6/20/2014. Medication in SMS: What s the evidence? What s reasonable? Management of Children with Developmental Disorders

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1 Medication in SMS: What s the evidence? What s reasonable? Tom Challman, MD Medical Director Autism & Developmental Medicine Institute Geisinger Health System Management of Children with Developmental Disorders Educational and behavioral interventions Preschool and school programs Specific strategies Intensive behavior therapy Structured teaching Speech and language therapy Occupational therapy Physical therapy Social skills instruction Management of Children with Developmental Disorders Medical management Medication for challenging behaviors Seizures Gastrointestinal problems Sleep disturbance 1

Effective medical treatment may allow a child to benefit

2 Medication Therapy May effectively alleviate or modify certain behavioral symptoms or co-existing disorders Effective medical treatment may allow a child to benefit more optimally from educational and behavioral interventions 2

3 Actually, only 2 of these were medication studies 3

4 Medication Therapy in SMS Pharmacological treatment of disruptive behavior in Smith-Magenis syndrome Laje G, Bernert R, Morse R, Pao M, Smith, ACM. American Journal of Medical Genetics. Part C, Seminars in Medical Genetics. 154C(4):463-8, 2010 Nov 15. Parents or other caregivers of 62 individuals with SMS were asked about use of psychotropic medication from a list of commonly used psychiatric medications Respondents were asked to rate the experience with the particular medication Medication Therapy in SMS Drugs were grouped into seven main categories: (1) stimulants; (2) antidepressants; (3) antipsychotics; (4) sleep aides; (5) mood stabilizers; (6) alpha 2 agonists; and (7) benzodiazepines Six of the seven medication categories examined showed no meaningful deviations from the "no change" score The benzodiazepine group showed a mild detrimental effect Use of psychotropic medication started early in life (mean age 5 years), particularly with sleep aids Sleep in SMS Sleep disturbance in Smith-Magenis syndrome Smith AC, Dykens E, Greenberg F. American Journal of Medical Genetics. 81(2):186-91, 1998 Mar individuals with SMS (1.6 to 32 years of age) 4

5 Sleep in SMS Sleep problems included difficulties falling asleep shortened sleep cycles frequent and prolonged nocturnal awakenings excessive daytime sleepiness, daytime napping snoring bed-wetting Medication to facilitate sleep was used by 59% of SMS subjects Sleep in SMS Sleep disturbance in SMS is attributed to a phase shift of the circadian rhythm of melatonin with a paradoxical daytime secretion of the hormone Nocturnal sleep disturbances Afternoon sedation These issues contribute to behavioral disturbances Sleep in SMS Melatonin Treatment in Smith Magenis Syndrome Wheeler B, Taylor B, Simonsen K, Reith DM. Sleep, Vol. 28, No. 12, 2005 Single patient design ( n-of-1 trial ) Treatment with melatonin shortened the time it took to fall asleep, but did not increase the duration of sleep, or improve the quality of sleep Did not improve behavior Did not improve quantity of parental sleep 5

6 Sleep in SMS 1-adrenergic antagonists and melatonin reset the clock and restore sleep in a circadian disorder, Smith-Magenis syndrome De Leersnyder H, et al. J Med Genet 2003;40: children with SMS Treated with acebutolol in the early morning, and slowrelease melatonin (6 mg) in the evening Restored a normal circadian rhythm of melatonin secretion Reduced night awakenings Increased hours of sleep Reduced disruptive behavior, improved concentration Beta 1-adrenergic antagonists and melatonin reset the clock and restore sleep in a circadian disorder, Smith-Magenis syndrome. De Leersnyder H; Bresson JL; de Blois MC; Souberbielle JC; Mogenet A; Delhotal-Landes B; Salefranque F; Munnich A Journal of Medical Genetics. 40(1):74-8, 2003 Jan. 2 Sleep Hygiene Sleep onset is disrupted by stimulating activities new or unexpected events anxiety excessive noise, cold or heat vigorous exercise hunger large meals pain certain medications 6

7 Sleep Hygiene Sleep onset is promoted by calming activities: well-structured bedtime routines quiet baths soft music small snacks the presence of small toys or a familiar blanket comfortable bed within a secure, quiet environment Medication Therapy: General Approaches Coexisting diagnosis Depression, anxiety disorders, OCD, bipolar disorder, ADHD, etc. Modified diagnostic criteria, unknown validity Target symptom approach Treat amenable target symptoms Neurobiology/genetics Theoretical Clinical trials in Fragile X, tuberous sclerosis, others Common Target Symptom Clusters Sleep problems ADHD symptoms hyperactivity, impulsivity, inattention, distractibility Irritability tantrums, aggression, self-injury Repetitive behavior, behavioral rigidity obsessions, compulsions, perseveration, ritualistic behavior, motor stereotypy, insistence on sameness 7

8 Evaluation of Target Symptoms Identify and assess target behaviors Parent/caregiver interview, input from school staff and other caregivers Frequency, Intensity, Duration Exacerbating factors/triggers Ameliorating factors and response to behavioral interventions Time trends (increasing, decreasing, stable) Degree of interference with functioning Evaluation of Target Symptoms Baseline behavior rating scales and/or baseline direct observational data Consider formal functional analysis of behavior Search for medical factors that may be causing or exacerbating target behaviors Consider sources of pain or discomfort Consider other medical causes or contributors (obstructive sleep apnea, seizures, menstrual cycle, etc.) Medical Conditions That May Cause Maladaptive Behaviors Allergies atopic dermatitis environmental (rhinitis, conjunctivitis) food Dental Discomfort abscess, decay eruption, impaction trauma Endocrine Disorders thyroid disorders premenstrual discomfort Gastrointestinal Disorders constipation diarrhea, cramping esophagitis, reflux Infectious Diseases ear, sinus, throat infections Medication Side Effects prescription medications over-the counter medications Musculoskeletal Problems strain or sprain fracture Neurological Disorders headache seizures Nutritional Deficiencies iron deficiency malnutrition zinc deficiency Ophthalmologic Problems corneal abrasion Sleep Disorders obstructive sleep apnea 8

