Trials
Search / Trial NCT00001359

Preventive Measures for Childhood-Onset Obsessive-Compulsive Disorder and Tic Disorders (PANDAS Subgroup)

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Trial Information

Current as of March 15, 2025

Completed

Keywords

Obsessive Compulsive Disorder Pandas Associated With Streptococcal Infections Adolescents Autoimmune Illness Children Tic Disorders Streptococcal Infections Childhood Onset Neuropsychiatric Disorder

ClinConnect 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. ...

Gender

ALL

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

About National Institute Of Mental Health (Nimh)

The National Institute of Mental Health (NIMH) is a leading federal agency dedicated to advancing the understanding and treatment of mental health disorders through innovative research and clinical trials. As part of the National Institutes of Health (NIH), NIMH focuses on a broad spectrum of mental health issues, including mood disorders, anxiety disorders, schizophrenia, and developmental disorders. By fostering collaboration among researchers, clinicians, and the community, NIMH aims to translate scientific discoveries into effective interventions and improve mental health outcomes for individuals across the lifespan. Through its commitment to rigorous research methodologies and ethical standards, NIMH plays a pivotal role in shaping the future of mental health care and policy.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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