The Important Questions to Ask Before Considering Medications Michael J. Murray, M.D. Penn State...
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![Page 1: The Important Questions to Ask Before Considering Medications Michael J. Murray, M.D. Penn State College of Medicine Milton S. Hershey Medical Center.](https://reader038.fdocuments.in/reader038/viewer/2022110401/56649de75503460f94ae03cb/html5/thumbnails/1.jpg)
The Important Questions to Ask Before Considering Medications
Michael J. Murray, M.D.Penn State College of Medicine
Milton S. Hershey Medical Center
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Today’s Goals
• Questions to consider when thinking about adding medication to the treatment plan
• Guidelines for interpreting the research on medication
• A basic understanding of commonly used medications for ASD
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Beyond the Diagnosis
• Medication Management• Diagnosis of Comorbidities• Periodic Reassessment• Consultation with Other Treatment Providers• Therapy for the Individual• Therapy for the Family• Advocating for Best Practices
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“Typical” Treatment team may include…
• Primary Care Physician• Neurologist• Psychiatrist• Special Education
Teacher• Behavior Analyst• Speech Therapist• Physical Therapist
• Occupational Therapist• Behavior Specialist• Therapeutic Staff Support• Personal Care Aides• Recreational Therapist• Parents, Self-Advocates
and Other Family Members
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Things to Consider
• What are the potential risks?• How will potential adverse outcomes affect the
individual and the family?• Has the treatment been validated scientifically?• Are the assessment methods specified?
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Things to Consider
• How will the treatment be integrated into the individual’s other treatment interventions?
• Do not overvalue a given treatment such that functional curriculum, vocational life, and social skills are ignored.
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Things to Consider
• Most importantly, need to gauge the social validity of the proposed intervention with the individual and family as appropriate
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Social Validity
• Essentially asks, “How valuable is this?”
• Needs to be assessed before and intermittently throughout the intervention
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Interpreting Research Results
• Not all research is created equal• The design of the study significantly contributes to
the strength of the research findings or observations
• The stronger the research design, the more reliable the outcome
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Case Report
• A detailed report of the diagnosis, treatment, and follow-up of an individual patient.
• Also referred to as anecdotal report• Of limited benefit aside from justifying pilot studies
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Case Series
• A group or series of case reports involving patients who were given similar treatment. Reports of case series usually contain detailed information on diagnosis, treatment, response to treatment, and follow-up after treatment.
• Not hypothesis driven or controlled
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Open Label Study
• A type of study in which both the health providers and the patients are aware of the drug or treatment being given.
• Used frequently as they are easier to conduct than randomized studies and avoid ethical issues of withholding treatment.
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Randomized controlled trials
• The randomized, double-blinded, controlled clinical trial is the gold standard of study design
• This design provides protection from allocation bias by the investigator and from bias in assessment of outcomes by both the investigator and the patient.
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Non-Randomized Clinical Trials
• This category includes trials in which treatment allocation was made by a strategy that would make the allocation known to the investigator before informed consent is obtained from the patient.
• An imbalance can occur in treatment allocation under such circumstances.
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Other things to consider…
• The larger the “N” the better• The more variables matched the better• The longer the treatment phase the better• The longer the follow-up the better• The more assessment measures the better• The smaller the “p” the better
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Medication
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There Is No Magic Bullet
• Only one medication (risperidone) has been approved by the FDA as a treatment for autism spectrum disorders (ASD).
• However many medications can be helpful in alleviating some of the features of ASD.
• Medications can also treat the co-morbid disorders that often accompany ASD.
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Know What You’re Treating
• Have realistic and clear expectations for the trial.• Helpful to have data to support (or refute) a medication’s
efficacy.• Good communication is essential to ensure the child’s
optimal health and to increase the chance for success with potential trials.
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If considering a trial…
• Agree on a behavioral target, which is easily operationalized in multiple environments, and method of collecting data
• Establish a baseline of the behavior and perform other assessment measures if indicated
• Helpful to have positive and negative targets, if possible
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While undergoing the trial…
• Continue collecting data at agreed upon intervals and frequency
• Coordinate potential dose adjustments with other treatment interventions
• Give medication doses adequate time to demonstrate change (trends in behavior may take time to manifest)
• Helpful to graph data
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This assumes good communication with the treatment team, which can be a challenge in the “real world”.
