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Rationale of Use Psychotropic Medications

Rationale of Use Psychotropic Medications. ASD and Co-Existing Neuropsychiatric Disorders: Medication and Treatment Part III Review of Current Practice of Medication Treatments & Evidence-Based Medication Treatments for ASD. Many medications have been used

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Rationale of Use Psychotropic Medications

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  1. Rationale of Use Psychotropic Medications ASD and Co-Existing Neuropsychiatric Disorders: Medication and Treatment Part III Review of Current Practice of Medication Treatments & Evidence-Based Medication Treatments for ASD

  2. Many medications have been used in the field of Autism Spectrum Disorder - 1 1.1995 - North Carolina Survey - 1 (N=838) 53% taking some psychotropics, anticonvulsants, or vitamins 2. 1999 - Yale Child Study Center Survey (N=109) 55%of High-Functioning PDD individuals on psychotropics 3. 2002 - North Carolina Survey – 2 (N=1,538) 53.1% taking some psychotropics, anticonvulsants, or vitamins 4. 2003 - Autism Society of Ohio Survey (N=417) 55.4% taking some psychotropics, anticonvulsants, or vitamins 5. 2005 - Ohio Public School Survey (N=353) 51.5% taking some psychotropics and anticonvulsants 6. 2006 - Internet Survey (Autism Society of America & Autism Organization Worldwide) (N=552), 52% taking at least one medication

  3. Many medications have been used in the field of Autism Spectrum Disorder - 2 • 7. 2007 - MedState dataset, under age of 21 years (N=1985), • 83% had at least one drug claim during 2002 • 2008 – Data from Medicaid claims for year 2001 from all 50 states • and Washington DC, among the 60,641 children with ASD, • 56% used at least 1 psychotropic medication • 9. 2009 - A Longitudinal Investigation of Medication Use (N=286) • 70% taking a psychotropic or non-psychotropic medication • 81% taking at lease one medication 4.5 years later • 10. 2009 - Data based on 2001 Medicaid claim (children) (N=43,406) • 58% used at least 1 psychotropic medication • 11% used 3 or more medication classes concurrently • 2010 – Based on a Web-based registry, of the 5,181 children with ASD, • 35% used at least 1 psychotropic medication

  4. Many medications have been used in the field of Autism Spectrum Disorder – 3 12. 2012 – Of the 2853 children identified from the Autism Treatment Network, 27% were taking one or more psychotropic medication. 13. 2012 – All Medicaid-eligible South Carolina Autism & Developmental Disabilities Monitoring Network children with ASD from years 2006 to 2007 (n = 263), 40% used psychotropic medication. 14.2013 – Administrative medical and pharmacy claims data from 2001 to 2009, among 33,565 children with ASD, 64% had a filled prescription for at least 1 psychotropic medication. 15. 2013 – near 3 million children and adolescents who were 17 years or younger from 41 state Medicaid programs (2000-2003), 65% with ASD received a psychotropic medication. 16. 2013 – Data within the Simons Simplex Collection (n = 1,605) showed 41.7% ever used 1 or more psychotropic medication.

  5. Many medications have been used • in the field of Autism Spectrum Disorder – 4 • 17. 2013 – Among 115 children with high-functioning ASD, • 33% was taking psychotropic medication • 2014 - Utah Autism Prevalence Study (n = 129), • 58.9% taking one or more psychotropic medication. • ******************************************************************* • 20 - 30% 31- 40% 41-50% 51- 60% 61- 70% 71-80% > 81% • Number of • Studies 1 3 1 9 3 0 1 • ********************************************************************* • 2014 - In UK, of a cohort of 5,651 (0-24 year olds) identified through • The Health Improvement Network from 1992 to 2008, • 29% received psychotropic drugs.

