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

NCT04015596 | Terminated Phase 4 FDA Drug

• 1 other identifier: 2019P000623
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PANDAS; Anxiety Disorder; Autoimmune Diseases; Obsessive-Compulsive Disorder

Keywords

PANDAS; Children; Obsessive-Compulsive Disorder; Anxiety; NSAID

Outcome Measures

Primary Outcomes (2)

• 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.

  Pre- to Post-8 week treatment

• 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.

  Pre- to Post-8 week treatment

Secondary Outcomes (2)

• Changes in C reactive protein pre- and post-treatment between groups

  Pre- to Post-8 week treatment

• Changes in erythrocyte sedimentation rate pre- and post-treatment between groups

  Pre- to Post-8 week treatment

Study Arms (2)

Intervention

EXPERIMENTAL

Participants receive Naproxen Sodium.

Drug: Naproxen Sodium

Placebo

PLACEBO COMPARATOR

Participants receive placebo.

Other: Placebo

Interventions

Naproxen Sodium DRUG

Dosed by weight (10mg/kg), twice daily, for 8 weeks

Intervention

Placebo OTHER

Participants take placebo pills twice daily, for 8 weeks.

Placebo

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections; Anxiety Disorders; Autoimmune Diseases; Obsessive-Compulsive Disorder

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Mental Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Neuropsychiatry and Immunology Program

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 11, 2019
• Study Start: October 20, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)