Completed

A Trial of Prophylaxis for the PANDAS Subgroup

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What is being tested

Penicillin or Placebo

Drug
Who is being recruted

Anxiety Disorders+10

+ Bacterial Infections and Mycoses

+ Bacterial Infections

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1993
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

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

NCT00001359
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Anxiety DisordersBacterial Infections and MycosesBacterial InfectionsMental DisordersCentral Nervous System DiseasesInfectionsMovement DisordersNervous System DiseasesGram-Positive Bacterial InfectionsNeurodevelopmental DisordersObsessive-Compulsive DisorderStreptococcal InfectionsTic Disorders

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
CompletedOne Study Center