Antipsychotic Medications Age and Step Therapy
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Original Research Published, Reproduced, Transmitted, Modified, Posted, Sold, Licensed, Or Used for Commercial Purposes
This work may not be copied, distributed, displayed, Original Research published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the Efficacy and Effectiveness of Depot publisher’s Terms & Conditions. Versus Oral Antipsychotics in Schizophrenia: Synthesizing Results Across Different Research Designs Noam Y. Kirson, PhD; Peter J. Weiden, MD; Sander Yermakov, MS; Wayne Huang, MPP; Thomas Samuelson, BA; Steve J. Offord, PhD; Paul E. Greenberg, MS, MA; and Bruce J. O. Wong, MD ABSTRACT he cornerstone of long-term maintenance therapy Objective: Nonadherence is a major challenge in schizophrenia Tof schizophrenia patients is relapse prevention. treatment. While long-acting (depot) antipsychotic medications are Relapse prevention is necessary—albeit not sufficient— often recommended to address adherence problems, evidence on for eventual successful rehabilitation.1 In practice, the the comparative effectiveness of depot versus oral antipsychotics is effectiveness of maintenance antipsychotic treatment is inconsistent. We hypothesize that this inconsistency could be due to often undermined by poor adherence to therapy. Not systematic differences in study design. This review evaluates the effect only is nonadherence the single greatest modifiable of study design on the comparative effectiveness of antipsychotic risk factor for relapse,2,3 it is also often undetected, formulations. The optimal use of different antipsychotic formulations resulting in lost opportunities to employ psychosocial in a general clinical setting depends on better understanding of the underlying reasons for differences in effectiveness across research interventions for adherence, as well as uncertainty as designs. to the relative contribution of lack of efficacy versus Data Sources: A PubMed literature review targeted English-language adherence problems to poor outcomes. -
When Clozapine Is Not Tolerated Mitchell J
University of North Dakota UND Scholarly Commons Nursing Capstones Department of Nursing 10-28-2018 When Clozapine is Not Tolerated Mitchell J. Relf Follow this and additional works at: https://commons.und.edu/nurs-capstones Recommended Citation Relf, Mitchell J., "When Clozapine is Not Tolerated" (2018). Nursing Capstones. 268. https://commons.und.edu/nurs-capstones/268 This Independent Study is brought to you for free and open access by the Department of Nursing at UND Scholarly Commons. It has been accepted for inclusion in Nursing Capstones by an authorized administrator of UND Scholarly Commons. For more information, please contact [email protected]. Running head: WHEN CLOZAPINE IS NOT TOLERATED 1 WHEN CLOZAPINE IS NOT TOLERATED by Mitchell J. Relf Masters of Science in Nursing, University of North Dakota, 2018 An Independent Study Submitted to the Graduate Faculty of the University of North Dakota in partial fulfillment of the requirements for the degree of Master of Science Grand Forks, North Dakota December 2018 WHEN CLOZAPINE IS NOT TOLERATED 2 PERMISSION Title When Clozapine is Not Tolerated Department Nursing Degree Master of Science In presenting this independent study in partial fulfillment of the requirements for a graduate degree from the University of North Dakota, I agree that the College of Nursing and Professional Disciplines of this University shall make it freely available for inspection. I further agree that permission for extensive copying or electronic access for scholarly purposes may be granted by the professor who supervised my independent study work or, in her absence, by the chairperson of the department or the dean of the School of Graduate Studies. -
Treatment of Psychosis: 30 Years of Progress
Journal of Clinical Pharmacy and Therapeutics (2006) 31, 523–534 REVIEW ARTICLE Treatment of psychosis: 30 years of progress I. R. De Oliveira* MD PhD andM.F.Juruena MD *Department of Neuropsychiatry, School of Medicine, Federal University of Bahia, Salvador, BA, Brazil and Department of Psychological Medicine, Institute of Psychiatry, King’s College, University of London, London, UK phrenia. Thirty years ago, psychiatrists had few SUMMARY neuroleptics available to them. These were all Background: Thirty years ago, psychiatrists had compounds, today known as conventional anti- only a few choices of old neuroleptics available to psychotics, and all were liable to cause severe extra them, currently defined as conventional or typical pyramidal side-effects (EPS). Nowadays, new antipsychotics, as a result schizophrenics had to treatments are more ambitious, aiming not only to suffer the severe extra pyramidal side effects. improve psychotic symptoms, but also quality of Nowadays, new treatments are more ambitious, life and social reinsertion. We briefly but critically aiming not only to improve psychotic symptoms, outline the advances in diagnosis and treatment but also quality of life and social