Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2024-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to investigate a short-term treatment option for major depressive disorders by administering nitrous oxide gas. At this time, the main purpose is to complete a feasibility study with 40 participants suffering from treatment-resistant depression. Participants will be randomized to (1) Study group: Nitrous oxide (inhaled) + solution of saline (injected) and the (2) Control group: Oxygen (inhaled) + Midazolam (injected) as an Active Placebo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sustained Mood Improvement With Laughing Gas Exposure

NCT07262008

Major Depressive Disorder Treatment Resistant Depression

NOT_YET_RECRUITING PHASE3

SMILE Trial - Imaging Sub-Study

NCT05528718

Major Depressive Disorder

COMPLETED

Antidepressant Effects of Nitrous Oxide

NCT05357040

Major Depressive Disorder Treatment Resistant Depression

RECRUITING PHASE2

Nitrous Oxide for Major Depressive Disorder

NCT03932825

Depressive Disorder Major Depressive Disorder Treatment Resistant Depression +2 more

COMPLETED PHASE2

Nitrous Oxide for Late-Life Depression - PROTO-BRAIN

NCT05007028

Late-Life Depression Resistant Depression, Treatment

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment Resistant Depression Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nitrous Oxide + saline solution

Group Type EXPERIMENTAL

Nitrous Oxide 99 %

Intervention Type DRUG

Nitrous oxide will be administered at an inspiratory concentration of 50% with concurrent intravenous saline (100ml) for one hour.

Oxygen + Midazolam

Group Type ACTIVE_COMPARATOR

Oxygen + Midazolam

Intervention Type DRUG

Oxygen will be administered at 50% with intravenous midazolam (0.02mg/kg in 100ml) for one hour

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitrous Oxide 99 %

Nitrous oxide will be administered at an inspiratory concentration of 50% with concurrent intravenous saline (100ml) for one hour.

Intervention Type DRUG

Oxygen + Midazolam

Oxygen will be administered at 50% with intravenous midazolam (0.02mg/kg in 100ml) for one hour

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 to 65 years of age
2. Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for Major Depressive Disorder (MDD)
3. Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI) for DSM-5
4. Experiencing moderate to severe depressive episode, as defined by the Hamilton Depression Rating Scale (HAMD)\>17
5. Failure of two trials of antidepressant therapy of adequate dose and duration, during the current depressive episode
6. For women of childbearing potential, use of highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the female participant
7. Capacity to provide informed consent.

Exclusion Criteria

1. Acute suicidality defined as score ≥3 on HAMD item 3
2. Major Depressive Episode in people with Bipolar Disorder
3. Current substance abuse or dependence and/or history of alcohol abuse or dependence within the past year
4. Dementia
5. Current or lifetime history of schizophrenia or schizoaffective disorder
6. Current history of dissociative disorders
7. Known history of hypersensitivity or allergy to Nitrous Oxide, Midazolam or any ingredients in the study formulations
8. Contraindication to receiving nitrous oxide
9. Chronic cobalamin or folate deficiency
10. Contraindication to receiving the placebo midazolam
11. Use of centrally acting medicinal products, such as opioid agonists, morphine derivatives, benzodiazepines and/or other central nervous system depressants such as barbiturates and alcohol
12. Pregnancy or breastfeeding in female participants
13. Electroconvulsive therapy within the current depressive episode
14. Receiving ketamine treatment within the current depressive episode
15. Unwilling to maintain current antidepressant regimen.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No