Protocol Number: 93-M-0122

Title:

A Trial of Prophylaxis for the PANDAS Subgroup

Number:

93-M-0122

Summary:

The purpose of this study is to determine whether penicillin prevents the symptoms of Obsessive-compulsive Disorder (OCD) and tic disorders from recurring in children with

Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcus (PANDAS).

A subgroup of children with childhood-onset OCD and/or tic disorders share a common clinical course characterized by dramatic onset and symptom exacerbations following scarlet fever or strep. throat infections. Such infections may be prevented by the prophylactic (preventative dose) administration of antibiotics, such as penicillin. This study will determine the effectiveness of penicillin prophylaxis in preventing relapses of OCD and/or tics in the PANDAS subgroup.

Participants receive a comprehensive psychiatric, neurological and physical evaluation. Children will initially receive penicillin tablets, and then will be randomly assigned to receive either penicillin or placebo tablets for 6 months. Children will be monitored monthly by either in-person visits or a telephone interview. Any child who has a significant increase in his or her OCD or tics is taken off the randomized medication and put on open-label penicillin for the rest of the study.

For more information about this study please visit the Official P.A.N.D.A.S. Web Page at the following web address:

http://intramural.nimh.nih.gov/research/pdn/web.htm:

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients must meet criteria for the PANDAS subgroup, including:

1. A tic disorder and/or obsessive compulsive disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders-IV edition.

2. A history of a sudden onset of symptoms or an episodic course with abrupt symptom exacerbations interspersed with periods of partial or complete remission.

3. Onset of neuropsychiatric symptoms prior to puberty.

4. Evidence of an association between streptococcal infections and the onset of exacerbations of symptoms.

EXCLUSION CRITERIA:

History of rheumatic fever, including rheumatic heart disease and Sydenham's chorea.

History of other central nervous system autoimmune disorders such as Lupus (SLE), multiple sclerosis, Devek disease (optic neuritis), and Behcet disease (oculourethral syndrome).

History of autism.

History of neurologic disorders other than tics and Tourette Syndrome.

History of personal or family allergy to penicillin, erythromycin, clarithromycin, or azithromycin; current treatment with pimozide.

Special Instructions: Currently Not Provided

Keywords:

Obsessive Compulsive Disorder

PANDAS Associated with Streptococcal Infections

Adolescents

Autoimmune Illness

Children

Tic Disorders

Streptococcal Infections

Recruitment Keywords:

Childhood Onset Neuropsychiatric Disorder

Conditions:

Chorea

Mental Disorder Diagnosed in Childhood

Obsessive Compulsive Disorder

Streptococcal Infection

Tic Disorder

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Lorraine Lougee, L.C.S.W.
National Institutes of Health
Building 10
Room 3C101
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-5323
Fax: (301) 402-8497

Electronic Address: LougeeL@intra.nimh.nih.gov

Citations:

A pilot study of penicillin prophylaxis for neuropsychiatric exacerbations triggered by streptococcal infections

PANDAS: the search for environmental triggers of pediatric neuropsychiatric disorders Lessons from rheumatic fever

Pediatric autoimmune neuropsyhiatric disorders associated with streptococcal infections: Clinical description of the first 50 cases

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/20/2004