Medicating Autism: A Research Paper

Here is a paper that I wrote for my research paper in my community psychology class relating to autism.  It is on medications and autism.  There are probably grammatical errors or parts that don’t quite make sense, but I just wanted to publish it after I wrote it (I’ll probably update it with a revised version, but read it if you would like).


MEDICATING AUTISM

Introduction

In 1995, two governmental groups (the National Institute of Mental Health and the U.S. Food and Drug Administration) cosponsored a conference that brought researchers, patient advocates, and mental health professionals together.  After the conference, a request was sent out to ask for more research studies on the psychotropic drugs that were being prescribed to children with autism between the ages of zero and seventeen.

Prior to this, doctors were prescribing drugs that had been tested and determined effective for adults to children with autism.  However, nothing was known of the effects these had on children.  This request is now known as the Research Units on Pediatric Psychopharmacology, or RUPPs (“Risperidone is effective for one of three core symptoms of autism”).

In the years that followed, many studies were done testing out new drugs and old to determine their effect on children with autism.  The immediate research question that comes up from this research question is “How many children with autism are prescribed medication to treat their autistic symptoms?”

Prevalence of Medication in Children with Autism

In 2014, Jane Schubart, Fabian Camacho, and Douglas Leslie studied this exact question.  They gained access to “Medicaid Analytic eXtract (MAX) data from 41 states for 2000-2003…[which] provide person-level data and include information on Medicaid eligibility, service utilization, and payments” (p. 632).  The data set they studied was nearly 3 million children and adolescents.  They broke psychotropic drugs into six categories: antidepressants, neuroleptics, anxiolytics, mood stabilizers, sedative/hypnotics, and stimulants

The ASD population they looked at was “13,390 in 2000…15,805 in 2001; 16,818 in 2002; and 19,243 in 2003” (p. 632).  For the comparison group, they looked at non-ASD population they looked at was individuals who were diagnosed with certain types of mental health disorders.  They do not give the number they looked at for the comparison group.

They found that about 65% of children with ASD receive psychotropic medication with antipsychotics being the most common (39%).  30% of these children were prescribed psychotropic medications in more than one class.  The control group had a smaller percentage (54.3%-57%) of patients receiving psychotropic medication.  An average of 36.9% of children with ASD were on psychotropic drugs compared to 13.7% in the control group.

Some interesting aspects that were found were children who were classified as “poverty or foster care had more treatment days. By ethnicity/race, White children had more treatment days than African American or Latino children” (p. 635).  They discuss one thing that could be further researched:

Although little is known about  the  long-term  safety  and  efficacy  of  psychotropic medication use and polypharmacy in children and adolescents, long-term use of these medications may have clinical benefits that outweigh the risk of side effects (e.g. stimulants  in  children  with  ASDs  who  have  attention  deficit hyperactivity  disorder  (ADHD)  symptoms).  Further research is needed to evaluate these trade-offs. (p. 636)

One limitation that they brought up were the data set that they used was “designed for billing purposes and do not contain detailed clinical information such as measures of symptoms or severity and other variables that might be related to medication use, and may not be generalizable to non-Medicaid populations” (p. 636).

If 65% of children with autism are receiving psychotropic medications, what studies have been done to determine the efficacy of these medications in children with autism?

Antipsychotics: Risperidone

Risperidone was approved by the Food and Drug Administration (FDA) for treatment in 2006.  It was the “first drug to treat irritability associated with autism” (“FDA Approves”).  According to McDougle et al. (2005), they found that risperidone makes a significant improvement on the behavioral disturbances of autism (defined as severe tantrums, aggression, and self-injurious behavior).

However, the study cited here looks at the same study, but from a different viewpoint.  Rather than determining if there are significant improvements on behavioral disturbances, the authors set out to determine if risperidone has any effect on autism’s core symptoms.

They did this by conducted an 8-week double blind, placebo-controlled trial of risperidone.  During this time, they modified and administered 3 times (baseline, week 4, and week 8) several rating scales that related to the core symptoms of autism: the Ritvo-Freeman Real Life Rating Scale, the compulsion scale of the Children’s Yale-Brown Obsessive Compulsive Scale, and the Maladaptive Behavior Domain of Vineland Adaptive Behavior Scales.

They found that, compared with the placebo, risperidone significantly reduced the overall score on “subscales [on the Ritvo-Freeman Real Life Rating Scale] for sensory motor behaviors (subscale I), affectual reactions (subscale III), and sensory responses (subscale IV)” (p. 1144).  However, risperidone did not have a statistically significant effect on social relatedness or language.  The Children’s Yale yielded similar results on the repetitive behaviors, which “went from 15.51…to 11.65” (p. 1145).  This is compared to the placebo group, which went from 15.18 to 14.21.