reinsertion. Our of schizophrenia, from the mid 1970s up to the objective is to briefly but critically review the present. advances in the treatment of schizophrenia with antipsychotics in the past 30 years. We conclude DIAGNOSIS OF SCHIZOPHRENIA that conventional antipsychotics still have a place when just the cost of treatment, a key factor in Up until the early 1970s, schizophrenia diagnoses poor regions, is considered. The atypical anti- remained debatable. The lack of uniform diagnostic psychotic drugs are a class of agents that have criteria led to relative rates of schizophrenia being become the most widely used to treat a variety of very different, for example, in New York and psychoses because of their superiority with London, as demonstrated in an important study regard to extra pyramidal symptoms. -
Lumateperone Monograph
Lumateperone (Caplyta®) Classification Atypical antipsychotic Pharmacology The mechanism of action of lumateperone tosylate (Caplyta, ITI-007) in the treatment of schizophrenia is unknown but it’s thought to simultaneously modulate serotonin, dopamine, and glutamate neurotransmission. Specifically, lumateperone acts as a potent 5-HT2A receptor antagonist, a D2 receptor presynaptic partial agonist and postsynaptic antagonist, a D1 receptor-dependent modulator of glutamate, and a serotonin reuptake inhibitor. Indication Treatment of schizophrenia in adults Boxed Warning Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Caplyta is not approved for the treatment of patients with dementia-related psychosis. Pharmacokinetics Pharmacokinetic Parameter Details Absorption Rapidly absorbed. Absolute bioavailability is about 4.4%. Cmax reached approximately 1 (fasting) to 2 h (food) post dosing. Ingestion of high fat meal lowers mean Cmax by 33% and increases mean AUC by 9% Distribution Protein binding = 97.4%. Volume of distribution (IV) = 4.1 L/kg Metabolism Extensively metabolized. T1/2 = 13-21 hours for lumateperone and metabolites Excretion Less than 1% excreted unchanged in urine 1 Texas Health and Human Services ● hhs.texas.gov Dosage/Administration 42 mg by mouth once daily with food. Dose titration is not required. Use in Special Population Pregnancy Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Available data from Caplyta use in pregnant women are insufficient to establish any drug associated risks for birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including Caplyta, during pregnancy. -
Lurasidone (Latuda) Reference Number: CP.PMN.50 Effective Date: 09.01.15 Last Review Date: 02.21 Line of Business: Commercial, HIM, Medicaid Revision Log
Clinical Policy: Lurasidone (Latuda) Reference Number: CP.PMN.50 Effective Date: 09.01.15 Last Review Date: 02.21 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Lurasidone (Latuda®) is an atypical antipsychotic. FDA Approved Indication(s) Latuda is indicated for the treatment of: • Schizophrenia in adults and adolescents (13 to 17 years) • Depressive episode associated with bipolar I disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy • Depressive episode associated with bipolar I disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Latuda is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Bipolar Disorder (must meet all): 1. Diagnosis of bipolar disorder; 2. Age ≥ 10 years; 3. Failure of two preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) at up to maximally indicated doses, each used for ≥ 4 weeks, unless all are contraindicated or clinically significant adverse effects are experienced; 4. Dose does not exceed 120 mg per day for adults and 80 mg per day for pediatric patients. Approval duration: Medicaid/HIM – 12 months Commercial – Length of Benefit B. Schizophrenia (must meet all): 1. Diagnosis of schizophrenia; 2. Age ≥ 13 years; 3. Failure of two preferred atypical antipsychotics (e.g., aripiprazole, ziprasidone, quetiapine, risperidone, or olanzapine) at up to maximally indicated doses, each used Page 1 of 6 CLINICAL POLICY Lurasidone for ≥ 4 weeks, unless all are contraindicated or clinically significant adverse effects are experienced; 4. -
Atypical Antipsychotics TCO 02.2018
Therapeutic Class Overview Atypical Antipsychotics INTRODUCTION • Antipsychotic medications have been used for over 50 years to treat schizophrenia and a variety of other psychiatric disorders (Miyamato et al 2005). • Antipsychotic medications generally exert their effect in part by blocking dopamine (D)-2 receptors (Jibson et al 2017). • Antipsychotics are divided into 2 distinct classes based on their affinity for D2 and other neuroreceptors: typical antipsychotics, also called first-generation antipsychotics (FGAs), and atypical antipsychotics, also called second- generation antipsychotics (SGAs) (Miyamato et al 2005). • Atypical antipsychotics do not have a uniform pharmacology or mechanism of action; these differences likely account for the different safety and tolerability profiles of these agents (Clinical Pharmacology 2020, Jibson et al 2017). The atypical antipsychotics differ from the early antipsychotics in that they have affinity for the serotonin 5-HT2 receptor in addition to D2. Clozapine is an antagonist at all dopamine receptors (D1-5), with lower affinity for D1 and D2 receptors and high affinity for D4 receptors. Aripiprazole and brexpiprazole act as partial agonists at the D2 receptor, functioning as an ○ agonist when synaptic dopamine levels are low and as an antagonist when they are high. Cariprazine is a partial agonist at D2 and D3. Pimavanserin does not have dopamine blocking activity and is primarily an inverse agonist at 5-HT2A receptors. The remaining atypical antipsychotics share the similarity of D2 and 5-HT2A -
