Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies (NARSAD)
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|ClinicalTrials.gov Identifier: NCT03283670|
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : April 2, 2018
Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (TRMD). New treatments for TRMD are needed, and one promising line of research are drugs known as N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD.
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.
All patients will receive 3 randomized, one hour nitrous oxide inhalations to placebo (0% N2O), low dose (25% N2O), and high dose (50% N2O). Inhalation sessions will be at least 4 weeks apart. Mood will be assessed at baseline, 2 and 24 hours, and 1, 2, and 4 weeks post-inhalation for each dose.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major Depressive Disorder, Treatment-Resistant||Drug: Nitrous Oxide 25% Drug: Nitrous Oxide 50% Drug: Placebo Gas||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
Experimental: Nitrous Oxide 25%
One hour inhalation of 25% nitrous oxide
Drug: Nitrous Oxide 25%
Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at a concentration of 25% nitrous oxide/50% oxygen/25% nitrogen.
Experimental: Nitrous Oxide 50%
One hour inhalation of 50% nitrous oxide
Drug: Nitrous Oxide 50%
Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at a concentration of 50% nitrous oxide/50% oxygen.
Placebo Comparator: Placebo Gas
One hour inhalation of placebo gas
Drug: Placebo Gas
Placebo gas given at 50% nitrogen [inert]/50% oxygen.
- Change in depression symptoms measured by the Hamilton Depression Rating Scale- 21 items [ Time Frame: 2 and 24 hours after inhalation ]Change in depression symptoms measured by the Hamilton Depression Rating Scale- 21 items
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283670
|Contact: Britt Gott, MSemail@example.com|
|Contact: Linda Barnesfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Britt Gott, MS 314-362-2463 email@example.com|
|Contact: Linda Barnes 314-747-7348|
|Principal Investigator: Peter Nagele, MD|
|Principal Investigator:||Ben Palanca, MD||Washington University School of Medicine|