Phase 2 Completed N=21 Randomized Quadruple-blind Treatment

Nitrous Oxide as Treatment for Major Depression - a Pilot Study

Depression · Major Depressive Disorder

Source: ClinicalTrials.gov NCT02139540 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcomePrimary: Change in Hamilton Depression Rating Scale HDRS-21 — 5.5; 2.8 score on a scale — p=<0.05

Summary

Major depressive disorder (MDD) is a global medical problem with significant shortcomings in current therapy. Chief among these is the delay between initiation of pharmacologic therapy and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has been shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and perhaps without the need for intravenous access and anesthesia personnel. Therefore, we propose conducting a pilot randomized placebo controlled double-blind crossover study in which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for a period of one hour in addition to standard medical therapy. Depression severity will be assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using the Hamilton depression rating scale.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hamilton Depression Rating Scale HDRS-21	5.5; 2.8	<0.05 sig
SECONDARY Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR	3.2; 1.0	<0.05 sig

Eligibility Criteria

Inclusion Criteria

Adults 18-65 years of age
Major depressive disorder without psychosis with as determined by structured interview using the Mini-International Neuropsychiatric Interview (MINI).

(baseline )

HDRS-21 score of >18
Good command of the English language

Exclusion Criteria

History of:

Bipolar disorder
Schizoprenia
Schizoaffective disorder
Obsessive-compulsive disorder, panic disorder
Substance abuse or dependence (except for remote substance abuse or dependence with remission at least 1 year prior to the study and except for nicotine use disorders)
Axis II diagnoses that may interfere with the patient's ability to improve on nitrous oxide
Acute medical illness that may pose subject at risk during nitrous oxide administration
Active suicidal intention (inability to contract for safety)
Active psychotic symptoms
Patients with significant pulmonary disease and/or requiring supplemental oxygen
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
Previous administration of NMDA-receptor antagonists (e.g., ketamine) within the last 3 months
Current electro-convulsive therapy treatment
Any active suicidal ideation, intention, or planning (clinical assessment of suicidality will be used)

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Data sourced from ClinicalTrials.gov (NCT02139540). 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.