A Trial of Prophylaxis for the PANDAS Subgroup
Penicillin or Placebo
Anxiety Disorders+10
+ Bacterial Infections and Mycoses
+ Bacterial Infections
Treatment Study
Summary
Study start date: April 1, 1993
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: Ages 4 - 18 years Fulfill criteria for membership in the PANDAS subgroup: Presence of OCD and/or tic disorder Prepubertal symptom onset Abrupt onset and episodic (relapsing-remitting) symptom course Association between symptom exacerbations and GABHS infections Presence of choreiform movements or other neurological abnormalities during symptom exacerbations. Because "time to relapse" is one of the primary outcome variables, children will not be eligible for randomization until their symptoms are in (at least partial) remission. At the time of randomization, symptom severity scores should be less than 50% of the child's previous maximum score on both the CY-BOCS and YGTSS, and no higher than a total score of 20 on the CY-BOCS or 30 on the YGTSS. EXCLUSION CRITERIA: Personal history of penicillin allergy History of rheumatic fever, including Sydenham's chorea Diagnosis of autism, schizophrenia or other psychotic disorder Chronic illnesses, particularly neurologic and immunologic disorders
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Mental Health (NIMH)
Bethesda, United StatesOpen National Institute of Mental Health (NIMH) in Google Maps