9 Initiation of Medication Therapy Choose a medication on the basis of: Likely efficacy for the specific target symptoms Potential adverse effects Practical considerations, such as formulations available, dosing schedule, cost, and requirement for laboratory or EKG monitoring Patient s other medical conditions (e.g., obesity) that might be exacerbated by certain medications Informed consent from parent/guardian and, when possible, assent from the patient Initiation of Medication Therapy Establish a plan for monitoring of effects Identify outcome measures for the target behaviors/symptoms Discuss time course of expected effects and appropriate timing of follow-up telephone contact, completion of rating scales, reassessment of behavioral data, and office visits Obtain baseline laboratory data if necessary for the drug being prescribed and plan appropriate future lab monitoring Initiation of Medication Therapy Outline a plan regarding what might be tried next if there is a negative or suboptimal response or to address additional target symptoms Change to a different medication Add another medication to augment a partial or suboptimal therapeutic response to the initial medication (same target symptoms) Add a different medication to address additional target symptoms that remain problematic 9

10 Monitoring of Medication Therapy Explore the reasonable dose range for a single medication for an adequate length of time before changing to or adding a different medication Increase dose to optimal effect without intolerable side effects Monitor for adverse effects systematically Consider careful withdrawal of the medication after 6-12 months of therapy to determine whether it is still needed Medication Options for Common Target Symptoms Target Symptoms ADHD symptoms (hyperactivity, impulsivity, inattention, distractibility) Irritability, tantrums, aggression, self-injury Medication Methylphenidate Atomoxetine Clonidine Guanfacine Aripiprazole Olanzapine Risperidone Clonidine Guanfacine Fluvoxamine Valproate Medication Class Psychostimulants Selective Norepinephrine Reuptake Inhibitors Alpha-2 Agonists Atypical Antipsychotics Alpha-2 Agonists Selective Serotonin Reuptake Inhibitors Anticonvulsant Mood Stabilizers Medication Options for Common Target Symptoms Target Symptoms Medication Medication Class Repetitive behavior, behavioral rigidity, obsessive-compulsive symptoms Aripiprazole Olanzapine Risperidone Valproate Atypical Antipsychotics Anticonvulsants Fluoxetine Fluvoxamine Selective Serotonin Reuptake Inhibitors Sleep dysfunction Melatonin Endogenous chronobiotic hormone with hypnotic properties 10

11 Medication + Behavioral Intervention RUPP Autism Network (Aman et al., JAACAP 2009) 24 week study Medication (risperidone) with or without parent behavioral training Risperidone combined with parent behavioral training resulted in greater reduction of serious maladaptive behavior than risperidone alone It is a capital mistake to theorize before one has data. Insensibly one begins to twist facts to suit theories, instead of theories to suit facts. Sherlock Holmes, in Arthur Conan Doyle s A Scandal in Bohemia Non-standard Therapies Special diets Supplements Vitamins Detoxification strategies (chelation) Antifungal, antiviral medications Hyperbaric oxygen Vision therapy 11

12 Twelve questions that can help identify questionable therapies (adapted from Nickel, 1996, and Lilienfeld, Lynn, and Lohr, 2003): Questions related to the underlying theoretical basis for the therapy 1. Is the treatment based on a theory that is overly simplistic? 2. Is the treatment based on proposed forces or principles that are inconsistent with accumulated knowledge from other scientific disciplines? 3. Has the treatment changed little over a very long period of time? Questions related to the scientific evaluation of the therapy 4. Is it possible to test the treatment claim? 5. Have well-designed studies of the treatment been published in the peer-reviewed medical literature? 6. Do proponents of the treatment cherry pick data that supports the value of the treatment, while ignoring contradictory evidence? 12

13 Questions related to the scientific evaluation of the therapy 7. Do proponents of the treatment assume a treatment is effective until there is sufficient evidence to the contrary? 8. Do proponents claim that a particular treatment cannot be studied in isolation, but only in combination with a package of other interventions or practices? Questions related to the promotion and marketing of the therapy 9. Is the treatment promoted as being natural or free of adverse effects? 10. Is the treatment promoted primarily through the use of anecdotes? 11. Is scientific-sounding, but nonsensical, terminology used to promote the treatment? 12. Is the treatment promoted for widely diverse conditions? Uncritically accepting every proffered notion, idea, and hypothesis is tantamount to knowing nothing. Carl Sagan 13

14 My Thank you! 14

3/19/2018. Cynthia King, MD Associate Professor of Psychiatry UNMSOM. Autism Spectrum Disorder

3/19/2018. Cynthia King, MD Associate Professor of Psychiatry UNMSOM. Autism Spectrum Disorder Cynthia King, MD Associate Professor of Psychiatry UNMSOM Autism Spectrum Disorder 1 Identify three behavioral health concerns in ASD Identify three common families of medication that may be supportive