Nitrous Oxide for Major Depressive Disorder
NCT03932825, Phase 2, Completed, Lingjiang Li
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Nitrous Oxide for Major Depressive Disorder | ClinicalTrials.gov |
| NCT number | NCT03932825 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 44 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Lingjiang Li | ClinicalTrials.gov |
| Conditions | Depressive Disorder, Major Depressive Disorder, Treatment Resistant Depression, Depressive Disorder, Major, Depression | ClinicalTrials.gov |
| Interventions | Nitrous Oxide, Placebo | ClinicalTrials.gov |
| First posted | 2019-05-01 | ClinicalTrials.gov |
| Last updated | 2021-04-08 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale-17 item (HDRS-17) | Baseline, 2hours, 24hours, 7days, 2weeks | Interview-based questionnaire used to measure the severity of depression. Consists of 17 items with a score calculated. Higher scores are associated with more severe depression. 0 - 7 = Normal; 8 - 17 = Mild Depression; 18 - 24 = Moderate Depression; \> 25 = Severe Depression; Maximum score = 52 | ClinicalTrials.gov |
| Primary | Change in QIDS-16-SR (Quick Inventory of Depressive Symptomatology-16 Self Report) | Baseline, 2hours, 24hours, 7days, 2weeks | This is a 16-item self report questionnaire that measures depressive symptoms. Improvement is reported in change in depressive score score ranges from 0-27, with higher numbers indicating more severe symptom reporting. Change is calculated by baseline plus/minus the value at the later time point | ClinicalTrials.gov |
| Primary | Change in Visual Analog Scale-Depression (VAS-D) | Baseline, 2hours, 24hours, 7days, 2weeks | All patients are asked to fill out visual analog scale for depression (VAS-D) before and after the intervention. VAS-D is a self-report scale for ddepression severity, with 0 score indicating not at all depressed and 10 score indicating extremely depressed. | ClinicalTrials.gov |
| Secondary | Chang in Event Related Potentials (ERPs) | Baseline, 24hours, 7days, 2weeks | The investigator employ 64-lead Event Related Potentials (ERPs) to assess the resting-state EEG signal and signals during specific neurocognitive processes related to tasks, including an emotional face recognition task, a dot probe task and a self-referential personality word memory task. | ClinicalTrials.gov |
| Secondary | Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging. | Baseline, 24hours | Participants will receive resting-state functional magnetic resonance imaging (MRI). Scans will be performed on a 3.0-T Siemens Magnetom Skyra scanner (Siemens Healthineers, Erlangen, Germany). During scanning, all participants were instructed to remain motionless, and to think of nothing in particular but to not fall asleep. | ClinicalTrials.gov |
| Secondary | Change in Functional connectivity | Baseline, 24hours | Change in Functional connectivity of the brain networks between baseline and after the inhaled Nitrous oxide 24hours as assessed by measure of connectivity in multimodal MRI. | ClinicalTrials.gov |
| Secondary | Change in peripheral blood cytokines | Baseline, 2hours, 24hours | Peripheral blood sample will be collected and the concentration of IL-6, TNF-α, and CRP will be assessed. | ClinicalTrials.gov |
| Secondary | Change in feces bacterial flora | Baseline | The objective of investigator is to characterize gut microbiome in patients with TRD. To explore the specific diversity of gut microbiome. The stool samples were collected in the collection kits at the baseline, and were frozen at -80 °C. After the process of DNA Purification, 16S rRNA Gene Amplification and Illumina MiSeq sequencing, the study finally find the abundance and diversity of microbiota. | ClinicalTrials.gov |
| Secondary | Change in the TMT/A and B (Executive Function) | Baseline, 24hours, 7days, 2weeks | Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed. | ClinicalTrials.gov |
| Secondary | Change in Congruent STROOP Time to Complete (Executive Function) | Baseline, 24hours, 7days, 2weeks | Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility. | ClinicalTrials.gov |
| Secondary | Digit-Span Test | Baseline, 24hours, 7days, 2weeks | Score range 0-12 for each of for dimensions: Digit span forward, digit span backward, block span forward, block span backward. Higher scores indicate better cognitive performance. | ClinicalTrials.gov |
| Secondary | Change in DSST (Number of Correct Symbols) | Baseline, 24hours, 7days, 2weeks | Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST. | ClinicalTrials.gov |
| Secondary | Improvement on Snaith-Hamilton Pleasure Scale (SHAPS) | Baseline, 2hours, 24hours, 7days, 2weeks | The Snaith-Hamilton Pleasure Scale (SHAPS) assesses the anhedonia symptoms of MDD patients, with higher score indicating more severe anhedonia. Evaluating the patient's pleasure experience and choosing the degree of agreement with the happy response in some pleasant situations, and each item was rated on a 4-point scale."1 = Strongly agree, 2 = agree, 3 = disagree and 4 = strongly disagree" This scale evaluates the status of patients in the recent period of time, The total score of the scale is the sum of the scores of 14 items, with a total score of 14-56. The higher the total score, the more serious the anhedonia. | ClinicalTrials.gov |
| Secondary | Change in Hamilton Anxiety Rating Scale (HAM-A) | Baseline, 2hours, 24hours, 7days, 2weeks | Assessed via the Hamilton Anxiety Rating Scale (HAM-A). The HAM-A score ranges from 0 (no present anxiety) to 56 (maximum anxiety score). | ClinicalTrials.gov |
| Other | Change in Heart Rate Variability | Baseline, 2hours, 24hours, 7days, 2weeks | The investigator will assess the heart rate variability (HRV) of all participants before and after the intervention. | ClinicalTrials.gov |
| Other | Number of Participants With Adverse Events AEs | Baseline, 2hours, 24hours, 7days, 2weeks | AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. | ClinicalTrials.gov |
| Other | Clinician-Administered Dissociative States Scale (CADSS) Scores During inhaled nitrous oxide | Baseline, 2hours, 24hours | The CADSS is a 23-item self-report scale for the assessment of dissociative states. It is a reliable, valid self-report instrument. The severity of each dissociative symptom ranges from 0 (not present) to 4 (extreme). The total score is calculated by summing across items, with a total possible range of 0-92. The CADSS was administered right before inhaled, and 2hours and 24hours after the inhaled. The timeframe is "at this moment". Change From Baseline in Clinician-Administered Dissociative States Scale (CADSS) Score. | ClinicalTrials.gov |
| Other | Suicidal ideation as assessed by the Scale for Suicide Ideation (SSI) | Baseline, 2hours, 24hours, 7days, 2weeks | The scale contains 19 items rated on a scale from 0 to 2, allowing score range from 0 to 38, score over 4 (first five items) will be considered inclusion criteria. Higher values indicate worsening or presence of suicidal ideation. Item 4 and 5 at the end of the last week was assessed. If the answer to both questions was "no", the patient was judged to have no suicidal ideation.If either answer is "weak" or "moderate to strong," it is considered suicidal ideation.The intensity of suicidal ideation was judged according to the mean value of items 1-5 in the scale. The higher the score, the greater the intensity of suicidal ideation.The risk of suicide was assessed according to items 6-19 of the suicide ideation scale.The total score was calculated by \[(the sum of item 6-19 scores -9)/33\]\*100. The higher the score, the greater the risk of suicide. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Dot-Probe Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)