What side effects are associated with this type of intervention?

Common treatments for OCD, such as SSRIs (e.g., fluvoxamine), memantine, D-cycloserine, celecoxib, and N-acetylcysteine, have various side effects. SSRIs can cause nausea, insomnia, and sexual dysfunction. Memantine may lead to dizziness, headache, and confusion. D-cycloserine is generally well-tolerated but can cause mild side effects like headache and dizziness. Celecoxib, an anti-inflammatory, can cause gastrointestinal issues and cardiovascular risks. N-acetylcysteine is usually well-tolerated but may cause mild gastrointestinal discomfort. Nitrous oxide, used for its anxiolytic and analgesic properties, can cause dizziness, nausea, and in rare cases, vitamin B12 deficiency with prolonged use.

What prior FDA approvals exist?

The primary FDA-approved treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, and paroxetine, as well as the tricyclic antidepressant clomipramine. These medications work by increasing serotonin levels in the brain, which helps alleviate OCD symptoms. While nitrous oxide is being studied for its rapid anxiolytic effects, it is not yet approved for OCD treatment. Other anxiolytic drugs, like benzodiazepines, are generally not used as first-line treatments for OCD due to their potential for dependence and side effects.

What other types of research exist?

Promising novel alternatives to nitrous oxide for treating OCD in 2024 include low-dose oral midazolam-ketamine combinations, which have shown efficacy in anxiolysis and sedation. Additionally, treatments like sodium oxybate and pitolisant have demonstrated effectiveness in managing symptoms of anxiety and OCD, offering potential new options for patients.

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Inhaled Anesthetic

Nitrous Oxide for Obsessive-Compulsive Disorder

Phase 2

Recruiting

Led By Peter J van Roessel, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Capacity to provide informed consent

Age 18-65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Summary

This trial uses nitrous oxide gas, commonly known as laughing gas, to see if it can quickly help people with OCD. It targets individuals with OCD because they often struggle with persistent and distressing thoughts and behaviors. The gas might work by altering brain chemicals to improve mood and reduce symptoms.

Who is the study for?

This trial is for adults aged 18-65 with a primary diagnosis of OCD who have severe symptoms. Participants must be able to give informed consent and go through a treatment-free period. It's not open to those on conflicting medications, with certain psychiatric or medical conditions, or women who are pregnant or nursing.

What is being tested?

The study is testing if inhaling nitrous oxide can quickly help improve OCD symptoms compared to inhaling nitrogen (a non-active gas). The idea is that the anesthetic properties of nitrous oxide might offer rapid relief from the distress caused by OCD.

What are the potential side effects?

While generally well-tolerated, inhaled nitrous oxide may cause side effects like dizziness, nausea, headache, fatigue, and in rare cases numbness or tingling due to its anesthetic nature.

Eligibility Criteria

Inclusion Criteria

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

Select...

I understand and can agree to the study's procedures and risks.

Select...

I am between 18 and 65 years old.

Select...

My primary diagnosis is OCD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

Side effects data

From 2018 Phase 4 trial • 63 Patients • NCT03085563

hypoxia

paradoxical reaction

100%

80%

60%

40%

20%

Study treatment Arm

Intranasal Midazolam

Nitrous Oxide

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: Nitrous OxideExperimental Treatment1 Intervention

OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.

Group II: Control: NitrogenPlacebo Group1 Intervention

OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitrous Oxide

2016

Completed Phase 4

~8380

0 / 3Eligibility 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), serotonin-norepinephrine reuptake inhibitors (SNRIs), and cognitive-behavioral therapy (CBT) with exposure and response prevention (ERP). SSRIs and SNRIs work by increasing the levels of serotonin and norepinephrine in the brain, which helps to regulate mood and reduce anxiety. 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. Nitrous oxide, currently under investigation, may offer rapid symptom relief due to its anxiolytic and analgesic properties. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage their expectations regarding the onset and type of symptom relief.

Beyond refractory obsessions and anxiety states: toward remission.[Psychosurgery and the neurosurgical treatment of pain: a systematic review of the experience gained in these kinds of treatment].