Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections
Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Dec 9, 2002
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
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 amoxici...
Gender
ALL
Eligibility criteria
- • Subjects with presence of OCD and/or tic disorder: Must meet lifetime diagnostic criteria (DSM III or DSM IV) for obsessive compulsive disorder or a tic disorder.
- • Pediatric onset: Symptoms of the disorder first become evident between 3 years of age and the beginning of puberty, as is generally true for rheumatic fever.
- • Episodic course of symptom severity: Clinical course is characterized by the abrupt onset of symptoms or by dramatic symptom exacerbations. Episodic course is characterized by waxing and waning or symptom severity with greater than +20 percent fluctuation from baseline.
- • Association with GABHS infection: Symptom onset or exacerbations must be temporally related to group A B-Hemolytic Streptococcal infections (GABHS), i.e., associated with positive throat culture and/or elevated anti-GABHS antibody titers.
- • Association with neurological abnormalities: During symptom exacerbations, patients will have an abnormal neurological examination, such as motoric hyperactivity and adventitious movements (i.e., choreiform movements or tics).
- • Subjects must report history of improvement in their tics and/or OCD when treated with amoxicillin.
- • No subjects who meet criteria for Autism.
- • No subjects who have neurologic disorders other than tics/TS.
- • No subjects who have and IQ less than 80.
- • No subjects who have a serious concurrent or chronic medical illness.
- • No subjects who have a history of penicillin or amoxicillin allergy.
- • No subjects with history of noncompliance with medical procedures.
About National Institute Of Mental Health (Nimh)
The National Institute of Mental Health (NIMH) is a leading federal agency dedicated to advancing the understanding and treatment of mental health disorders through innovative research and clinical trials. As part of the National Institutes of Health (NIH), NIMH focuses on a broad spectrum of mental health issues, including mood disorders, anxiety disorders, schizophrenia, and developmental disorders. By fostering collaboration among researchers, clinicians, and the community, NIMH aims to translate scientific discoveries into effective interventions and improve mental health outcomes for individuals across the lifespan. Through its commitment to rigorous research methodologies and ethical standards, NIMH plays a pivotal role in shaping the future of mental health care and policy.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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