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出境医 / 临床实验 / Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS

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

Study Description
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.
Study Design
Layout table for study information
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)
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sarah O'Dor, PhD 617-643-6688 sodor@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sarah O'Dor, PhD    617-726-8508    PANDASclinic@partners.org   
Contact: Saffron Homayoun         
Principal Investigator: Kyle Williams, MD PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE October 20, 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • PANDAS
  • Anxiety Disorder
  • Autoimmune Diseases
  • Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: Naproxen Sodium
    Dosed by weight (10mg/kg), twice daily, for 8 weeks
  • Other: Placebo
    Participants take placebo pills twice daily, for 8 weeks.
Study Arms  ICMJE
  • Experimental: Intervention
    Participants receive Naproxen Sodium.
    Intervention: Drug: Naproxen Sodium
  • Placebo Comparator: Placebo
    Participants receive placebo.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah O'Dor, PhD 617-643-6688 sodor@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015596
Other Study ID Numbers  ICMJE 2019P000623
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyle A Williams, MD, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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