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Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)

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ClinicalTrials.gov Identifier: NCT03507218
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

Background:

PANS is an illness that comes on suddenly in children. The full name is Pediatric Acute-Onset Neuropsychiatric Syndrome. It can cause sudden obsessive-compulsive behaviors. It can also cause children to suddenly restricte their food intake. Researchers want to learn more about children with PANS. They also want to learn more about the illness.

Objective:

To study some disorders of behavior and emotion that start in childhood.

Eligibility:

Children 3 14 years old who have had severe obsessive-compulsive symptoms or food restriction start quickly

Design:

Parents will answer questions. The topics include:

Their child s medical history

Their child s physical and mental health

Their family history. The focus will be on neurodevelopmental and psychiatric conditions. A family tree will be drawn.

Participants will have a physical exam.

Participants may take tests on paper or computer. These will focus on thinking, memory, and behavior.

Participants and parents will give a blood sample.

Participants will have magnetic resonance imaging (MRI). A strong magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides in and out of a metal scanner.

Participants may have photos or videos taken.

Participants may have other tests. These may include heart tests, sleep tests, and lumbar puncture.

Sponsoring Institute: National Institute of Mental Health

...


Condition or disease
Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 6400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical, Laboratory, and Biomedical Characterization of Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 31, 2030


Group/Cohort
1
Children with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)



Primary Outcome Measures :
  1. Establish national database and samples repository for pediatric acute-onset neuropsychiatric syndrome (PANS) [ Time Frame: Study Completion ]

Secondary Outcome Measures :
  1. Identify unique and distinctive features of subgroups of patients with PANS, in order to determine the shared disease mechanism [ Time Frame: Study completion ]
  2. Elucidate the role of immune dysfunction in the syndrome of PANS, as well as for subgroups of patients [ Time Frame: Study completion ]
  3. Determine role of environmental pathogens, such as Group A streptococci, in the etiopathogenesis of PANS [ Time Frame: Study completion ]
  4. Investigate factors influencing host susceptibility and resistance [ Time Frame: Study completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
study population will include potential participants from primary care and specialty medical referrals, community samples, and self-referral from across the United States.
Criteria
  • INCLUSION CRITERIA:

Affected Probands (Children with PANS) will be eligible if they:

  1. Are 3 to 14 years of age (initial enrollment must occur prior
  2. Have a history of abrupt onset (less than 24-48 hours) of impairing OCD and/or eating restrictions.
  3. Are able to travel safely to the regional medical center where the evaluations will be conducted and are able to be examined safely over a period of one or more days.
  4. Assent to participate (if they are at least seven years old and have capacity to do so) and have legal guardians who consent to their minor child s participation.
  5. Are under the care of a primary physician in their home community.

First-degree Relatives will be eligible if they:

  1. Are a biologic parent or sibling of an affected proband.
  2. Consent (or assent) to undergo study evaluations and to provide blood, microbial and genetic samples.

Children with Non-PANS Neuropsychiatric Symptoms may be enrolled if they:

  1. Are 3 to 14 years of age (initial enrollment must occur prior to the participant s 15th birthday to permit prospective longitudinal evaluations)
  2. Have OCD, tics, anxiety disorders, or other psychiatric symptoms, but do NOT have a history of acute symptom onset.
  3. Are willing to participate in medical, psychiatric, and behavioral assessments and to provide bio-specimens including blood, urine, and microbial flora (mouth, oropharynx, and/or stool).
  4. Assent to participate (if they are at least seven years old and have capacity to do so) and have legal guardians who consent to their minor child s participation.
  5. Are under the care of a primary physician in their home community.

Healthy Pediatric Volunteers may be enrolled if they:

  1. Are 3 to 14 years of age (initial enrollment must occur prior to the participant s 15th birthday to permit prospective longitudinal evaluations).
  2. Are physically healthy and do not have psychiatric symptoms.
  3. Are willing to participate in medical, psychiatric, and behavioral assessments and to provide bio-specimens including blood, urine, and microbial flora (mouth, oropharynx, and/or stool).
  4. Assent to participate (if they are at least seven years old and have capacity to do so) and have legal guardians who consent to their minor child s participation.

EXCLUSION CRITERIA:

Participants will not be eligible if they:

  1. Appear to the investigators to be too unstable psychiatrically or medically to participate safely in the protocol.
  2. Are unwilling or unable to be evaluated and followed prospectively.
  3. Have a parent/guardian who is not willing to participate at a distance through web-based or phone-based data collection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507218


Contacts
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Contact: Margaret J Pekar (301) 402-1084 pekarm@mail.nih.gov

Locations
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United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
United States, California
Lucille Salter Packer Children's Hospital Recruiting
Stanford, California, United States, 94304
United States, Delaware
Nemours/Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
United States, Florida
University of Southern Florida Recruiting
Tampa, Florida, United States, 33620
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
United States, Massachusetts
Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55415
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65205
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Susan E Swedo, M.D. National Institute of Mental Health (NIMH)

Additional Information:
Publications:
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT03507218     History of Changes
Other Study ID Numbers: 180036
18-M-0036
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 29, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Obsessive Compulsive Disorder
Anxiety Disorder
PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated d
Eating Disorders

Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes