What prior FDA approvals exist?

The FDA has approved several selective serotonin reuptake inhibitors (SSRIs) for the treatment of Obsessive-Compulsive Disorder (OCD), including fluoxetine, fluvoxamine, sertraline, and paroxetine. Additionally, clomipramine, a tricyclic antidepressant with strong serotonergic properties, has also been approved. These medications primarily work by increasing serotonin levels in the brain. While the trial of Naproxen Sodium aims to explore the potential of reducing inflammation through COX inhibition for treating OCD, there are currently no FDA-approved treatments for OCD that specifically target inflammation.

What other types of research exist?

Promising novel alternatives to Naproxen Sodium for treating OCD in 2024 could include: 1) Celecoxib, a COX-2 inhibitor, which has shown efficacy in reducing inflammation and has been studied as an adjunctive treatment in neuropsychiatric conditions. 2) Ketamine, which has anti-inflammatory properties and has shown rapid antidepressant effects, potentially beneficial for OCD. 3) Omega-3 fatty acids, which have anti-inflammatory effects and have shown some benefit in neuropsychiatric disorders. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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Nonsteroidal Anti-inflammatory Drug

Naproxen Sodium for OCD in PANDAS

Q: What is the mechanism of action of this treatment?

The most common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT) with exposure and response prevention (ERP). SSRIs work by increasing serotonin levels in the brain, which helps regulate mood and reduce OCD symptoms. CBT, particularly ERP, helps patients confront and reduce their obsessions and compulsions through structured exposure to anxiety-provoking stimuli and prevention of the associated compulsive behaviors. Augmentation strategies, such as adding antipsychotics or other medications, are sometimes used when patients do not fully respond to SSRIs alone. These treatments are crucial as they target the underlying neurochemical and behavioral aspects of OCD, providing relief from symptoms. In contrast, Naproxen Sodium, an anti-inflammatory drug, is being studied for its potential to reduce inflammation-related OCD symptoms, particularly in cases like Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections (PANDAS), highlighting the role of inflammation in some OCD subtypes.

Q: What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include nonsteroidal anti-inflammatory drugs (NSAIDs) like Naproxen Sodium, which can cause gastrointestinal issues such as stomach pain, heartburn, ulcers, and bleeding, as well as kidney problems and increased blood pressure. Selective Serotonin Reuptake Inhibitors (SSRIs) are also frequently used and can lead to side effects like nausea, headache, sleep disturbances, and sexual dysfunction. Combining treatments, such as adding Celecoxib to SSRIs, may enhance efficacy but also increases the risk of gastrointestinal discomfort and cardiovascular events.

Phase 4

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 6- to 15-years-old

ages 6- to 15-years-old

Must not have

Child who is acutely psychotic or suicidal

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre- to post-8 week treatment

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests Naproxen Sodium, an anti-inflammatory drug, to see if it can reduce OCD symptoms in children with PANDAS. These children have OCD symptoms linked to inflammation from streptococcal infections. The medication aims to lower inflammation, potentially easing their symptoms.

Who is the study for?

This trial is for children aged 6-15 with PANDAS-related OCD, showing severe symptoms like anxiety, emotional changes, learning difficulties, sleep disorders, and motoric dysfunction. They must have had a recent strep infection and not be on certain medications or treatments.

What is being tested?

The study tests Naproxen Sodium against a placebo in kids with PANDAS to see if it reduces inflammation-related OCD symptoms. It's a double-blind trial meaning neither the participants nor the researchers know who gets the real medicine or placebo.

What are the potential side effects?

Naproxen may cause digestive issues like ulcers, liver or kidney problems, bleeding disorders, asthma exacerbation and could affect fluid balance. Not all children will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 15 years old.

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I am between 6 and 15 years old.

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I have noticed changes in my handwriting or involuntary movements.

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I have OCD with increased anxiety, mood swings, learning issues, regression, sleep problems, handwriting changes, and urinary issues.

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I have noticed changes in my handwriting or involuntary movements.

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My symptoms started before puberty.

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I can take medication in pill form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child is currently experiencing severe mental health issues.

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I do not have liver, kidney, or bleeding disorders.

Select...

I have had ulcers in my digestive system before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre- to post-8 week treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre- to post-8 week treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- to post-8 week treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)

Children's Yale-Brown Obsessive-Compulsive Scale, 2nd Edition (CY-BOCS-II)

Secondary study objectives

Changes in C reactive protein pre- and post-treatment between groups

Changes in erythrocyte sedimentation rate pre- and post-treatment between groups

Side effects data

From 2012 Phase 4 trial • 40 Patients • NCT01300546

Cough

Root Canal Pain

Stiffness in neck

Sinusitis

Allergic Rhinitis

Allodynia

Diarrhea

Nasal Congestion

Fever

Insomnia

Weight Gain

100%

80%

60%

40%

20%

Study treatment Arm

Sumatriptan/Naproxen Sodium

Naproxen Sodium

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Participants receive Naproxen Sodium.

Group II: PlaceboPlacebo Group1 Intervention

Participants receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naproxen Sodium

2006

Completed Phase 4

~850

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT) with exposure and response prevention (ERP). SSRIs work by increasing serotonin levels in the brain, which helps regulate mood and reduce OCD symptoms. CBT, particularly ERP, helps patients confront and reduce their obsessions and compulsions through structured exposure to anxiety-provoking stimuli and prevention of the associated compulsive behaviors. Augmentation strategies, such as adding antipsychotics or other medications, are sometimes used when patients do not fully respond to SSRIs alone. These treatments are crucial as they target the underlying neurochemical and behavioral aspects of OCD, providing relief from symptoms. In contrast, Naproxen Sodium, an anti-inflammatory drug, is being studied for its potential to reduce inflammation-related OCD symptoms, particularly in cases like Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections (PANDAS), highlighting the role of inflammation in some OCD subtypes.

d-cycloserine addition to exposure sessions in the treatment of patients with obsessive-compulsive disorder.