Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS

Eligibility Criteria

• 1. significantly interfering Obsessive-Compulsive Disorder (OCD) symptoms
• 2. ages 6- to 15-years-old
• 3. new-onset of OCD symptoms within the previous 18 months
• 4. sufficient fluency of English to understand study staff, procedures and questionnaires,
• 5. able to take medication in pill form
• 6. parent/legal guardian who can provide informed consent.
• 1. prepubertal symptom onset
• 2. acute onset of symptoms (from no/minimal symptoms to maximum severity within 24-48 hours) and/or an episodic (relapsing-remitting) course
• 3. temporal association between symptomatic periods and infections with Group A Streptococcus (GAS) infection
• 4. presence of neurological abnormalities (e.g. handwriting deterioration, choreiform movements).
• 1. Markedly increased level of anxiety, particularly new onset of separation anxiety
• 2. Emotional lability, irritability, aggressive behavior and/or personality change
• 3. Sudden difficulties with concentration or learning
• 4. Developmental regression ("baby-talk", temper tantrums).
• 5. Sleep disorder (insomnia, night terrors, refusal to sleep alone)
• 6. Handwriting deterioration or other sign of motoric dysfunction (including new onset of motor hyperactivity, presence of choreiform finger movements, pronator drift or truncal instability)
• 7. Urinary frequency or increased urge to urinate; daytime or night-time secondary enuresis
• 1. child who is acutely psychotic or suicidal
• 2. child has a serious neurological disorder or impairment (e.g. brain damage, blindness, deafness), an intellectual disability, or autism
• 3. history of immune modulating therapies for OCD/PANDAS symptoms
• 4. pre-existing liver, kidney, GI bleeding or clotting disorders (GFR \<75 mL/min/1.73m2)
• 5. history of ulcers in the digestive system
• 6. history of restricted fluid intake, as this could exacerbate side effects
• 7. concurrent antibiotic treatment or antibiotic treatment within one-week of baseline
• 8. pregnant or becomes pregnant
• 9. currently engaged in an intensive outpatient cognitive behavioral treatment program (more than weekly)
• 10. concurrent selective serotonin reuptake inhibitor (SSRI) or other psychoactive medication treatment except and unless the dose has been stable for at least 6 weeks (i.e. no recent titration, initiation, or change in dosage)
• 11. concurrent medications that do not meet the above criteria (e.g., other psychotropic medications or anti-inflammatory agents)
• 12. history of severe asthma or currently uncontrolled asthma