Autism Therapy: double-blind

definition of double-blind: Non-biased method of testing the possible effects of a treatment. In a double-blind test, the people who are rating its effectiveness do not know whether the person they are rating has actually received the treatment or placebo. The person they are rating (who took the possible treatment) also does not know.

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A Placebo-Controlled, Fixed-Dose Study of Aripiprazole in Children and Adolescents with Irritability Associated with Autistic Disorder
J Am Acad Child Adolesc Psychiatry, by Marcus, RN, Owen R., Kamen L., Manos G., McQuade RD, Carson WH, and Aman MG, published in 2009, summarized May 13, 2010

Aripiprazole may help to treat irritability in children with autism.

This double-blind, placebo-controlled study compared the atypical antipsychotic aripiprazole with placebo in terms of being able to reduce irritability in children (aged 6 to 17 years) with autism. This eight week study found that aripiprazole was able to reduce irritability in children with autism. Children who received aripiprazole also had decreased hyperactivity. There was a high placebo response rate of 35% on this study. The authors also note that this was a fixed-dose study and therefore doctors were not able to change the dose of the drug based upon the patient’s response to the drug.


Secretin Is an Ineffective Treatment for Pervasive Developmental Disabilities: A Review of 15 Double-Blind Randomized Controlled Trials
Research in Developmental Disabilities, by Sturmey, P., published in 2005, summarized Oct 13, 2009

Secretin therapy may result in short term improvement of language and social problems in children with autism.

Secretin is a hormone produced by the gastrointestinal tract that helps the body to digest food. Secretin has been proposed as a therapy to treat autism This review article includes 15 studies of secretin therapy for children with autism. All 15 studies were double-blind, randomized, and placebo-controlled. None of the studies showed that secretin therapy could help children with autism. Some of the studies showed that language and social skills did get better, but the improvements did not last long. Four studies said that secretin may help children with autism who also have gut problems, but the data in these studies were not strong.


Placebo Effects in Developmental Disabilities: Implications for Research and Practice
Mental Retardation and Developmental Disabilities Research Reviews, by Sandler, A., published in 2005, summarized Sep 18, 2009

Placebo (sugar pill) effects seen in some studies of autism drug therapy need to be explored more, and may be helpful for autism therapy.

In placebo-controlled studies, patients on drug therapy are compared to patients taking a placebo. Often the patient and the researcher do not know who gets the placebo (double-blind). Usually researchers expect that the placebo will be a control, and will have no effect. But placebo groups have shown improvements in several studies of brain disorders in children. Secretin studies are a good example. From early studies, researchers thought that secretin may have been helpful for people with autism. But later, 10 placebo-controlled studies showed that secretin was no better than placebo. In those studies, the groups given placebo showed improvements as well. Researchers are trying to understand why some people taking placebo show improvements. They hope to understand this so that they can find ways to help people use less medication.


Double-Blind, Placebo-Controlled Study of Amantadine Hydrochloride in the Treatment of Children with Autistic Disorder
Journal of the American Academy of Child and Adolescent Psychiatry, by King, BH, Wright DM, Handen BL, and Sickich L., published in 2001, summarized Sep 16, 2009

Amantadine may improve behaviors in some children with autism.

This article reported results of a double-blind, placebo-controlled study of amantadine (drug that acts on the brain). There were 39 children (5-19 years old) in the study. Children received either amantadine (2.5 mg/kg for one week, and then 5.0 mg/kg for 3 weeks) or placebo (sugar pill). The researchers measured the children's behaviors using one standard test and the parents measured behaviors using a different standard test. The researchers found that treatment with amantadine decreased hyperactivity and inappropriate speech. The parents in both the placebo group and the amantadine group found improvements in behaviors. It was about the same degree of improvements in both groups. In other words, there was a noticeable "placebo effect" because parents reported improvements for 37% of children on placebo. In comparison, parents reported improvements for 47% of the children taking amantadine. The difference between the two groups with parent-measured tests was not large enough to be important. The authors talked about placebo effects reported in other studies of drug therapy for autism.


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Citalopram: No Effect in Autism

Dec 3, 2009 by Anonymous

Does citalopram help children with autism? A Citalopram (Cilexa®) study made a big splash in the autism community this month. Citalopram is an antidepressant that has been prescribed off-label for children with autism. Doctors thought it might reduce repetitive behaviors (rocking, hand flapping, etc.) in children with autism. A new study suggests that it probably won’t make a difference.  

Citalopram is a selective serotonin reuptake inhibitor (SSRI) which is a class of drugs that are FDA-approved for depression. SSRIs are said to be widely prescribed off-label for children with autism, but hard numbers are not known because of the off-label use. They are prescribed off-label for other conditions, including obsessive compulsive disorder (OCD) in children.  

King et al (2009) reported results of a large randomized, placebo-controlled, double-blind study of citalopram with 149 children (5-17 years old). The children had autism, Asperger syndrome, or pervasive developmental disorder not otherwise specified (PDD-NOS). All of the children had moderate to severe compulsive or repetitive behaviors. They received citalopram therapy (10-20 mg/day) or placebo for 12 weeks. 

Citalopram therapy did not reduce repetitive behaviors or improve any other behaviors that they measured more than placebo. The authors tested more than 11 behaviors and skills using 3 different standard clinical tests.  

Why is this important? For one thing, citalopram may be commonly prescribed for children with autism, though it is tough to know just how often. Pair that tidbit with the solid design study. The design is quite solid for this kind of study. They had 149 children in the study, placebo controls, double-blinded design, 12 weeks of drug therapy, and 3 standardized tests for 11 different behaviors. And they found no effect.  

The second reason it is important is that this study also showed a noticeable “placebo effect.” The placebo effect is when people who take placebo in the study report having a response (either better or worse). In this study, 34% of children taking placebo showed improvement in the behavioral test scores. The patients and the researchers didn’t know which they were receiving (hence the term “double-blind”). So about 1/3 of the patients showed improvements, whether they took the placebo or the drug. 


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