- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001658
Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Mental Health (NIMH)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neurologic Manifestations
- Disease Attributes
- Movement Disorders
- Personality Disorders
- Anxiety Disorders
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Dyskinesias
- Neurodevelopmental Disorders
- Disease
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Infections
- Communicable Diseases
- Mental Disorders
- Autoimmune Diseases
- Tic Disorders
- Tics
- Streptococcal Infections
- Anti-Infective Agents
- Anti-Bacterial Agents
- Amoxicillin
Other Study ID Numbers
- 970145
- 97-M-0145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive Compulsive Disorder
-
Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
-
Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
-
NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
-
Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
-
Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
-
Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
-
Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
-
Roseli ShavittCompleted
-
University of South FloridaMassachusetts General HospitalCompletedObsessive-compulsive DisorderUnited States
Clinical Trials on Amoxicillin
-
Saskatchewan Health Authority - Regina AreaNot yet recruiting
-
University of Alabama at BirminghamMerck Sharp & Dohme LLCCompletedPostpartum Sepsis | Postpartum Endometritis | Postpartum FeverCameroon
-
University Medical Centre LjubljanaUniversity of Ljubljana School of Medicine, SloveniaRecruiting
-
Malmö UniversityCompletedAntibiotic Prophylaxis | Infection ControlSweden
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityCompletedHelicobacter Pylori Eradication RateChina
-
Assistance Publique - Hôpitaux de ParisCompletedChronic Obstructive Lung Disease (COLD)France
-
Ranbaxy Laboratories LimitedCompletedHealthyUnited States
-
University Hospital, Clermont-FerrandUnknown
-
Klara Posfay-BarbeGertrude Von Meissner Foundation; Recherche et Développement des HUG; Société...UnknownGroup A Streptococcal PharyngitisSwitzerland
-
Il-Yang Pharm. Co., Ltd.CompletedHelicobacter InfectionsKorea, Republic of