Therapeutic Class Overview Atypical Antipsychotics
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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. -
Serotonin 2A Activation and a Novel Therapeutic Drug
Psychopharmacology (2018) 235:3083–3091 https://doi.org/10.1007/s00213-018-5042-1 THEORETICAL AND METHODOLOGICAL PERSPECTIVE The neuropharmacology of sleep paralysis hallucinations: serotonin 2A activation and a novel therapeutic drug Baland Jalal1 Received: 23 April 2018 /Accepted: 17 September 2018 /Published online: 5 October 2018 # The Author(s) 2018 Abstract Sleep paralysis is a state of involuntary immobility occurring at sleep onset or offset, often accompanied by uncanny Bghost-like^ hallucinations and extreme fear reactions. I provide here a neuropharmacological account for these hallucinatory experiences by evoking the role of the serotonin 2A receptor (5-HT2AR). Research has shown that 5-HT2AR activation can induce visual hallucinations, Bmystical^ subjective states, and out-of-body experiences (OBEs), and modulate fear circuits. Hallucinatory experiences triggered by serotonin—serotonergic (Bpseudo^) hallucinations, induced by hallucinogenic drugs—tend to be Bdream-like^ with the experiencer having insight (Bmeta-awareness^) that he is hallucinating, unlike dopaminergic (Bpsychotic^ and Blife-like^) hallucinations where such insight is lost. Indeed, hallucinatory experiences during sleep paralysis have the classic features of serotonergic hallucinations, and are strikingly similar to perceptual and subjective states induced by hallucinogenic drugs (e.g., lysergic acid diethylamide [LSD] and psilocybin), i.e., they entail visual hallucinations, mystical experiences, OBEs, and extreme fear reactions. I propose a possible mechanism whereby serotonin could be functionally implicated in generating sleep paralysis hallucinations and fear reactions through 5-HT2AR activity. Moreover, I speculate on the role of 5-HT2C receptors vis-à-vis anxiety and panic during sleep paralysis, and the orbitofrontal cortex—rich with 5-HT2A receptors—in influencing visual pathways during sleep paralysis, and, in effect, hallucinations. -
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 -
Drug Use Evaluation: Antipsychotic Utilization in Schizophrenia Patients
© Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Drug Use Evaluation: Antipsychotic Utilization in Schizophrenia Patients Research Questions: 1. How many schizophrenia patients are prescribed recommended first-line second-generation treatments for schizophrenia? 2. How many schizophrenia patients switch to an injectable antipsychotic after stabilization on an oral antipsychotic? 3. How many schizophrenia patients are prescribed 2 or more concomitant antipsychotics? 4. Are claims for long-acting injectable antipsychotics primarily billed as pharmacy or physician administered claims? 5. Does adherence to antipsychotic therapy differ between patients with claims for different routes of administration (oral vs. long-acting injectable)? Conclusions: In total, 4663 schizophrenia patients met inclusion criteria, and approximately 14% of patients (n=685) were identified as treatment naïve without claims for antipsychotics in the year before their first antipsychotic prescription. Approximately 45% of patients identified as treatment naïve had a history of remote antipsychotic use, but it is unclear if antipsychotics were historically prescribed for schizophrenia. Oral second-generation antipsychotics which are recommended as first-line treatment in the MHCAG schizophrenia algorithm were prescribed as initial treatment in 37% of treatment naive patients and 28% of all schizophrenia patients. Recommended agents include risperidone, paliperidone, and aripiprazole. Utilization of parenteral antipsychotics was limited in patients with schizophrenia. Overall only 8% of patients switched from an oral to an injectable therapy within 6 months of their first claim. Approximately, 60% of all schizophrenia patients (n=2512) had claims for a single antipsychotic for at least 12 continuous weeks and may be eligible to transition to a long-acting injectable antipsychotic. -
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 -
Appendix 13C: Clinical Evidence Study Characteristics Tables