Schizophrenia Care Guide
August 2015 CCHCS/DHCS Care Guide: Schizophrenia SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT GOALS ALERTS Minimize frequency and severity of psychotic episodes Suicidal ideation or gestures Encourage medication adherence Abnormal movements Manage medication side effects Delusions Monitor as clinically appropriate Neuroleptic Malignant Syndrome Danger to self or others DIAGNOSTIC CRITERIA/EVALUATION (PER DSM V) 1. Rule out delirium or other medical illnesses mimicking schizophrenia (see page 5), medications or drugs of abuse causing psychosis (see page 6), other mental illness causes of psychosis, e.g., Bipolar Mania or Depression, Major Depression, PTSD, borderline personality disorder (see page 4). Ideas in patients (even odd ideas) that we disagree with can be learned and are therefore not necessarily signs of schizophrenia. Schizophrenia is a world-wide phenomenon that can occur in cultures with widely differing ideas. 2. Diagnosis is made based on the following: (Criteria A and B must be met) A. Two of the following symptoms/signs must be present over much of at least one month (unless treated), with a significant impact on social or occupational functioning, over at least a 6-month period of time: Delusions, Hallucinations, Disorganized Speech, Negative symptoms (social withdrawal, poverty of thought, etc.), severely disorganized or catatonic behavior. B. At least one of the symptoms/signs should be Delusions, Hallucinations, or Disorganized Speech. TREATMENT OPTIONS MEDICATIONS Informed consent for psychotropic -
Management of Side Effects of Antipsychotics
Management of side effects of antipsychotics Oliver Freudenreich, MD, FACLP Co-Director, MGH Schizophrenia Program www.mghcme.org Disclosures I have the following relevant financial relationship with a commercial interest to disclose (recipient SELF; content SCHIZOPHRENIA): • Alkermes – Consultant honoraria (Advisory Board) • Avanir – Research grant (to institution) • Janssen – Research grant (to institution), consultant honoraria (Advisory Board) • Neurocrine – Consultant honoraria (Advisory Board) • Novartis – Consultant honoraria • Otsuka – Research grant (to institution) • Roche – Consultant honoraria • Saladax – Research grant (to institution) • Elsevier – Honoraria (medical editing) • Global Medical Education – Honoraria (CME speaker and content developer) • Medscape – Honoraria (CME speaker) • Wolters-Kluwer – Royalties (content developer) • UpToDate – Royalties, honoraria (content developer and editor) • American Psychiatric Association – Consultant honoraria (SMI Adviser) www.mghcme.org Outline • Antipsychotic side effect summary • Critical side effect management – NMS – Cardiac side effects – Gastrointestinal side effects – Clozapine black box warnings • Routine side effect management – Metabolic side effects – Motor side effects – Prolactin elevation • The man-in-the-arena algorithm www.mghcme.org Receptor profile and side effects • Alpha-1 – Hypotension: slow titration • Dopamine-2 – Dystonia: prophylactic anticholinergic – Akathisia, parkinsonism, tardive dyskinesia – Hyperprolactinemia • Histamine-1 – Sedation – Weight gain -
Sex-Specific Cannabidiol- and Iloperidone-Induced Neuronal Activity Changes in an in Vitro MAM Model System of Schizophrenia
International Journal of Molecular Sciences Article Sex-Specific Cannabidiol- and Iloperidone-Induced Neuronal Activity Changes in an In Vitro MAM Model System of Schizophrenia Rachel-Karson Thériault 1,2,†, Myles St-Denis 1,†, Tristen Hewitt 1,2, Jibran Y. Khokhar 2,3 , Jasmin Lalonde 1,2 and Melissa L. Perreault 2,3,* 1 Department of Molecular and Cellular Biology, University of Guelph, Guelph, ON N1G 2W1, Canada; [email protected] (R.-K.T.); [email protected] (M.S.-D.); [email protected] (T.H.); [email protected] (J.L.) 2 Collaborative Program in Neuroscience, University of Guelph, Guelph, ON N1G 2W1, Canada; [email protected] 3 Department of Biomedical Sciences, University of Guelph, Guelph, ON N1G 2W1, Canada * Correspondence: [email protected]; Tel.: +1-(519)-824-4120 (ext. 52013) † These authors contributed equally to this work. Abstract: Cortical circuit dysfunction is thought to be an underlying mechanism of schizophrenia (SZ) pathophysiology with normalization of aberrant circuit activity proposed as a biomarker for antipsychotic efficacy. Cannabidiol (CBD) shows potential as an adjunctive antipsychotic therapy; however, potential sex effects in these drug interactions remain unknown. In the present study, we sought to elucidate sex effects of CBD coadministration with the atypical antipsychotic iloperidone (ILO) on the activity of primary cortical neuron cultures derived from the rat methylazoxymethanol Citation: Thériault, R.-K.; St-Denis, acetate (MAM) model used for the study of SZ. Spontaneous network activity measurements were M.; Hewitt, T.; Khokhar, J.Y.; Lalonde, J.; Perreault, M.L. Sex-Specific obtained using a multielectrode array at baseline and following administration of CBD or ILO Cannabidiol- and Iloperidone- alone, or combined. -
