Mental Disorder Clinical Trial
Official title:
A Placebo Controlled Trial of Amoxicillin for Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
Bacteria carry substances on their surface called antigens. When antigens come into contact
with the right kinds of cells in the body an immune reaction is caused. This reaction is
often the symptoms of sickness that a patient feels.
In order for the body to fight off the attack of antigens, it creates substances called
antibodies. Antibodies counter the action of antigens and make the bacteria harmless.
However, the immune system must learn how to make the right antibodies for the right
antigens. Sometimes the body creates antibodies that confuse normal tissues as foreign and
attack them. This is called an autoimmune reaction and sometimes occurs when the body is
exposed to certain bacteria.
One bacteria known for causing autoimmune reactions is Group A beta-hemolytic Streptococcus
(GABHS). This bacteria often causes throat infections commonly known as "strep throat". Some
researchers believe that the autoimmune reaction associated with strep throat infections may
cause neuropsychiatric disorders, like obsessive-compulsive disorder and/or tic disorder in
children. As a result, each time a child with one of these disorders experiences an
infection with GABHS his/her symptoms can reoccur or worsen. Researchers believe that by
giving patients a certain antibiotic, they can prevent GABHS infection and thus prevent the
return of symptoms.
This study is designed to test the effectiveness of the antibiotic Amoxicillin for the
treatment of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal
infections (PANDAS). Patients will receive Amoxicillin for six weeks and placebos "inactive
sugar pills" for six weeks in order to see if the medication is truly working. Effectiveness
of the treatment will be based on the presence or absence of symptoms. If at the end of the
study Amoxicillin is proven to be effective treatment for PANDAS patients may be offered the
opportunity to continue taking the medication for an additional six months.
An increasing body of evidence suggests that Group A beta-Hemolytic Streptococcal throat
infections (GABHS) may trigger the onset of obsessive-compulsive disorder (OCD) and/or tic
disorder in certain vulnerable children via an autoimmune process. In this subgroup of
children with childhood-onset OCD and tic disorders, preliminary data suggest some children
have a rapid response to amoxicillin. After only 24 to 48 hours of treatment, they have a
dramatic reduction in OC symptoms and tics. To date, we have observed this phenomenon in at
least 5 children, each of whom relapsed when the amoxicillin was stopped. These observations
raise a number of questions, including whether or not amoxicillin has a direct central
nervous system (CNS) effect or an indirect effect through perturbations of the immune system
(e.g., cytokine shifts).
The purpose of this study is to determine if amoxicillin is an effective treatment for
PANDAS, as well as examining possible mechanisms of this effect. We propose to do this with
a 3-month double-blind placebo-controlled crossover trial of amoxicillin treatment with a
randomized A-B-A-B design. Outcome measures will be blinded ratings of tic severity,
standardized measures of psychopathology, and immunologic assays (such as type I and type II
cytokine levels).
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