Naproxen Sodium for OCD in PANDAS

Overseen By Saffron Homayoun

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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 linked to inflammation from streptococcal infections. The medication aims to lower inflammation, potentially easing their symptoms.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+