Completed

NCT Number: NCT02190292

PANS - A Detailed Study of the Patients, Their Symptoms, Biomarkers and Treatment Offered in a Scandinavian Cohort

Background: Obsessive-compulsive disorder (OCD) is considered one of the most debilitating of the psychiatric illnesses, yet much remains unclear regarding causes and cures. A diagnostic subgroup with acute onset of obsessive-compulsive symptoms (and sometimes tics or anorexia nervosa) possibly due to an autoimmune response, has been entitled Pediatric Acute onset Neuropsychiatric Syndrome (PANS). PANS is sometimes treated with immunomodulatory therapy or antibiotics, with a variable outcome. A diagnosis of PANS is supported by elevated levels of auto-antibodies and antibody-enzyme activity measured with the Cunningham panel, but the relationship between these biomarkers and the patients' symptoms remains unclear. A clinician rated symptom scale for PANS (the PANS scale) has been developed, but needs to be further evaluated regarding sensitivity and specificity.

Aims:

* To assess a Swedish cohort of patients diagnosed with PANS and compile their psychiatric health status, biomarkers, psychiatric symptoms, soft neurological signs and treatment outcomes in a systematic way * To compare psychiatric health status, biomarkers and psychiatric, neurologic and motor symptoms in this PANS cohort with a control group of psychiatric patients and with healthy children. * To evaluate the Cunningham panel as a diagnostic tool for PANS. * To evaluate a clinician rated symptom scale (the PANS scale) as a diagnostic tool for PANS.

Method: Observational study Participants: Patients (n≈150) who have been tested with the Cunningham panel of PANS biomarkers in Sweden (or Swedish patients tested in Denmark) will be asked to participate.

Procedure: Assessment of current symptoms, psychiatric health, neurological and motor symptoms and possible biomarkers for PANS will be collected for all patients. Retrospective assessment through interview and medical records, including results from the first assessment with the Cunningham panel of PANS-biomarkers is made with all patients. 50 out of the total PANS cohort of 150 patients will be re-tested with the Cunningham panel. A control group consisting of psychiatric patients (n=60) and healthy children (n=25) will be examined with a similar test battery and signs and symptoms will be compared with the PANS group.

Significance:

Previous and current symptoms of PANS, levels of PANS biomarkers and treatment outcome will be investigated, thus knowledge regarding long-term outcome and evidence for the use of clinical assessment tools and biomarkers for diagnosing PANS will be gained.

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Key information

Conditions

Obsessive-compulsive Disorder With Acute Onset Anxiety Disorders Childhood Acute Neuropsychiatric Symptoms (CANS) Mental Disorders Obsessive-Compulsive Disorder PANDAS Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections Pediatric acute-onset neuropsychiatric syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Stockholm psychiatry

Stockholm, Sverige, SE-112 81, Sweden

About this study

Data collected comprises:

Retrospective data

Interview
Medical records
Five to Fifteen (FTF)
Cunningham panel of PANS biomarkers result prior to inclusion (at time point 1)
Change in Clinical Global Impression-Improvement (CGI-I) since the first assessment of the Cunningham panel

Current data

Current levels of Cunningham panel of PANS biomarkers

Cunningham panel of PANS biomarkers at time point 2

Current neuropsychiatric status

Psychiatric interview
PANS symptom scale

Standardized assessment for children:

Child behavior checklist (CBCL)
The Autism spectrum Quotient: Children's version (AQ-Child)
Brief Obsessive-Compulsive Scale (BOCS)
Mini international Neuropsychiatric Interview - KID (M.I.N.I. KID)
Five to Fifteen (FTF)

Standardized assessment for adults:

Schizotypal Personality Disorder Questionnaire (SPQ)
Liebowitz social anxiety scale (LSAS)
The Autism spectrum Quotient (AQ)
Adult ADHD Self-Report Scale (ASRS)
Brown Attention-Deficit Disorder Scales (Brown ADD Scales)
Quality of Life Inventory (QOLI)
Brief obsessive-compulsive scale (BOCS)
Mini international Neuropsychiatric Interview (M.I.N.I.)
FTF retrospective data

Current soft neurological signs

Alternating skips
Romberg's balance test
Diadochokinesia
Involuntary finger movements

Current neuropsychological status

Drawing exercises
Writing exercises
WAIS/WISC Block design
WAIS/WISC Digit Span
WAIS/WISC Letter Number Sequencing
WAIS/WISC Digit Symbol Coding

Current biomarkers in blood/serum

D8/17 antigen expression
Human leukocyte antigen (HLA)
C-reactive protein (CRP)
T-cell activation
Human proteome serum analysis

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

the PANS-group:

Scandinavian patients assessed with the Cunningham panel through Wieslab, Lund, Sweden or Statens Serum Institut (SSI), Copenhagen, Denmark.

Exclusion criteria

PANS-group:

intellectual disability, non-Swedish speaking

Inclusion criteria

Psychiatric Controls:

diagnosed with a psychiatric disorder
age <40 years

Exclusion criteria

Psychiatric Controls:

intellectual disability, non-Swedish speaking

Inclusion criteria

Healthy Controls:

age and sex matched to the PANS-group

Exclusion criteria

Healthy controls:

intellectual disability, non-Swedish speaking

Treatment and study plan

Primary outcomes

Psychiatric health of individuals assessed with the Cunningham Panel of PANS-biomarkers

Time frame: up to 4 years

Secondary outcomes

Sensitivity and Specificity of the Cuningham-Panel of PANS biomarkers as a diagnostic tool for PANS

Time frame: up to 4 years

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

The Swedish Research Council

Registry information

Important dates

Study start: 2014
Primary completion: 2017
First posted: Jul 15, 2014
Registry last updated: Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed