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

Ki vehet részt

• significantly interfering Obsessive-Compulsive Disorder (OCD) symptoms
• ages 6- to 15-years-old
• new-onset of OCD symptoms within the previous 18 months
• sufficient fluency of English to understand study staff, procedures and questionnaires,
• able to take medication in pill form
• parent/legal guardian who can provide informed consent; Patients must also meet all criteria for PANDAS, which are:
• prepubertal symptom onset
• acute onset of symptoms (from no/minimal symptoms to maximum severity within 24-48 hours) and/or an episodic (relapsing-remitting) course
• temporal association between symptomatic periods and infections with Group A Streptococcus (GAS) infection
• presence of neurological abnormalities (e.g. handwriting deterioration, choreiform movements); The onset/exacerbation of OCD symptoms must also be accompanied by at least three of the following clinical signs and symptoms, including:
• Markedly increased level of anxiety, particularly new onset of separation anxiety
• Emotional lability, irritability, aggressive behavior and/or personality change
• Sudden difficulties with concentration or learning
• Developmental regression ("baby-talk", temper tantrums)
• Sleep disorder (insomnia, night terrors, refusal to sleep alone)
• Handwriting deterioration or other sign of motoric dysfunction (including new onset of motor hyperactivity, presence of choreiform finger movements, pronator drift or truncal instability)
• Urinary frequency or increased urge to urinate; daytime or night-time secondary enuresis; These co-occurring symptoms must be "severe" or "dramatic" and proceed from no/minimal symptoms to maximum severity within the same 24-48 hour interval during which the OCD symptoms arose. In addition to these inclusion criteria, PANDAS subjects will be required to provide documentation of a positive GAS infection via medical records. As the time between a documented GAS infection and the onset of PANDAS symptoms has not been defined in the PANDAS diagnostic criteria, the investigators will use a guideline of approximately six weeks or less between a documented GAS infection and the onset of OCD symptoms for inclusion into the study

Ki nem vehet részt

• concurrent antibiotic treatment or antibiotic treatment within one-week of baseline
• 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)
• concurrent medications that do not meet the above criteria (e.g., other psychotropic medications or anti-inflammatory agents)
• child has a serious neurological disorder or impairment (e.g. brain damage, blindness, deafness), an intellectual disability, or autism
• history of immune modulating therapies for OCD/PANDAS symptoms
• history of ulcers in the digestive system
• history of restricted fluid intake, as this could exacerbate side effects
• history of severe asthma or currently uncontrolled asthma
• pre-existing liver, kidney, GI bleeding or clotting disorders (GFR <75 mL/min/1.73m2)
• child who is acutely psychotic or suicidal
• pregnant or becomes pregnant
• currently engaged in an intensive outpatient cognitive behavioral treatment program (more than weekly)