  6. Many medications have been used in the field of Autism Spectrum Disorder – 5 2014 - Psychopharmacological prescriptions for people with ASD: a multinational study (Children) Estimated prescription rate Europe France 4 Germany 11 Italy 4 Spain 100 UK 63 North America USA 108 Canada 184 South America Mexico 5 Brazil 6 Asia Japan 11

  7. How Do medications Work?

  8. Neurochemical Basis of Medication Therapy What are Neurotransmitters? • Neurotransmitters are chemicals in the brain • Neurotransmitters help nerve cells send and receive messages • These messages can influence mood, cognition, and behavior

  9. Neurotransmitters Functions Dopamine – cognition, motor function, eating, drinking, sexual behavior, neuroendocrine regulation, selective attention Serotonin – body temperature, pain, sensory perception, sleep, sexual behavior, motor function, appetite, neuroendocrine regulation, learning, memory, imune response Epinephrine & Nor-Epinephrine - cardiovascular & respiratory functions, appetite, activity level, arousal, anxiety, attention, stress response, movement, sleep, memory, learning

  10. Overlapping Functions Functional domains Of serotonin and norepinephrine norepinephrine serotonin depressed mood anxiety aches/pains loss energy cognition Aggression Appetite sex Concentration Interest motivation

  11. What May Cause ADHD (Attention Deficit-Hyperactivity Disorder)? Neurotransmitter Theory of ADHD 1) Dopamine Hypothesis 2) Noradrenergic Hypothesis 3) Serotonergic Hypothesis

  12. MECHANISMS of STIMULANTS Ritalin, Concerta, Dexedrine, Adderall -enhance catecholamine (norepinephrine & dopamine) release from sympathetic nerve terminals and inhibition of reuptake in the caudate nucleus

  13. Drug treatment for Depression and Obsessive-compulsive Disorder Not Enough Serotonin Depression/OCD MECHANISMS of SRIs (Serotonin Reuptake Inhibitors) SRIs ( Prozac, Paxil, Celexa, Lexapro, Luvox, Zoloft, Effexor Anafranil, etc.) – Inhibit theserotonins being re-uptaken in the neurons of Central Nervous System (CNS)

  14. Reach Drug Concentration in Blood for Treatment Effect Blood concentration by single dose of a medication

  15. Reach Stable Blood Concentration by Multiple Doses of a Drug

  16. Evidence – Based Medication Treatment Literature Review (1994-2014) • National Library of Medicine (NLM) National Center for Biotecnology Information (NCBI) Entrez PubMed Database Search Key Words: “Autism Spectrum Disorder and Medication Therapy” • Only the Studies carried out in USA

  17. Published Studies of Psychopharmacotherapyof ASD Medications for Comorbid ADHD_______ Methylphenidate (Ritalin) Quintana et al. 1995 Handen et al. 2000 RUPPAN 2005 Posey et al. 2007 Jahromi et al. 2009 Ghuman et al. 2009 Pearson et al. 2013 Atomoxetine (Strattera) Jou et al. 2005 Arnold et al. 2006 Posey et al. 2006

  18. Published Studies of Psychopharmacotherapyof ASD Medications for Comorbid ADHD_______ Psychostimulants Stigler et al. 2004 Nickels et al. 2008 Clonidine (Catapres) Koshes and Rock 1994 Ming et al. 2008 Guanfacine (Tenet) Posey et al. 2004 Scahill et al. 2006 Handen et al. 2008

  19. Published Studies of Psychopharmacotherapyof ASD Medications for Sleep Problems Melatonin Hayashi 2001 Paavonen et al. 2003 Jan et al. 2004 Giannotti et al. 2006 Garstang and Wallis 2006 Wasdell et al. 2008 Anderson et al. 2008 Braam et al. 2009 Galli-Carminati et al. 2009 Cortesi et al. 2012 Damiani et al. 2014 Medication for Self Injury Naltrexone (Trexan) Akkok 1995 Benjamin et al. 1995 Willemsen-Swinkels et al. 1996 , 1999 Bouvard et al. 1995 Scifo et al. 1996 Kolmen et al. 1995, 1997, 1998 Feldman et al. 1999 Cazzullo et al. 1999 Williams et al. 2000 Good 2006 Wynn & Brunetti, 2009

  20. Published Studies of Psychopharmacotherapyof ASD Medications for Mood Disorder symptoms Lithium Siegel et al. 2014

  21. Published Studies of Psychopharmacotherapyof ASD Medications for ASD symptoms/problems_____ Anticonvulsants Valproic Acid (Divalproex)(Depakote) Plioplys 1994 Childs & Blair 1997 Hollander et al. 2001, 2006, 2010 Hellings et al. 2005 Anagnostou et al. 2006 Topiramate (Topamax) Hardan et al. 2004 Canitano 2005 Mazzone & Ruta 2006 Levetiracetam (Keppra) Rugino and Samsock 2002 Wasserman et al. 2006 Lamotrigine (Lamictal) Belsito et al. 2001

