Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001658
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Placebo Controlled Trial of Amoxicillin for Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
Status:
COMPLETED
Status Verified Date:
2000-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor tic disorder in children As a result each time a child with one of these disorders experiences an infection with GABHS hisher 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
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 andor tic disorder in children As a result each time a child with one of these disorders experiences an infection with GABHS hisher 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
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 andor 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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-M-0145 | None | None | None |