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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

Brief Summary:

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.

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
    Sponsor: Karolinska Institutet

    Current Primary Outcome: Psychiatric health of individuals assessed with the Cunningham Panel of PANS-biomarkers [ Time Frame: up to 4 years ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Sensitivity and Specificity of the Cuningham-Panel of PANS biomarkers as a diagnostic tool for PANS [ Time Frame: up to 4 years ]

    Original Secondary Outcome: Same as current

    Information By: Karolinska Institutet

    Dates:
    Date Received: June 17, 2014
    Date Started: June 2014
    Date Completion:
    Last Updated: July 4, 2016
    Last Verified: July 2016