Status:
COMPLETED
Preventive Measures for Childhood-Onset Obsessive-Compulsive Disorder and Tic Disorders (PANDAS Subgroup)
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Mental Disorder Diagnosed in Childhood
Obsessive Compulsive Disorder
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic disorders has been identified who share a common clinical course characterized by dramatic onset and symptom ...
Detailed Description
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 Neurop...
Eligibility 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
Key Trial Info
Start Date :
April 1 1993
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00001359
Start Date
April 1 1993
End Date
January 1 2006
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892