TerminatedPhase 4

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

Stopped: Low recruitment

United States5 participantsStarted 2020-10-20

Plain-language 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 conduct a double-blind, randomized, placebo-controlled trial of Naproxen Sodium, a nonsteroidal anti-inflammatory drug (NSAID) in participants diagnosed with Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal infections (PANDAS). This research fills a gap in the empirical evidence base for the treatment of PANDAS, and will add to a growing literature of empirically-derived practices for PANDAS.

Who can participate

Age range6 Years – 15 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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

Exclusion criteria

✕. 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

What they're measuring

Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II)

Timeframe: Pre- to Post-8 week treatment

Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)

Timeframe: Pre- to Post-8 week treatment

Trial details

NCT IDNCT04015596

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

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