PANDASPhase 4NCT04015596
Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS
A Phase 4 study testing Naproxen Sodium in people with PANDAS and Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- PANDAS, Anxiety Disorder, Autoimmune Diseases
- What is being tested?
- Naproxen Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled Trial of Naproxen Sodium for the Treatment of Obsessive Compulsive Symptoms in Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infections (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-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.
Read the 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 in the treatment of children with PANDAS. The study will involve an 8-week, double-blinded randomized controlled trial to evaluate the efficacy of naproxen sodium (10mg/kg, by mouth, twice a day) versus placebo to treat OCD symptoms in children with PANDAS. The investigators will acquire completed data on 44 children with PANDAS for this pilot study (i.e., 22 randomized to active treatment; 22 randomized to placebo). Outcome will be assessed comparing pre- and post-treatment OCD symptom severity using a standardized, clinician-administered interview assessing OCD symptoms by an independent rater blind to treatment assignment.
- Being tested
- Naproxen Sodium, Placebo
- Keywords
- PANDAS, Children, Obsessive-Compulsive Disorder, Anxiety, NSAID
- Medical subject headings
- Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections, Anxiety Disorders, Autoimmune Diseases, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen SodiumDrug
Dosed by weight (10mg/kg), twice daily, for 8 weeks
PlaceboOther
Participants take placebo pills twice daily, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive Naproxen Sodium. Receives: Drug: Naproxen Sodium |
| Placebo | Placebo comparator | Participants receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive Symptom Severity Measured by Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II)
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.
Measured: Pre- to Post-8 week treatment
Obsessive-compulsive Symptom Severity Measured by Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)
The CY-BOCS-I is a clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsion, each ranging from 0-20, with a higher score indicating more symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 40, that is used to measure overall OCD symptom severity.
Measured: Pre- to Post-8 week treatment
Secondary outcomes (2)
Changes in C Reactive Protein Pre- and Post-treatment Between Groups
C reactive protein (CRP, mg/L) will be obtained from pre- and post-blood draws and will be compared between groups.
Measured: Pre- to Post-8 week treatment
Changes in Erythrocyte Sedimentation Rate Pre- and Post-treatment Between Groups
Erythrocyte sedimentation rate (ESR, mm/h) will be obtained from pre- and post-blood draws and will be compared between groups.
Measured: Pre- to Post-8 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start20 Oct 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PANDASStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle A Williams, MD, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015596
- Sponsor's protocol ID
- 2019P000623
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2019
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled Trial of Naproxen Sodium for the Treatment of Obsessive Compulsive Symptoms in Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infections (PANDAS)
- ClinicalTrials.gov ID
- NCT04015596
- Acronym / sponsor ID
- 2019P000623
- Keywords
- PANDAS, Children, Obsessive-Compulsive Disorder, Anxiety, NSAID
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 in the treatment of children with PANDAS. The study will involve an 8-week, double-blinded randomized controlled trial to evaluate the efficacy of naproxen sodium (10mg/kg, by mouth, twice a day) versus placebo to treat OCD symptoms in children with PANDAS. The investigators will acquire completed data on 44 children with PANDAS for this pilot study (i.e., 22 randomized to active treatment; 22 randomized to placebo). Outcome will be assessed comparing pre- and post-treatment OCD symptom severity using a standardized, clinician-administered interview assessing OCD symptoms by an independent rater blind to treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Naproxen SodiumParticipants receive Naproxen Sodium. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive placebo. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen SodiumDosed by weight (10mg/kg), twice daily, for 8 weeks | Drug | Intervention |
| PlaceboParticipants take placebo pills twice daily, for 8 weeks. | Other | Placebo |
Primary outcome
Obsessive-compulsive Symptom Severity Measured by Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II)
Time frame: Pre- to Post-8 week treatment
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.
Obsessive-compulsive Symptom Severity Measured by Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)
Time frame: Pre- to Post-8 week treatment
The CY-BOCS-I is a clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsion, each ranging from 0-20, with a higher score indicating more symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 40, that is used to measure overall OCD symptom severity.
2 secondary outcomes
Changes in C Reactive Protein Pre- and Post-treatment Between Groups
Time frame: Pre- to Post-8 week treatment
Changes in Erythrocyte Sedimentation Rate Pre- and Post-treatment Between Groups
Time frame: Pre- to Post-8 week treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for PANDAS
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PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study
PANS, PANDAS
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Post-Acute COVID-19 Syndrome, ME/CFS
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Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS
Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen Sodium in people with PANDAS and Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-compulsive Symptom Severity Measured by Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II) (time frame: Pre- to Post-8 week treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.