Autism Therapy: open-label study

definition of open-label study: Type of scientific study in which the scientist, doctor, and patient all know which drug or medication is being tested. This type of study is different from the double-blind study in which they don’t know whether they are taking a drug or placebo.

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Aripiprazole in Pervasive Developmental Disorder Not Otherwise Specified and Asperger’s Disorder: A 14-Week, Prospective, Open-Label Study
Journal of Child and Adolescent Psychopharmacology, by Stigler, KA, Diener JT, Kohn AE, Li L., Erickson CA, Posey DJ, and McDougle CJ, published in 2009, summarized Jul 22, 2010

Aripiprazole may help to improve severe irritability in children with pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger syndrome.

This prospective, open-label study sought to find out if the drug aripiprazole was safe and helpful as a treatment for irritability in children with PDD-NOS and Asperger syndrome. The 14-week study found that aripiprazole was safe and may be helpful for such patients. The patients showed decreased irritability as well as increased social behavior. The authors note that there are not many studies of patients with PDD-NOS (as opposed to autism). PDD-NOS is the most common subtype of PDD and the authors called for more studies of these patients.


Memantine as Adjunctive Therapy in Children Diagnosed with Autistic Spectrum Disorders: An Observation of Initial Clinical Response and Maintenance Tolerability
Journal of Child Neurology, by Chez, MG, Burton Q., Dowling T., Change M., Khanna P., and Kramer C., published in 2007, summarized Sep 6, 2007

The Alzheimer drug memantine may help with language, behavior and self-stimulating behavior in people with autism.

Some doctors believe that the immune system of children with autism acts on the brain to stop nerve cells from talking to each other. This open-label study was designed to see if memantine therapy can help people (aged 2-26) with autism by helping those nerve cells talk to each other. The study did not have placebo controls and therefore could not control for any bias from the parents or doctors who were reporting on the patients. The study lasted 21 months and found that patients did better when they were treated with memantine. Memantine was given as an add-on therapy to whatever other therapies the children were getting and it did not cause any serious side effects.


Oral Human Immunoglobulin for Children with Autism and Gastrointestinal Dysfunction: A Prospective, Open-Label Study
Journal of Autism and Developmental Disorders, by Schneider, CK, Melmed RD, Enriquez FJ, Barstow LE, Ranger-Moore J., and Ranger-Moore JA, published in 2006, summarized Mar 7, 2007

Treatment with oral immunoglobulin may improve gastrointestinal (GI) symptoms and behavior in children with autism.

About one quarter of children with autism have GI problems such as diarrhea or constipation. The twelve children in the study were fed nightly doses of 420 mg of immunoglobulin for eight weeks. Earlier studies have shown that about 50% of immunoglobulin that is eaten is biologically active in the gut. The study measured effect of immunoglobulin therapy on stool number, stool texture, and stomach tenderness. Oral immunoglobulin appeared to be safe treatment option for autism.


A Prospective, Open-Label Trial of Memantine in the Treatment of Cognitive, Behavioral, and Memory Dysfunction in Pervasive Developmental Disorders
Journal of Child and Adolescent Psychopharmacology, by Owley, T., Salt J., Guter S., Grieve A., Walton L., Ayuyao N., Leventhal BL, and Cook EH, published in 2006, summarized Jan 24, 2007

Memantine (0.4 mg/kg) may help the memory and behavior of children with autism.

Memantine is used for the treatment of Alzheimer'??s disease. This was an open-label study, which means that the doctors, the parents, and the children all knew that the children were being given the drug. While parents thought that the drug helped all of the symptoms of autism (Clinical Global Improvement), the doctors did not notice a difference. The authors suggest that the better memory seen with the drug could have come from changing the brain chemistry or could have come from helping the child to pay attention. The authors note that it is difficult to know what dose of the drug to give children.


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