Nitrous Oxide as Treatment for Major Depression - a Pilot Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression, Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT02139540

Run by

Washington University School of Medicine

People needed

21

Starts

2012-11-01

Expected to finish

2015-04-01

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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