Status:
TERMINATED
Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS
Lead Sponsor:
Massachusetts General Hospital
Conditions:
PANDAS
Anxiety Disorder
Eligibility:
All Genders
6-15 years
Phase:
PHASE4
Brief Summary
This project aims to rigorously evaluate a potential treatment for inflammation-related Obsessive-Compulsive Disorder (OCD) symptoms in children. To accomplish this goal, the investigators will conduc...
Detailed Description
The investigators propose to systematically evaluate the effects of naproxen sodium on anti-obsessional and behavioral improvement and conduct the first randomized controlled trial of naproxen sodium ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- child who is acutely psychotic or suicidal
- 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
- pre-existing liver, kidney, GI bleeding or clotting disorders (GFR \<75 mL/min/1.73m2)
- history of ulcers in the digestive system
- history of restricted fluid intake, as this could exacerbate side effects
- concurrent antibiotic treatment or antibiotic treatment within one-week of baseline
- pregnant or becomes pregnant
- currently engaged in an intensive outpatient cognitive behavioral treatment program (more than weekly)
- 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)
- history of severe asthma or currently uncontrolled asthma
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04015596
Start Date
October 20 2020
End Date
April 30 2025
Last Update
September 25 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114