However, some objective measure is necessary to determine medication efficacy and treatment outcome.
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Guiding Principles for ALL Trials.
Start Low (REALLY LOW). Go Slow (REALLY SLOW).
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Neurochemical Basis of Autism
• Literature primarily focused on two neurotransmitter systems:– Dopamine– Serotonin
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dopamine
• Atypical neuroleptics are the medications of choice to address dopamine dysregulation– Risperidone (Risperdal)*– Olanzapine (Zyprexa)– Quetiapine (Seroquel)– Aripiprazole (Abilify)
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Atypical Neuroleptic Targets
• Self-injury• Severe agitation• Stereotyped movements• Severe behavior problems
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RUPP Study
• Research Units in Pediatric Psychopharmacology Autism Network
• Large multi-site trial of the short-term and long-term safety and efficacy of risperidone in a group of over 100 children and adolescents with autism
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RUPP Study
• Phase I– 8 week double blind trial of placebo vs. risperidone– 70% of those receiving medication rated as much or
very much improved (12% on placebo)• Phase II
– 4 month open label extension of the study– Benefits sustained at stable dose
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RUPP Study
• Phase III– Subjects randomly assigned to continue active substance or to
gradual withdrawal with placebo– Relapse rate significantly higher in placebo group (although not
100%)• Most common side effects
– Weight gain– Sedation– Drooling
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serotonin
• Increase in blood serotonin• Brain serotonin synthesis seems to be disrupted• Post-pubertal children with autism have lower
serotonin concentrations than pre-pubertal children with autism (opposite the typical pattern)
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serotonin
• Selective Serotonin Reuptake Inhibitors (SSRI’s) are the medications of choice to address serotonin dysregulation– Fluoxetine (Prozac)– Fluvoxamine (Luvox)– Sertraline (Zoloft)– Citalopram (Celexa)– Escitalopram (Lexapro)
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SSRI Targets
• Repetitive behaviors• Stereotyped mannerisms• Difficulty with change or transition• Anticipatory anxiety• Obsessive compulsive behaviors• Depression
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The research
• Only small open label studies to date• A RUPP type study is underway for fluoxetine• Widely used clinically• Most common side effects
– Disinhibition– Irritability– Sleep disturbance
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Other Clinical Concerns
• ADHD-like behaviors– Stimulants can be helpful– Growing clinical use of atomoxetine (Strattera)
• Mood Instability– Anticonvulsants can be helpful– Be cautious with lithium
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Sleep Issues
• Children with autism have greater difficulty falling asleep and more frequent awakenings to full arousal during the night
• Can have significant impact on the child’s ability to participate in programming
• Quality of life issue for the family
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Sleep Issues
• If using medication for another indication, may try to exploit the sedating side effect of a particular agent
• Importance of good sleep hygiene is particularly important for this population
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Trends in Medication Usage
• In 1995, a survey found that 30.5% of the population sample were prescribed a psychotropic medication
• In 1999, a survey of high functioning individuals with autism found 55% taking at least one psychotropic medication
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Trends in Medication Usage
• A survey completed in 2006 found a prevalence of 70.2% among individuals with moderate autism
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Factors Associated with Higher Usage Rates
• Greater age
• More severe autism
• More severe intellectual limitations
• Housing outside of the family home
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Most Commonly Prescribed
• Antidepressants
• Antipsychotics
• Stimulants
• Antihypertensives
• Antiseizure medications
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References
Volkmar, F et al. Autism and pervasive developmental disorders, Journal of Child Psychology and Psychiatry, 45:1 (2004), pp135-70.
• American Academy of Child and Adolescent Psychiatry, Practice Parameters for the Assessment and Treatment of Children, Adolescents, and Adults with Autism and Other Pervasive Developmental Disorders, available at www.aacap.org.