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NCT02139540 · ClinicalTrials.gov registry record · Phase 2

Nitrous Oxide as Treatment for Major Depression - a Pilot Study

A Phase 2 study of Depression and Major Depressive Disorder, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 2
Development phase
21
Enrollment target
1
Study location

NCT02139540: Completed Phase 2 study of Depression and Major Depressive Disorder, sponsored by Washington University School of Medicine.

NCT02139540 is a Phase 2 study of Depression and Major Depressive Disorder that has completed, run by Washington University School of Medicine. The registered enrollment target is 21 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02139540, a Phase 2 study of Depression and Major Depressive Disorder, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
21 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

(21-point Hamilton Depression Rating Scale) Scoring is based on the first 17 items on the 21 point scale. Eight items are scored on a 5-point scale, ranging form 0=not present to 4= severe. Nine are scored from 0-2.

Interventions

  • DRUG Placebo
  • DRUG Nitrous Oxide

Study Locations (1)

Missouri

  • Barnes-Jewish Hospital - St Louis

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2012-11
Est. Completion 2015-04
Phase Phase 2

What the finished NCT02139540 record still lists

NCT02139540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02139540 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT02139540 about?

NCT02139540 is a clinical study titled "Nitrous Oxide as Treatment for Major Depression - a Pilot Study". 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 ...

What is the current status of trial NCT02139540?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2012-11. Estimated completion is 2015-04.

What conditions does trial NCT02139540 study?

This clinical trial studies the following conditions: Depression, Major Depressive Disorder.

What interventions are being tested in trial NCT02139540?

The interventions under investigation include: Placebo (DRUG), Nitrous Oxide (DRUG).

Who is sponsoring clinical trial NCT02139540?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02139540 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02139540's enrollment target sits among peer trials

21 607th of 679 higher than 69 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02139540, the US trial registry maintained by the National Library of Medicine. NCT02139540 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.