TERMINATED

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

Conditions

PANDAS Anxiety Disorder Autoimmune Diseases Obsessive-Compulsive Disorder Children Anxiety NSAID

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2020-10-20

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04015596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 15 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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. 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). 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	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

Inclusion Criteria

Exclusion 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.
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).
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

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

Contacts and Locations

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-20

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2020-10-20

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

PANDAS
Children
Obsessive-Compulsive Disorder
Anxiety
NSAID

Additional Relevant MeSH Terms

PANDAS
Anxiety Disorder
Autoimmune Diseases
Obsessive-Compulsive Disorder