Phase 2 Completed N=24 Randomized Double-blind Treatment

Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies

Depressive Disorder, Major · Depressive Disorder, Treatment-Resistant

Source: ClinicalTrials.gov NCT03283670 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2022

Primary outcomePrimary: Change in Depression Symptoms Measured by the Hamilton Depression Rating Scale- 21 Items — -3.0; -3.8; -3.9; -4.0 score on a scale — p=0.55

Summary

The purpose of the study aims to determine whether different concentrations of nitrous oxide (N2O) have different antidepressant effects for adults with treatment-resistant major depression.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Depression Symptoms Measured by the Hamilton Depression Rating Scale- 21 Items	-3.0; -3.8; -3.9; -4.0; -5.5; -6.0	0.55

Eligibility Criteria

Inclusion Criteria

Adults 18-75 years of age;
Current diagnosis of unipolar major depressive disorder (MDD) without psychosis as confirmed by structured clinical interview for DSM-IV disorders;
A score of >= 9 on the Montgomery-Åsberg Depression Rating Scale (MADRS);
Documented (i.e., chart review) lifetime failure to respond to >=3 adequate dose/duration antidepressant treatment trials, ≥1 medication failure in the current depressive episode;
Good command of the English language.

Exclusion Criteria

Meets criteria for any DSM-IV diagnosis for schizophrenia, bipolar, schizoaffective, obsessive-compulsive, personality, or panic disorders;
Any recent (within past 12 months) history of substance dependence or abuse (except tobacco), determined by reported history or urine drug screen;
Ability to become pregnant and not using effective contraception;
Contraindication against the use of nitrous oxide:
Pneumothorax
Bowel obstruction
Middle ear occlusion
Elevated intracranial pressure
Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12
Pregnant patients
Breastfeeding women
Inability to provide informed consent;
Any other factor that in the investigators' judgment may affect patient safety or compliance

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03283670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.