Naproxen Sodium for Autoimmune Diseases

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Massachusetts General Hospital, Boston, MA
Autoimmune Diseases+5 More
Naproxen Sodium - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a common over-the-counter drug may help reduce symptoms of obsessive-compulsive disorder.

See full description

Eligible Conditions

  • Autoimmune Diseases
  • Obsessive-Compulsive Disorder
  • PANDAS
  • Anxiety Disorders

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Autoimmune Diseases

Study Objectives

This trial is evaluating whether Naproxen Sodium will improve 2 primary outcomes and 2 secondary outcomes in patients with Autoimmune Diseases. Measurement will happen over the course of Pre- to Post-8 week treatment.

Week 8
Changes in C reactive protein pre- and post-treatment between groups
Changes in erythrocyte sedimentation rate pre- and post-treatment between groups
Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)
Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Autoimmune Diseases

Side Effects for

Naproxen Sodium
Vomiting
5%
Wisdom Teeth Extraction Pain
5%
Left Arm Numbness
5%
Kidney Stone Pain Flare
5%
Back Pain
5%
Left Hand Numbness
5%
Right Chest Wall Pain
5%
Neck Pain
5%
Left Arm Pain
5%
Sinusitis
5%
Allergic Rhinitis
0%
Diarrhea
0%
Insomnia
0%
Root Canal Pain
0%
Fever
0%
Allodynia
0%
Cough
0%
Stiffness in neck
0%
Nasal Congestion
0%
Weight Gain
0%
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT01300546) in the Naproxen Sodium ARM group. Side effects include: Vomiting with 5%, Wisdom Teeth Extraction Pain with 5%, Left Arm Numbness with 5%, Kidney Stone Pain Flare with 5%, Back Pain with 5%.

Trial Design

2 Treatment Groups

Intervention
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Naproxen Sodium is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Intervention
Drug
Participants receive Naproxen Sodium.
Placebo
Other
Participants receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre- to post-8 week treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly pre- to post-8 week treatment for reporting.

Who is running the study

Principal Investigator
K. A. W.
Kyle A Williams,, MD PhD
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A symptom that starts during the prepubertal stage. show original
The symptoms get worse very quickly, within 24 to 48 hours, and they keep coming back. show original
patients and their family members Researchers found a link between the occurrence of GAS infections and the periods when patients experienced symptoms show original
There are neurological abnormalities present, such as deterioration in handwriting and choreiform movements. show original
Obsessive-compulsive disorder can significantly interfere with your life. show original
ages 6- to 15-years-old
Symptoms of OCD that started within the last 18 months. show original
sufficient fluency of English to understand study staff, procedures and questionnaires
able to take medication in pill form
A parent or legal guardian who can provide informed consent is eligible to participate in the study. show original

Patient Q&A Section

Does obsessive-compulsive disorder run in families?

"OCD runs as a familial disease in certain families. The data are consistent with the concept that shared genetic susceptibility leads to similar OCD-like phenotypes across families, while other environmental or nonshared factors underlie the presence of family-specific OCD phenotypes." - Anonymous Online Contributor

Unverified Answer

What causes obsessive-compulsive disorder?

"The causes of both OCD and ADHD are poorly understood. Studies of comorbidity have found the prevalence of OCD and ADHD to be relatively high, suggesting that the two disorders may share risk factors." - Anonymous Online Contributor

Unverified Answer

What are the signs of obsessive-compulsive disorder?

"Symptoms of OCD include obsessions, and compulsions that may appear at any time of the day or for any reason. Those with OCD can get obsessions from all sorts of things, such as seeing, hearing, or recalling something which they are afraid is the opposite of what they are supposed to be doing at the time. People with OCD can feel compelled to act in a certain way, regardless of how they are feeling or what they think they should do. Even when their behavior is completely unrelated to whatever the thoughts they are feeling at that point, they can feel obligated to carry out the irrational behavior required to get the compulsion under control." - Anonymous Online Contributor

Unverified Answer

How many people get obsessive-compulsive disorder a year in the United States?

"According to ICD-9, OCD was diagnosed in 0.5 per 1,000 people in 2002. Assuming no overlap with psychiatric disorders in ICD-9, OCD is estimated to afflict 50,500 people in the United States with OCD in 2002. That fits neatly into the number of 50,000 reported in recent literature (see Cialdini et al., 2008). As OCD is an episodic disorder with a peak frequency within the first decade, the lifetime prevalence in the US is most likely to be at least 0.4%. As there were 677,000 people hospitalized for OCD in 2001, OCD should affect 1 in 2,200 of the population." - Anonymous Online Contributor

Unverified Answer

Can obsessive-compulsive disorder be cured?

"Treatments for OCD are effective only in those with a'responder' pattern of symptom progression. Long-term treatment of OCD is probably not possible when only a small proportion of people improves. Furthermore, OCD is a very poor surrogate for 'well-being' and it is likely that'standard' psychotherapy is insufficient." - Anonymous Online Contributor

Unverified Answer

What is obsessive-compulsive disorder?

"Obsessive-compulsive disorder (OCD) is a mood disturbance characterized by obsessions (obsessions with a particular object or situation) and compulsions ( compulsion to perform certain actions repeatedly).\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for obsessive-compulsive disorder?

"There is no single treatment that is effective for treating all types of OCD. There is considerable evidence that pharmacotherapy is a valid and effective treatment for OCD in both children and adults. The most often prescribed medications to treat OCD are SSRIs and anti-depressants. Another less common line of treatment for OCD concerns the use of neuroleptic medication such as chlorpromazine and clomipramine, or neurophysiologic treatments such as electroconvulsive therapy or transcranial magnetic stimulation. There are a variety of cognitive therapies that are also effective in the treatment of OCD." - Anonymous Online Contributor

Unverified Answer

What is naproxen sodium?

"We found a high risk of extrapyramidal side effects in patients receiving naproxen, especially when combined with benzodiazepines. The authors hypothesize that naproxen causes extrapyramidal symptoms via a direct effect mediated by dopamine in the striatum, and not just by inhibition of cyclooxygenase as other NSAIDs do. Clinicians and patients should be cautious about combining naproxen and benzodiazepines." - Anonymous Online Contributor

Unverified Answer

Is naproxen sodium safe for people?

"Based on the high and sustained discontinuation rate, naproxen sodium did not appear to provide adequate risk mitigation in the long term. Further study is needed to determine the efficacy and safety of naproxen as a safer alternative to analgesics such as paracetamol and NSAIDs for people with OA." - Anonymous Online Contributor

Unverified Answer

Is naproxen sodium typically used in combination with any other treatments?

"The clinical use of naproxen sodium was not associated with increased co-medication use; the combination with non-medical drugs was not higher in patients receiving naproxen sodium than in other controls. The treatment response was similar; both groups had a small but statistically significant response. More studies are needed to confirm these results." - Anonymous Online Contributor

Unverified Answer

What is the latest research for obsessive-compulsive disorder?

"There is a relatively large and growing body of empirical research on the etiology of OCD. Many theories of OCD are currently being investigated, and future research will likely employ innovative designs to further explore some theories." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of obsessive-compulsive disorder?

"Cannabis use may play a leading role in some cases and is definitely part of the syndrome. For this condition, your doctor may suggest several treatments. The best way to overcome the symptoms of OCD is to seek psychotherapy through self-help or clinical services by qualified professionals.\n" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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