Clinical Trial: Antibiotic Treatment and Intravenous Immunoglobulin Trial for PANDAS

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Antibiotic Treatment and Intravenous Immunoglobulin Double-blind, Randomized, Placebo-controlled Trial for PANDAS

Brief Summary:

An increasing body of evidence indicates that an immune basis might underline a number of pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections. More recently, several PANDAS variants have been described, including adult-onset variant. There are many evidences that OCD/tic symptoms could be due to an immunologic reaction against brain tissues following a streptococcal infection.

The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or azithromycin in case of penicillin allergy) is more effective than SSRI only.

Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin (IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment response is based on the lack of a Y-BOCS score improvement of at least 35%).

Objectives:

• To determine the safety and efficacy of SSRI+AB compared to SSRI only.
• To test the safety and additional beneficial effects of high dose of IVIG on antibiotic prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.

Study methodology:

• Participants will be screened to obtain medical history and other information at Neurologi
  

  Detailed Summary:

  Inclusion criteria for PANDAS subjects are:

  • Ages 4 -40 years

  • Presence of DSM-IV-R obsessive compulsive disorder or tic disorder and at least two of the following:

    1. Anxieties e.g. new onset separation anxiety
    2. Sensory abnormalities (tactile/auditory/visual defensiveness or visual misperceptions)
    3. Behavioral Regression (e.g. new onset impulsivity, hyperactivity, meltdowns)
    4. Deterioration in school performance or in handwriting
    5. Emotional lability and/or depression
    6. Urinary symptoms (frequent urination or enuresis)
    7. Sleep disturbances
    8. Anorexia
  • Sudden onset of symptoms or episodic course of symptom severity following infections.
  • Symptoms are of moderate severity with Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (or with the children's version for subjects below 16 years of age) of more or equal to 16 and/or Yale Global Tic Severity Scale (YGTSS) of more or equal to 21 and with significant impairment (CGI of moderate or worse).
  • Laboratory documentation of infection as documented by at least two of these: positive throat culture, documented rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB.

  Exclusion criteria for all subjects are: non-tic neurologic disorder, presence of immunologic disorder, presence of serious medical illness,
  Sponsor: CNS Onlus
  

  Current Primary Outcome: The improvement of OC/tic symptoms will be superior in patients treated with SSRI+AB and in case with IVIG, compared with those treated with SSRI+placebo, as assessed by the YBOCS/YGTSS [ Time Frame: 6 months ]
  
  

  Original Primary Outcome:

  • The improvement of OC/tic symptoms will be superior in patients treated with SSRI+AB compared with those treated with SSRI+placebo, as assesed by the YBOCS/YGTSS [ Time Frame: 6 months ]
  • IVIG treatment will improve OC/tic symproms in those patients who will not respond to AB, as assessed by the YBOCS/YGTSS [ Time Frame: 6 months ]
  
  
  

  Current Secondary Outcome:

  • The degree of treatment response is expected to correlate with the percentage reduction in antibodies titers following IVIG administration [ Time Frame: 6 months ]
  • The degree of treatment response is also expected to correlate with decreased inflammation in specific regions of the brain, as demonstrated by macroscopic changes and microstructural alterations on MRI and serum and CSF cytokines and chemokines [ Time Frame: 6 months ]
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: CNS Onlus
  

  Dates:
  Date Received: December 14, 2012
  Date Started: June 2013
  Date Completion: June 2016
  Last Updated: January 15, 2013
  Last Verified: January 2013