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Trial record 63 of 1725 for:    Recruiting, Not yet recruiting, Available Studies | Autoimmunity

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

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ClinicalTrials.gov Identifier: NCT04015596
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle A Williams, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
PANDAS Anxiety Disorder Autoimmune Diseases Obsessive-Compulsive Disorder Drug: Naproxen Sodium Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020


Arm Intervention/treatment
Experimental: Intervention
Participants receive Naproxen Sodium.
Drug: Naproxen Sodium
Dosed by weight (10mg/kg), twice daily, for 8 weeks

Placebo Comparator: Placebo
Participants receive placebo.
Other: Placebo
Participants take placebo pills twice daily, for 8 weeks.




Primary Outcome Measures :
  1. Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II) [ Time Frame: Pre- to Post-8 week treatment ]
    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.

  2. Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I) [ Time Frame: Pre- to Post-8 week treatment ]
    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.


Secondary Outcome Measures :
  1. Changes in C reactive protein pre- and post-treatment between groups [ Time Frame: Pre- to Post-8 week treatment ]
    C reactive protein (CRP, mg/L) will be obtained from pre- and post-blood draws and will be compared between groups.

  2. Changes in erythrocyte sedimentation rate pre- and post-treatment between groups [ Time Frame: Pre- to Post-8 week treatment ]
    Erythrocyte sedimentation rate (ESR, mm/h) will be obtained from pre- and post-blood draws and will be compared between groups.



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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

These co-occurring symptoms must be "severe" or "dramatic" and proceed from no/minimal symptoms to maximum severity within the same 24-48 hour interval during which the OCD symptoms arose. In addition to these inclusion criteria, PANDAS subjects will be required to provide documentation of a positive GAS infection via medical records. As the time between a documented GAS infection and the onset of PANDAS symptoms has not been defined in the PANDAS diagnostic criteria, the investigators will use a guideline of approximately six weeks or less between a documented GAS infection and the onset of OCD symptoms for inclusion into the study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015596


Contacts
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Contact: Sarah O'Dor, PhD 617-643-6688 sodor@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Kyle A Williams, MD, PhD, Director, Pediatric Neuropsychiatry and Immunology Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04015596     History of Changes
Other Study ID Numbers: 2019P000623
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kyle A Williams, MD, PhD, Massachusetts General Hospital:
PANDAS
Children
Obsessive-Compulsive Disorder
Anxiety
NSAID
Additional relevant MeSH terms:
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Autoimmune Diseases
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Personality Disorders
Immune System Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action