Revision of Precautions Asenapine Maleate, Aripiprazole, Olanzapine
Published by Translated by Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. Revision of Precautions Asenapine maleate, aripiprazole, olanzapine, quetiapine fumarate, clocapramine hydrochloride hydrate, chlorpromazine hydrochloride, chlorpromazine hydrochloride/promethazine hydrochloride/phenobarbital, chlorpromazine phenolphthalinate, spiperone, zotepine, timiperone, haloperidol, paliperidone, pipamperone hydrochloride, fluphenazine decanoate, fluphenazine maleate, brexpiprazole, prochlorperazine maleate, prochlorperazine mesilate, Pharmaceuticals and Medical Devices Agency Office of Safety I 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan E-mail: [email protected] Published by Translated by Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. propericiazine, bromperidol, perphenazine, perphenazine hydrochloride, perphenazine fendizoate, perphenazine maleate, perospirone hydrochloride hydrate, mosapramine hydrochloride, risperidone (oral drug), levomepromazine hydrochloride, levomepromazine maleate March 27, 2018 Non-proprietary name Asenapine maleate, -
Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment for Schizophrenia in Adult Patients? Kyle J
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Student Dissertations, Theses and Papers Scholarship 2017 Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles Philadelphia College of Osteopathic Medicine Follow this and additional works at: https://digitalcommons.pcom.edu/pa_systematic_reviews Part of the Psychiatry Commons Recommended Citation Knowles, Kyle J., "Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients?" (2017). PCOM Physician Assistant Studies Student Scholarship. 381. https://digitalcommons.pcom.edu/pa_systematic_reviews/381 This Selective Evidence-Based Medicine Review is brought to you for free and open access by the Student Dissertations, Theses and Papers at DigitalCommons@PCOM. It has been accepted for inclusion in PCOM Physician Assistant Studies Student Scholarship by an authorized administrator of DigitalCommons@PCOM. For more information, please contact [email protected]. Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles, PA-S A SELECTIVE EVIDENCE BASED MEDICINE REVIEW In Partial Fulfillment of the Requirements For The Degree of Master of Science In Health Sciences- Physician Assistant Department of Physician Assistant Studies Philadelphia College of Osteopathic Medicine Philadelphia, Pennsylvania December 16, 2016 ABSTRACT OBJECTIVE: The objective of this selective EBM review is to determine whether or not “Is Aristada (aripiprazole lauroxil) a safe and effective treatment for schizophrenia in adult patients?” STUDY DESIGN: Review of three randomized controlled studies. All three trials were conducted between 2014 and 2015. DATA SOURCES: One randomized, controlled trial and two randomized, controlled, double- blind trials found via Cochrane Library and PubMed. -
Inhaled Loxapine Monograph
Inhaled Loxapine Monograph Inhaled Loxapine (ADASUVE) National Drug Monograph February 2015 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. Updates will be made when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. FDA Approval Information Description/Mechanism of Inhaled loxapine is a typical antipsychotic used in the treatment of acute Action agitation associated with schizophrenia and bipolar I disorder in adults. Loxapine’s mechanism of action for reducing agitation in schizophrenia and bipolar I disorder is unknown. Its effects are thought to be mediated through blocking postsynaptic dopamine D2 receptors as well as some activity at the serotonin 5-HT2A receptors. Indication(s) Under Review in Inhaled loxapine is a typical antipsychotic indicated for the acute treatment of this document (may include agitation associated with schizophrenia or bipolar I disorder in adults. off label) Off-label use Agitation related to any other cause not due to schizophrenia and bipolar I disorder. Dosage Form(s) Under 10mg oral inhalation using a new STACCATO inhaler device. Review REMS REMS No REMS Post-marketing Study Required See Other Considerations for additional REMS information Pregnancy Rating C Executive Summary Efficacy Inhaled loxapine was superior to placebo in reducing acute agitation at 2 hours post dose measured by the Positive and Negative Syndrome Scale-Excited Component (PEC) in patients with bipolar I disorder and schizophrenia.