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

NCT ID: NCT04015596

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2025-04-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Participants receive Naproxen Sodium.

Group Type: EXPERIMENTAL

Naproxen Sodium

Intervention Type: DRUG

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

Placebo

Participants receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants take placebo pills twice daily, for 8 weeks.

Interventions

Naproxen Sodium

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

Intervention Type: DRUG

Placebo

Participants take placebo pills twice daily, for 8 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. significantly interfering Obsessive-Compulsive Disorder (OCD) symptoms

2. ages 6- to 15-years-old

3. new-onset of OCD symptoms within the previous 18 months

4. sufficient fluency of English to understand study staff, procedures and questionnaires,

5. able to take medication in pill form

6. parent/legal guardian who can provide informed consent.

Patients must also meet all criteria for PANDAS, which are:

1. prepubertal symptom onset

2. acute onset of symptoms (from no/minimal symptoms to maximum severity within 24-48 hours) and/or an episodic (relapsing-remitting) course

3. temporal association between symptomatic periods and infections with Group A Streptococcus (GAS) infection

4. 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:

1. Markedly increased level of anxiety, particularly new onset of separation anxiety

2. Emotional lability, irritability, aggressive behavior and/or personality change

3. Sudden difficulties with concentration or learning

4. Developmental regression ("baby-talk", temper tantrums).

5. Sleep disorder (insomnia, night terrors, refusal to sleep alone)

6. Handwriting deterioration or other sign of motoric dysfunction (including new onset of motor hyperactivity, presence of choreiform finger movements, pronator drift or truncal instability)

7. Urinary frequency or increased urge to urinate; daytime or night-time secondary enuresis

Exclusion Criteria

1. child who is acutely psychotic or suicidal

2. child has a serious neurological disorder or impairment (e.g. brain damage, blindness, deafness), an intellectual disability, or autism

3. history of immune modulating therapies for OCD/PANDAS symptoms

4. pre-existing liver, kidney, GI bleeding or clotting disorders (GFR <75 mL/min/1.73m2)

5. history of ulcers in the digestive system

6. history of restricted fluid intake, as this could exacerbate side effects

7. concurrent antibiotic treatment or antibiotic treatment within one-week of baseline

8. pregnant or becomes pregnant

9. currently engaged in an intensive outpatient cognitive behavioral treatment program (more than weekly)

10. 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)

11. concurrent medications that do not meet the above criteria (e.g., other psychotropic medications or anti-inflammatory agents)

12. history of severe asthma or currently uncontrolled asthma

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyle A Williams, MD, PhD

Director, Pediatric Neuropsychiatry and Immunology Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019P000623

Identifier Type: -

Identifier Source: org_study_id