  22. Published Studies of Psychopharmacotherapyof ASD SRI Medications for ASD symptoms/problems Fluvoxamine (Luvox) Sertraline (Zoloft) Harvey and Cooray 1995 Hellings et al. 1996 McDougle et al. 1996 Steingard et al. 1997 Kauffmann et al. 2001 Ozbayrak 1997 Furusho et al. 2001 McDougle et al. 1998 Martin et al. 2003 Miguel et al. 2009 Sugie et al. 2005 Fluoxetine (Prozac) Paroxetine (Paxil) Koshes 1997 Posey et al. 1999 Fastemi et al. 1998 Sasayama et al. 2009 DeLong et al. 1998, 2002 Peral et al. 1999 Hollander et al. 2005 Mouti et al. 2014

  23. Published Studies of Psychopharmacotherapyof ASD SRI Medications for ASD symptoms/problems Citalopram (Celexa) Couturier & Nicolson 2002 Namerow et al. 2003 Volkmar 2009 Escitalopram (Lexapro) Owley et al. 2005, 2010 Venlafaxine (Effexor) Hollander et al. 2000 Carminati et al. 2006 Mirtazapine (Remeron) Posey et al. 2001 Nguyen & Murphy 2001 Albertini et al. 2006 Coskun et al. 2008, 2009

  24. Published Studies of Psychopharmacotherapyof ASD Antipsychotic Medications for ASD symptoms/problems Abilify (Aripiprazol) Staller 2003 Stigler et al. 2004, 2009 Valicenti-McDermott & Demb 2006 Marcus et al. 2009 Owen et al. 2009 Masi et al. 2009 Findling et al. 2014 Clozapine (Clozarill) Zuddas et al. 1996 Chen et al. 2001 Gobbi & Pulvirentil 2001 Lambrey et al. 2010

  25. Published Studies of Psychopharmacotherapyof ASD Antipsychotic Medications for ASD symptoms/problems Olanzapine (Zyprexa) Zaiprasidone (Geodon) Horrigan et al. 1997 McDougle et al. 2002 Malek-Ahmadi & Simons 1998 Cohen et al. 2004 Potenza et al. 1999 , 2001 Duggal 2007 Demb & Roychoudhury 2000 Malone et al. 2007 Malone et al. 2001 Hollander et al. 2006 Quetiapine (Seroquel) Martin et al. 1999 Findling et al. 2004 Corson et al. 2004 Hardan et al. 2005

  26. Published Studies of Psychopharmacotherapy of ASD Shea et al. 2004 RUPPAN 2005 Bober et al. 2005 Rausch et al. 2005 Williams et al. 2006 Luby et al. 2006 Anderson et al. 2007 Pandina et al. 2007 Scahill et al. 2007 Capone et al. 2008 Aman et al. 2008 Hardan et al. 2010 Scahill et al. 2011 Tobiasova et al. 2011 Antipsychotic Medications for ASD symptoms/problems Risperidone (Risperdal) Purdon et al. 1994 Demb 1996 Findling et al. 1997 Perry et al. 1997 McDougle et al. 1995, 1997, 1998, 2005 Horrigan and Barnhill 1997 Nicolson et al. 1998 Schwam et al. 1998 Dartnall et al. 1999 Posey et al. 1999 Malone et al. 2002 McCracken et al. 2002 Caicedo & Williams 2002 Arnold et al. 2003, 2010

  27. Published Studies of Psychopharmacotherapy of ASD As add-on to Risperidone (Risperidal) Treatment Topiramate Rezaei ey al. 2010 Pentoxifylline Akhondzadeh et al. 2010 Memantine Ghaleiha et al. 2013 Celecoxib Asadabadi et al. 2013

  28. Published Studies of Psychopharmacotherapy of ASD Medications for Non-specific ASD Symptoms/Problems Secretin Horvath et al. 1998 Carey et al. 2002 Perry and Bangaru 1998 Sponheim et al. 2002 Sandler et al. 1999 Unis et al. 2002 Chez et al. 2000 Honomichl et al. 2002 Dunn-Geier et al. 2000 Molloy et al. 2002 Robinson 2001 Levy et al. 2003 Coniglio et al. 2001 Coplan et al. 2003 Roberts et al. 2001 Ratliff-Schaub et al. 2005 Lamson and Plaza 2001 Clark 2001 Owley et al. 2001 Lightdale et al. 2001 Corbett et al. 2001

