Naproxen Sodium for OCD in PANDAS

Overseen By Saffron Homayoun

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must not be taking: Antibiotics, SSRIs, Psychotropics, others

Disqualifiers: Psychotic, Neurological disorder, Autism, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate whether Naproxen Sodium, a common anti-inflammatory drug, can reduce OCD symptoms related to inflammation in children with PANDAS, a condition triggered by strep infections. Researchers will compare Naproxen Sodium to a placebo to determine its effectiveness in relieving these symptoms. Children aged 6-15 who recently developed OCD symptoms linked to a strep infection may be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications to join the trial. If you're on antibiotics, you'll need to stop them at least one week before starting. If you're taking SSRIs or other psychoactive medications, your dose must be stable for at least six weeks. Other psychotropic or anti-inflammatory medications may not be allowed.

What is the safety track record for Naproxen Sodium?

Previous studies have generally found Naproxen Sodium to be safe for use. This nonsteroidal anti-inflammatory drug (NSAID) often relieves pain and reduces swelling. Some individuals might experience mild side effects like an upset stomach or dizziness, but serious side effects are rare. Since the FDA has already approved Naproxen Sodium for other uses, much is known about its safety. This knowledge can reassure participants about its use in this trial for treating OCD symptoms in children with PANDAS. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for PANDAS-related OCD, which typically involve antibiotics and psychiatric medications like SSRIs, Naproxen Sodium is unique because it is a nonsteroidal anti-inflammatory drug (NSAID) that targets inflammation. Researchers are excited about Naproxen Sodium because it offers a novel approach by addressing the inflammatory aspect of PANDAS, potentially reducing symptoms more effectively. Additionally, its well-known safety profile and over-the-counter availability make it an accessible option for long-term management.

What evidence suggests that Naproxen Sodium might be an effective treatment for PANDAS?

Research has shown that Naproxen Sodium, an NSAID, might reduce OCD symptoms related to inflammation in children with PANDAS. In this trial, participants will receive either Naproxen Sodium or a placebo. Previously, patients with OCD showed improvement when Naproxen was combined with fluoxetine, suggesting that Naproxen can lessen obsessive thoughts and other OCD symptoms. While typically used for pain and swelling, Naproxen might also address immune-related inflammation, which could be important for treating PANDAS symptoms. Since Naproxen Sodium is already approved for other uses, much is known about its safety. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 6-15 with PANDAS-related OCD, showing severe symptoms like anxiety, emotional changes, learning difficulties, sleep disorders, and motoric dysfunction. They must have had a recent strep infection and not be on certain medications or treatments.

Inclusion Criteria

I am between 6 and 15 years old.

I am between 6 and 15 years old.

Obsessive-compulsive disorder can significantly interfere with your life.

Exclusion Criteria

My child is currently experiencing severe mental health issues.

You have a history of limiting how much fluid you drink, which could make side effects worse.

The child has a severe condition affecting the brain, such as brain damage, blindness, deafness, intellectual disability or autism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Naproxen Sodium or placebo for 8 weeks to evaluate the efficacy in treating OCD symptoms in children with PANDAS

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Naproxen Sodium

Trial Overview The study tests Naproxen Sodium against a placebo in kids with PANDAS to see if it reduces inflammation-related OCD symptoms. It's a double-blind trial meaning neither the participants nor the researchers know who gets the real medicine or placebo.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants receive Naproxen Sodium.

Group II: Placebo Placebo Group 1 Intervention

Participants receive placebo.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04015596

Trial of Naproxen Sodium for the Treatment of OCD in ... 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 ...

2. withpower.com withpower.com/trial/phase-4-anxiety-disorders-9-2020-2b991

Naproxen Sodium for OCD in PANDAS · Info for Participants This trial tests Naproxen Sodium, an anti-inflammatory drug, to see if it can reduce OCD symptoms in children with PANDAS. These children have OCD symptoms ...

3. aspire.care aspire.care/blog/recruiting-naproxen-sodium-treat-obsessive-compulsive-symptoms-in-patients-with-pediatric-autoimmune-neuropsychiatric-disorder-associated-with-streptococcal-infections-pandas/

Recruiting - naproxen sodium treat obsessive-compulsive ... What we are studying: This study evaluates the efficacy of naproxen sodium treat OCD symptoms in patients with suspected or diagnosed Pediatric ...

4. oregon.gov oregon.gov/oha/HPA/DSI-HERC/EvidenceBasedReports/PANDAS-PANS_Coverage-Guidance_FINALapproved_5-19-2022.pdf

Health Evidence Review Commission (HERC) Up to 3 monthly immunomodulatory courses of intravenous immunoglobulin (IVIG) therapy are recommended for coverage to treat PANDAS and PANS ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39354696/

Naproxen adjunct to fluoxetine for moderate-to-severe ... Conclusion: Naproxen, adjunct to fluoxetine, outperformed adjunctive placebo in treating obsession and total symptoms of OCD patients in a safe ...

6. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/treatment_for_pandas

Children with PANDAS wanted for clinical trial This study evaluates the efficacy of naproxen sodium treat obsessive-compulsive symptoms in patients with Pediatric Autoimmune Neuropsychiatric Disorder

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7801912/

Investigational and Experimental Drugs to Treat Obsessive ... Naproxen and Immunoglobulins for PANS/PANDAS​​ As mentioned in the previous sections, a subset of pediatric-onset OCD is considered to be related ...

8. med.stanford.edu med.stanford.edu/content/dam/sm/nbc/documents/journalclub/2023/OCDpsychopharm2022.pdf

Treatment-resistant OCD - Stanford Medicine Taken together, the opiate literature in OCD does not suggest a high risk for medication-seeking behavior or de novo prescription drug use.