The conclusion they came to was:

The results of this analysis of secondary measures indicate that 8 weeks of treatment with risperidone is not significantly different from placebo for the qualitative impairment in social interaction and communication that characterize autism, but repetitive and stereotyped patterns of behavior, interests, and activities did improve. (p. 1147)

One limitation they point out was their use of modified scales that have not been empirically studied for reliability and validity.  They point out, however, that “there are no currently available instruments designed to measure change in these particular target symptom domains” (p. 1147).

Another limitation that is not explicitly stated in the article is the use of scales rather than direct observations.  Scales are liable to more subjectivity and don’t allow for as much information to determine the efficacy of a medication.

This study shows that while Risperidone is FDA approved to treat irritability, it can also possibly have an effect on repetitive behaviors, a core symptom of autism.  At one point, however, they point out that patients with OCD who take medication are usually also doing therapy as well.  This next study points out what happens when antipsychotics (mainly Risperidone) is used in tandem with Parent Training.

Medication + Therapy

A study was published in 2009 by Aman et al. that set out to determine if there was a statistically significant decrease in problem behaviors (temper tantrums, irritability, self-injurious behavior, etc.) when comparing medication alone with parent training of behavior management and medication.  There was no placebo in this study, but there was a control group. The control group were those who just received the medication.  Whether the child were in the intervention or control group, if they did not respond to the risperidone, the researchers switched them to aripiprazole.

They gave multiple assessments that were modified including: the Autism Diagnostic Interview-Revised, Home Situations Questionnaire (HSQ), Vineland Adaptive Behavior Scales, Clinical Global Impressions (both Severity and Improvement subtests), Aberrant Behavior Checklist, and Children’s Yale-Brown Obsessive-Compulsive Scale-PDD Version.

The parent training group “consisted of 11 core treatment sessions, three optional, and up to three booster (two via telephone, one in person) sessions (maximum of 17 sessions), each 60-90 minutes” (p. 1145).

They found that scores on the HSQ declined 71% from 4.31 to 1.23 for the children who received both compared to a decline of 60% (4.16 to 1.36) for the control group.

An interesting thing to note is that their weight increased from the baseline to the last observed visit.  For the medication alone, the population went from 69.27 to 81.15. For the combined, the population went from 67.55 to 80.98.

There were many adverse effects that were listed during this trial.  Approximately 80% of both groups developed rhinitis from the medication.  Symptoms of this are similar to hay fever (allergies).

They came to the conclusion that Combined treatment of parent training and medication reduces behavior problems.

One of the potential limitations they bring up is that the Combined group automatically had more contact with therapists as compared to the medication only group.  This contact may have been responsible for the differences between the groups.

Risperidone is not the only drug that has been evaluated for its efficacy in treating behaviors associated with autism, however.  In the next two sections, studies evaluating the efficacy of Memantine and Oxytocin will be discussed.

Memantine

In their 2006 study, Erickson et al. conducted an experiment to look at the efficacy of memantine on the core social impairment of autism.  They point out that “some investigators have hypothesized that glutamatergic dysfunction may be important in the pathophysiology of autism…Glutamate is the primary excitatory neurotransmitter in the brain and plays a critical role in cortical functions, as well as neuronal development” (p. 142).  They used rating scales to determine the efficacy of memantine in the area of social impairment.

The population they studied was 13 patients diagnosed with autistic disorder, 3 with aspergers, and 2 with PDD-NOS for a total of 18 patients.  11 of these had a comorbid developmental delay.  13 of these 18 patients were receiving other medications during the memantine trial.

11 (or 61%) of the 18 patients were deemed responders as determined by receiving a 1 or 2 on the improvement rating scale.  Using the Aberrant Behavior Checklist that was available for 6 of the 18 patients, they were able to determine a significant improvement on the hyperactivity subscale from 23.17 at baseline to 16.33.

The adverse effects affected 7 of the 18 patients.  They included “increased irritability (n=4), rash (n=1), emesis (n=1), increased seizure frequency (n=1) and excessive sedation (n=1)” (p. 145).  Emesis is the action or process vomiting.

The conclusion they came to was “some patients showed clinically significant improvement in social interaction and attention” (p. 146).  However, one of the main limitations of this study is that it was a retrospective study.  Therefore, it was possible that it had observational and assessment bias.

Oxytocin

In 2003, Hollander et al. conducted an experiment on the drug oxytocin’s efficacy on treating repetitive behaviors.  Oxytocin is a naturally occurring hormone that is has been long known to play a role in milk ejection and uterine contraction during labor.  However, recent theories and subsequent research suggest that it also plays a role in developing normal cognition.