  29. Published Studies of Psychopharmacotherapy of ASD Medications for Anxiety Symptoms/Problems of ASD Buspirone (BuSpar) Hillbrand & Scott 1995 McCormick 1997 Buitelaar 1998

  30. Published Studies of Psychopharmacotherapy of ASD Medications for Non-specific ASD Symptoms/Problems LSD-25 Simmons et al. 1966 L-dopa Ritvo et al. 1971 Vitamin B6 (& magnesium) Rimland et al. 1978 Findling et al. 1997 Kuriyama et al. 2002 Mousain-Bosc et al. 2006 Pyridoxine & magnesium Lelord et al. 1981 Tolbert et al. 1993 Fenfluramine Ritvo et al. 1984 Varley & Holm 1990 August et al. 1984 Oades et al. 1990 Realmuto et al. 1986 Leventhal et al. 1993 Yarbrough et al. 1987 Barthelemy et al. 1989

  31. Published Studies of Psychopharmacotherapy of ASD Medications for Non-specific ASD Symptoms/Problems Halperidol Anderson et al. 1984 Beta-blockers (Propranolol, pronethalol, Inderal) Ratey et al. 1987 Beversdorf et al. 2008 Narayanan et al. 2010 Clomipramine (Anafranil) Gordon et al. 1992, 1993 Brasic et al. 1994 Sanchez et al. 1995, 1996 Brodkin et al. 1997 Remington et al. 2001 Desipramine Gordon et al. 1992, 1993 Clonidine Fankhauser et al. 1992 Jaelskis et al. 1992

  32. Published Studies of Psychopharmacotherapy of ASD Medications for Non-specific ASD Symptoms/Problems Corticosteroid Stefanatos et al. 1995 Mordekar et al. 2009 Immunoglobulin Gupta et al. 1996 Schneider et al. 2006 DelGiudice-Asch et al. 1999 Handen et al. 2009 Pilopys 2000 Niederhofer et al. 2003 Adrenocorticortrophic ORG 2766 (an ACTH-(4-9) analog Buitelaar et al. 1996 Tetrahydrobiopterin Fernell et al. 1997 Danfors et al. 2005 Klaiman et al. 2013

  33. Published Studies of Psychopharmacotherapy of ASD Medications for Non-specific ASD Symptoms/Problems Piracetam Paczynski 1997 Inositol Levine et al. 1997 Famotidine Linday et al. 1997, 2001 Ketamine Bachenberg 1998 N,N-dimethylglycine Bolman & Richmond 1999 Kern et al. 2001 Niaprazine Rossi et al. 1999

  34. Published Studies of Psychopharmacotherapy of ASD Other Medications for ASD Problematic Behaviors Flumazenil Wray et al. 2000 Vancomycin Sandler et al. 2000 Amantadine HCL King et al. 2001 Mirtazapine Posey et al. 2001 Albertini et al. 2006 Nguyen & Murphy 2001 Coskun et al. 2008, 2009 Galantamine (an acetylcholinesterase inhibitor) Niederhofer et al. 2002 Hertzman 2003 Nicolson et al. 2006

  35. Published Studies of Psychopharmacotherapy of ASD Medications for Non-specific ASD Symptoms/Problems L-carnosine supplementation Chez et al. 2002 Lofexidine Niederhofer et al. 2002 GABA-transaminase agonist Cohen 2002 Donepezil Hardan & Handen 2002 Doyle et al. 2006 Cyproheptadine Gudarzi et al. 2002 Akhondzadeh et al. 2004 Thiamine tetrahydrofuryl disulfide Lonsdale et al. 2002

  36. Published Studies of Psychopharmacotherapy of ASD Other Medications for ASD Problematic Behaviors Eicosapentaenoic acid Johnson & Hollander 2003 Tianeptine Niederhofer et al. 2003 Amoxapine Craven-Thuss & Nicolson 2003 Oxytocine Hollander et al. 2003, 2007 Guastella et al. 2010 Andari et al. 2010 Tachibana et al. 2013 D-cycloserine Posey et al. 2004

