, 2016: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/27142747/nutrient-induced-glucagon-like-peptide-1-release-is-modulated-by-serotonin
#19
Dina Ripken, Nikkie van der Wielen, Heleen M Wortelboer, Jocelijn Meijerink, Renger F Witkamp, Henk F J Hendriks
Glucagon like peptide-1 (GLP-1) and serotonin are both involved in food intake regulation. GLP-1 release is stimulated upon nutrient interaction with G-protein coupled receptors by enteroendocrine cells (EEC), whereas serotonin is released from enterochromaffin cells (ECC). The central hypothesis for the current study was that nutrient-induced GLP-1 release from EECs is modulated by serotonin through a process involving serotonin receptor interaction. This was studied by assessing the effects of serotonin reuptake inhibition by fluoxetine on nutrient-induced GLP-1, PYY and CCK release from isolated pig intestinal segments...
June 2016: Journal of Nutritional Biochemistry
https://www.readbyqxmd.com/read/27130879/development-and-validation-of-a-stability-indicating-rp-hplc-method-by-a-statistical-optimization-process-for-the-quantification-of-asenapine-maleate-in-lipidic-nanoformulations
#20
Renuka S Managuli, Lalit Kumar, Ankita D Chonkar, Rupesh K Shirodkar, Shaila Lewis, Kunnatur B Koteshwara, Meka Sreenivasa Reddy, Srinivas Mutalik
A stability-indicating RP-HPLC method was developed for quantification of asenapine maleate (ASPM) in lipid nanoformulations. The proposed method was used to assess intrinsic stability of ASPM by conducting force degradation study. The results indicated no considerable degradation of ASPM on subjecting it to hydrolytic, oxidative, thermal and photolytic stresses. The method was validated according to ICH Q2(R1) guidelines by employing Full factorial design using Design-Expert(®) software. ASPM was precisely and accurately quantified in nanoparticles by separating it on Hyperclone BDS C18 using 80-20% v/v mixture of potassium phosphate solution containing 0...
September 2016: Journal of Chromatographic Science
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