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:

  1. Ages 4 - 18 years

  2. Fulfill criteria for membership in the PANDAS subgroup:

    1. Presence of OCD and/or tic disorder
    2. Prepubertal symptom onset
    3. Abrupt onset and episodic (relapsing-remitting) symptom course
    4. Association between symptom exacerbations and GABHS infections
    5. 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:

  1. Personal history of penicillin allergy
  2. History of rheumatic fever, including Sydenham's chorea
  3. Diagnosis of autism, schizophrenia or other psychotic disorder
  4. 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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Page 1 of 1 (1 locations)

1

National Institute of Mental Health (NIMH)

Bethesda, Maryland, United States, 20892