Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)

NCT03507218 | Terminated

• 2 other identifiers: 18003618-M-0036
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 8

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

Conditions

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)

Keywords

Obsessive Compulsive Disorder; Anxiety Disorder; PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated d; Eating Disorders

Outcome Measures

Primary Outcomes (1)

• Establish national database and samples repository for pediatric acute-onset neuropsychiatric syndrome (PANS)

  Study Completion

Secondary Outcomes (4)

• Identify unique and distinctive features of subgroups of patients with PANS, in order to determine the shared disease mechanism

  Study completion

• Elucidate the role of immune dysfunction in the syndrome of PANS, as well as for subgroups of patients

  Study completion

• Determine role of environmental pathogens, such as Group A streptococci, in the etiopathogenesis of PANS

  Study completion

• Investigate factors influencing host susceptibility and resistance

  Study completion

Study Arms (1)

1

Children with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Affected Probands (Children with PANS) will be eligible if they:
• Are 3 to 14 years of age (initial enrollment must occur prior
• Have a history of abrupt onset (less than 24-48 hours) of impairing OCD and/or eating restrictions.
• 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.
• 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.
• Are under the care of a primary physician in their home community.
• First-degree Relatives will be eligible if they:
• Are a biologic parent or sibling of an affected proband.
• 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:
• Are 3 to 14 years of age (initial enrollment must occur prior to the participant s 15th birthday to permit prospective longitudinal evaluations)
• Have OCD, tics, anxiety disorders, or other psychiatric symptoms, but do NOT have a history of acute symptom onset.
• 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).
• 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.
• Are under the care of a primary physician in their home community.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (8)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Lucille Salter Packer Children's Hospital

Stanford, California, 94304, United States

Location

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

University of Southern Florida

Tampa, Florida, 33620, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55415, United States

Location

University of Missouri

Columbia, Missouri, 65205, United States

Location

Related Publications (2)

• Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE; PANS Collaborative Consortium. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015 Feb;25(1):3-13. doi: 10.1089/cap.2014.0084. Epub 2014 Oct 17.

  PMID: 25325534 BACKGROUND

• Williams KA, Swedo SE. Post-infectious autoimmune disorders: Sydenham's chorea, PANDAS and beyond. Brain Res. 2015 Aug 18;1617:144-54. doi: 10.1016/j.brainres.2014.09.071. Epub 2014 Oct 7.

  PMID: 25301689 BACKGROUND

MeSH Terms

Conditions

Pediatric acute-onset neuropsychiatric syndrome; Obsessive-Compulsive Disorder; Anxiety Disorders; Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan E Swedo, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: April 25, 2018
• Study Start: March 20, 2018
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

US (8)