  37. Published Studies of Psychopharmacotherapy of ASD Other Medications For ASD Problematic Behaviors Rivastignine tartrate-cholinesterase inhibitor Chez et al. 2004 Omega-3 Fatty Acids Bell et al. 2004 Amminger et al. 2007 Politi et al. 2008 Bent et al. 2009 Meiri et al. 2009 Multivitamin/mineral supplement Adams & Holloway 2004 Dextromethorphane (a glutamate antagonist) Woodard et al. 2005, 2007

  38. Published Studies of Psychopharmacotherapy of ASD Other Medications For ASD Problematic Behaviors Combined anti-androgen & anti-heavy metal therapy Geier & Geier 2006 Loxapine Reinblatt et al. 2006 Ramelteon Stigler et al. 2006 Chelation therapy Sinha et al. 2006 Botulinum toxin Monroy & da Fonseca 2006 Nicotinic cholinergic antagnists Lippiello 2006

  39. Published Studies of Psychopharmacotherapy of ASD Other Medications For ASD Problematic Behaviors Spironolactone Bradstreet et al. 2007 Memantine (Namenda) Erickson & Chambers 2006, 2007 Owley et al. 2006 Chez et al. 2007 Tacrine Niederhofer 2007 Glutamate antagonists Niederhofer 2007 Oxcarbazepine Kapetanovic 2007 Pioglitazone Boris et al. 2007

  40. Published Studies of Psychopharmacotherapy of ASD Other Medications For ASD Problematic Behaviors Estrogen Jones & Okere 2008 DMSA Adams et al. 2009 St John’s Wort Niederhofer 2009 Ginkgo Biloba Niederhofer 2009 Hasanzadeh et al. 2012 Paliperidone Roser et al. 2009 Stigler et al. 2010

  41. Published Studies of Psychopharmacotherapy of ASD Other Medications for ASD Problematic Behaviors__ Levocarnitine Geier et al. 2011 Mecamylamine Arnold et al. 2012 Luteolin formulation (NeuroProtek) Theoharides et al. 2012 Taliou et al. 2013 Vitamin D Cannell 2013 Yokukansan (TJ-54) Wake et al. 2013

  42. Published Studies of Psychopharmacotherapy of ASD Since 1966, there are more than 92 different kinds of medications that have been tried with “publication” to treat ASD or ASD symptoms.

  43. How Strong is the Scientific Evidence of Effectiveness of these Medications ?

  44. Autism Society of America RESOLUTION ON PHARMACOLOGICAL ABUSE • WHEREAS, help becomes abuse when the balance of costs and benefits to the helper is greater than the balance to the person helped, and help in the form of psychoactive medication easily can become abuse; specifically, Medication is easy to administer; the strategy of using it to control problem behavior is simple to understand; and it often rapidly reduces that behavior; thus caregivers may prefer it when more beneficial interventions require from them more insight, effort, skill, patience, or tolerance; • Adopted by the Autism Society of America September 10, 1988

  45. North Carolina study (Aman et al.,1995) supports the growing concern that the increased reliance on medication therapy may represent a trend of replacing quality programming for persons with ASD by attempting to find a “quick fix” of emotional and behavioral problems through the use of medications.

  46. Are these psychotropic drugs APPROPRIATE for individuals with ASD?

  47. “Off‑labeled" or “Unlabeled" use of a Medication - 1 • A drug is "approved" by FDA for marketing if • its clinical database supports its benefit for a recognized condition, and • its risks are sufficiently offset by its efficacy for a particular indication. • The term "labeling" refers to the indications of a new medication that can be promoted by the pharmaceutical company.

  48. “Off‑labeled" or “Unlabeled" use of a Medication - 2 • When a new medication is marketed, a package is inserted for use by physicians. The insert contains basic pharmacological information, and essential clinical information regarding approved indications, contraindications, precautions, warnings, adverse reactions, usual dosage, and available preparations. • When a physician uses a medication for indications beyond those stated in the package insert, then an "approved“ medication is being prescribed for an "off‑labeled“ or "unlabeled" indication.

  49. Off-Label Prescribing Common • Almost all the psychotropic medications that have been prescribed to children in the United States are off-label use of the drugs. Arch Intern Med 2006;166:1021-1026.

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