Their hypothesis for the study was that “infusion of synthetic oxytocin might modulate the severity of this repetitive behavior domain in patients with autism spectrum disorders” (p. 194).  They had 15 adult patients, 14 male and 1 female.  6 of them were diagnosed with  autism and 9 with asperger’s syndrome.  They determined that the control group would be individualized.  Therefore, every random time they came in for an infusion, they were put on a placebo.  By doing this, they found that they could compare each individual to themselves because people with autism are such a heterogeneous group.  Every two weeks, they received an intravenous infusion of oxytocin over a four hour period.

They observed for repetitive behaviors during these four hours and found that 13 of the 15 patients (86.7%), when infused with oxytocin, showed a decrease in repetitive behaviors whereas it was only 6 patients (40%) when they were infused with a placebo.  For 1 patient who received the oxytocin, their repetitive behaviors increase and it didn’t do anything for the last patient.  For 6 patients who received the placebo, repetitive behaviors increased and two were unchanged.

The adverse effects noted in the research were listed as mild and included “drowsiness, anxiety, depression, headaches, tingling, backaches, trembling, restlessness, stomach cramps and enuresis” (p. 196).

They came to the conclusion that “administration of exogenous oxytocin decreased the core autistic repetitive behaviors measured” (p. 196).  One limitation they point out is that this study was done with adults and it must be researched with children before it can be deemed effective in children.

Conclusion

These are just some of the studies that are part of what is called the Research Units on Pediatric Psychopharmacology, a request put out after the NIMH and FDA asking for research on the medications doctors were prescribing children with autism.

Based on this research, there are two possible future research opportunities.  The first includes looking at ABA alone compared with medication alone compared with ABA and medication.  This will allow insight into seeing which of these three are most effective over a period of a few months.

The second includes comparing trials where children are receiving one of three options: memantine, oxytocin, and both.  The behaviors that would be looked at are repetitive behaviors, inattention and social withdrawal.  This would allow researchers to determine if when taken together, these medications maintain the effects they have when they are alone when working with each other.

The studies discussed previously have shown that some of the symptoms of autism can be treated, depending on the child.  Risperidone and oxytocin can both possibly treat repetitive behaviors.  Memantine could possibly treat social withdrawal and inattention.  However, should they be used?

There are some opinions that say that autism is a way of being in the world.  If looked at in this way, it could be looked at as a subculture much like African American subculture. To use the African American subculture as an analogy, what if we were to pathologize their behaviors and say that they are wrong because they are not the norm (which is that of acting “white”)?  Their way of interacting with others, their way of using language, their way of behaving, and their way of being shows a deficiency because they are “incapable of being normal.”

Take this one step further, what if one of their only ways of communication is deemed “not normal,” “deviant,” or “problematic.”  Due to this perspective, those who are “normal” decide to medicate in order to get rid of this communication.  This communication for children and people with autism are tantrums, irritability, stereotypic behavior.  If we medicate one of their only ways of communicating with the world because it is “not normal,” “deviant,” or “problematic,” what are we really doing?  So, the question comes up again: should we medicate them?


References

Aman, M.G., Scahill, L., Arnold, L.E., Bearss, K., Nikolov, R., … Yu, S. (2009).  Journal of American Academy of Child and Adolescent Psychiatry, 48(12), 1143-1154.

Erickson, C.A., Posey, D.J., Stigler, K.A., Mullett, J., Katschke, A.R., & McDougle, C.J. A retrospective study of memantine in children and adolescents with pervasive developmental disorders. (2007). Psychopharmacology, 191, 141-147.

Food and Drug Administration. (2006). FDA approves the first drug to treat irritability associated with autism, risperdal. [Press release]. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108759.htm

Hollander, E., Novotny, S., Hanratty, M., Yaffe, R., DeCaria, C.M., Aronowitz, B.R., & Mosovich, S. (2003). Oxytocin infusion reduces repetitive behaviors in adults with autistic and asperger’s disorders. Neuropsychopharmacology, 28, 193-198.

McDougle, C.J., Scahill, M.G., Aman, M.G., McCracken, J.T., Tierney, E., Davies, M., … Vitiello, B. (2005). Risperidone for the core symptom domains of autism: Results from the study by the autism network of the research units on pediatric psychopharmacology. American Journal of Psychiatry, 162, 1142-1148.

Risperidone is effective for one of three core symptoms of autism. (2005). Brown University Child & Adolescent Psychopharmacology Update, 7(8), 1-7.

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