Anti-Inflammatory drug studied for PANDAS-Related OCD in kids
NCT ID NCT04015596
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the anti-inflammatory drug naproxen sodium for treating obsessive-compulsive symptoms in children aged 6-15 with PANDAS, a condition linked to strep infections. The trial was double-blind and placebo-controlled, but it was terminated early after enrolling only 2 participants. No results are available to determine if naproxen helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naproxen sodium (an anti-inflammatory drug)
- What this could lead to
- If it had worked, this could have pointed toward an anti-inflammatory treatment for OCD symptoms in children with PANDAS.
- What could go wrong
- The trial was terminated early with only 2 participants, so no conclusions can be drawn. It is unclear if naproxen is effective or safe for this condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
2 people
The number who actually took part.
- Started
-
Oct 2020
- Finished
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Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 15 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Patients must also meet all criteria for PANDAS, which are: 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). The onset/exacerbation of OCD symptoms must also be accompanied by at least three of the following clinical signs and symptoms, including: 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 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 Criteria: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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