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| Name | Class |
|---|---|
| Brain & Behavior Research Foundation | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. 25% nitrous oxide, 25% nitrogen, 25% oxygen | Experimental | Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned. |
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| 2. 50% nitrous oxide, 50% oxygen | Experimental | Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned. |
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| 3. Placebo gas: 50% nitrogen(inert), 50% oxygen | Placebo Comparator | Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide 25% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Symptoms Measured by the Hamilton Depression Rating Scale- 21 Items | Change in depression symptoms measured by the Hamilton Depression Rating Scale- 21 items. The HAMD-21 is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score as the total score on the first 17 answers. Scale: 0=absent, 4=worst level possible) the scores on the individual items are summed. Changes will be based on measurements obtained at baseline, approximately 2 hours after inhalation, and approximately 24 hours after inhalation. Changes are based on subtracti on of baseline score. | 2 and 24 hours after inhalation |
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Inclusion Criteria
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:
Inability to provide informed consent;
Any other factor that in the investigators' judgment may affect patient safety or compliance
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| Name | Affiliation | Role |
|---|---|---|
| Ben Palanca, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37585253 | Derived | de Leon VC, Kumar A, Nagele P, Palanca BJ, Gott B, Janski A, Zorumski CF, Conway CR. Nitrous Oxide Reduced Suicidal Ideation in Treatment-Resistant Major Depression in Exploratory Analysis. J Clin Psychiatry. 2023 Aug 16;84(5):22br14725. doi: 10.4088/JCP.22br14725. No abstract available. |
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There is no plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Gas |
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| ||||||||||||||||||
| 25% Nitrous Oxide |
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| 50% Nitrous Oxide |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Depression Symptoms Measured by the Hamilton Depression Rating Scale- 21 Items | Change in depression symptoms measured by the Hamilton Depression Rating Scale- 21 items. The HAMD-21 is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score as the total score on the first 17 answers. Scale: 0=absent, 4=worst level possible) the scores on the individual items are summed. Changes will be based on measurements obtained at baseline, approximately 2 hours after inhalation, and approximately 24 hours after inhalation. Changes are based on subtracti on of baseline score. | Posted | Mean | Standard Deviation | score on a scale | 2 and 24 hours after inhalation |
|
18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo gas: 50% nitrogen(inert), 50% oxygen | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ben Palanca, MD PhD | Washington University | 314 273-9076 | palancab@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2019 | Feb 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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Each participant receives the 3 inhalation types in randomized, one hour sessions separated by at least 4 weeks
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|
|
| Nitrous Oxide 50% | Drug | 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 Gas | Drug | Placebo gas given at 50% nitrogen [inert]/50% oxygen. |
|
|
|
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 50% Nitrous Oxide | 50% nitrous oxide, 50% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned. |
| OG002 | Placebo Gas | 50% nitrogen(inert), 50% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned. |
|
|
|
| 22 |
| 0 |
| 22 |
| 5 |
| 22 |
| EG001 | 25% Nitrous Oxide | 25% nitrous oxide, 25% nitrogen, 25% oxygen | 0 | 20 | 0 | 20 | 8 | 20 |
| EG002 | 50% Nitrous Oxide | 50% nitrous oxide, 50% oxygen | 0 | 23 | 0 | 23 | 14 | 23 |
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Laughing | Psychiatric disorders | Systematic Assessment |
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| Feeling disconnected | Psychiatric disorders | Systematic Assessment |
|
| Feeling high | Nervous system disorders | Systematic Assessment |
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| Memory gaps | Psychiatric disorders | Systematic Assessment |
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| Paranoia | Psychiatric disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Sleepiness | Nervous system disorders | Systematic Assessment |
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| Weakness/heave | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Nervous system disorders | Systematic Assessment |
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| Tingling | Nervous system disorders | Systematic Assessment |
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| Cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sore throat | Surgical and medical procedures | Systematic Assessment |
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| Intestinal gas | Gastrointestinal disorders | Systematic Assessment |
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| Common cold/strep throat | Infections and infestations | Systematic Assessment |
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| Stomach virus | Gastrointestinal disorders | Systematic Assessment |
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| Car crash (minor) | General disorders | Systematic Assessment |
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| Fainting spell | Nervous system disorders | Systematic Assessment |
|
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| D001519 |
| Behavior |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |