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NCT04015596 · ClinicalTrials.gov registry record · Phase 4
Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT04015596: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT04015596 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04015596, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
The CY-BOCS-II is a clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsion, each ranging from 0-25, with a higher score indicating more symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 50, that is used to measure overall OCD symptom severity.
Interventions
- OTHER Placebo
- DRUG Naproxen Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 4 |
Why NCT04015596 stopped before completion
NCT04015596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04015596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04015596 about?
NCT04015596 is a clinical study titled "Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS". 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-infla...
What is the current status of trial NCT04015596?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2020-10-20. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT04015596?
The interventions under investigation include: Placebo (OTHER), Naproxen Sodium (DRUG).
Who is sponsoring clinical trial NCT04015596?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04015596's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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