APPENDIX 13C: CLINICAL EVIDENCE STUDY CHARACTERISTICS TABLES: PHARMACOLOGICAL INTERVENTIONS Abbreviations ............................................................................................................ 3 APPENDIX 13C (I): INCLUDED STUDIES FOR INITIAL TREATMENT WITH ANTIPSYCHOTIC MEDICATION .................................. 4 ARANGO2009 .................................................................................................................................. 4 BERGER2008 .................................................................................................................................... 6 LIEBERMAN2003 ............................................................................................................................ 8 MCEVOY2007 ................................................................................................................................ 10 ROBINSON2006 ............................................................................................................................. 12 SCHOOLER2005 ............................................................................................................................ 14 SIKICH2008 .................................................................................................................................... 16 SWADI2010..................................................................................................................................... 19 VANBRUGGEN2003 .................................................................................................................... -
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. -
Reviews Insights Into Pathophysiology from Medication-Induced Tremor
Freely available online Reviews Insights into Pathophysiology from Medication-induced Tremor 1* 1 1 1 John C. Morgan , Julie A. Kurek , Jennie L. Davis & Kapil D. Sethi 1 Movement Disorders Program Parkinson’s Foundation Center of Excellence, Department of Neurology, Medical College of Georgia, Augusta, GA, USA Abstract Background: Medication-induced tremor (MIT) is common in clinical practice and there are many medications/drugs that can cause or exacerbate tremors. MIT typically occurs by enhancement of physiological tremor (EPT), but not all drugs cause tremor in this way. In this manuscript, we review how some common examples of MIT have informed us about the pathophysiology of tremor. Methods: We performed a PubMed literature search for published articles dealing with MIT and attempted to identify articles that especially dealt with the medication’s mechanism of inducing tremor. Results: There is a paucity of literature that deals with the mechanisms of MIT, with most manuscripts only describing the frequency and clinical settings where MIT is observed. That being said, MIT emanates from multiple mechanisms depending on the drug and it often takes an individualized approach to manage MIT in a given patient. Discussion: MIT has provided some insight into the mechanisms of tremors we see in clinical practice. The exact mechanism of MIT is unknown for most medications that cause tremor, but it is assumed that in most cases physiological tremor is influenced by these medications. Some medications (epinephrine) that cause EPT likely lead to tremor by peripheral mechanisms in the muscle (b-adrenergic agonists), but others may influence the central component (amitriptyline). -
Lurasidone for Schizophrenia
Out of the Pipeline Lurasidone for schizophrenia Jana Lincoln, MD, and Aveekshit Tripathi, MD Table 1 n October 2010, the FDA approved lur- A new atypical asidone for the acute treatment of schizo- Lurasidone: Fast facts antipsychotic phrenia at a dose of 40 or 80 mg/d ad- offers once-daily I Brand name: Latuda ministered once daily with food (Table 1). dosing and is well Indication: Schizophrenia in adults tolerated and How it works Approval date: October 28, 2010 Although the drug’s exact mechanism of ac- Availability date: February 2011 considered weight tion is not known, it is thought that lurasi- Manufacturer: Sunovion Pharmaceuticals, Inc. neutral done’s antipsychotic properties are related Dosing forms: 40 mg and 80 mg tablets to its antagonism at serotonin 2A (5-HT2A) Recommended dosage: Starting dose: 40 and dopamine D2 receptors.1 mg/d. Maximum dose: 80 mg/d Similar to most other atypical antipsy- chotics, lurasidone has high binding affin- ity for 5-HT2A and D2. Lurasidone has also steady-state concentration is reached within high binding affinity for 5-HT7, 5-HT1A, 7 days.1 Lurasidone is eliminated predomi- and α2C-adrenergic receptors, low affin- nantly through cytochrome P450 (CYP) 3A4 ity for α-1 receptors, and virtually no affin- metabolism in the liver. ity for H1 and M1 receptors (Table 2, page 68). Activity on 5-HT7, 5-HT1A, and α2C- Efficacy adrenergic receptors is believed to enhance Lurasidone’s efficacy for treatment of acute cognition, and 5-HT7 is being studied for a schizophrenia was established in four potential role in mood regulation and sen- 6-week, randomized placebo-controlled clin- sory processing.2,3 Lurasidone’s low activity ical trials.1 The patients were adults (mean on α-1, H1, and M1 receptors suggests a low age: 38.8; range: 18 to 72) who met DSM-IV- risk of orthostatic hypotension, H1-mediat- TR criteria for schizophrenia, didn’t abuse ed sedation and weight gain, and H1- and drugs or alcohol, and had not taken any in- M1-mediated cognitive blunting.