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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05357040




Registration number
NCT05357040
Ethics application status
Date submitted
9/11/2021
Date registered
2/05/2022

Titles & IDs
Public title
Antidepressant Effects of Nitrous Oxide
Scientific title
Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder
Secondary ID [1] 0 0
IRB18-1856
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Treatment Resistant Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nitrous oxide gas for inhalation
Treatment: Drugs - Placebo

Active comparator: Treatment; Nitrous Oxide 50% or 25%, group - Four-weekly, 60-minute inhalation sessions of 25% or 50% nitrous oxide, randomly assigned.

Placebo comparator: Control; Oxygen-air mixture, group - Four-weekly, 60-minute inhalation sessions of an oxygen and air mixture.


Treatment: Drugs: Nitrous oxide gas for inhalation
60-minute sessions of inhaled 50% nitrous oxide in oxygen (FiO2 0.5) or 25% nitrous oxide in oxygen (FiO2 0.75), administered weekly for 4-weeks.

Administration will be under the direct supervision of a licensed practitioner who is experienced in the use and administration of the study drug, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken (MD, or CRNA); with study patient monitoring of pulse oximetry, heart rate, respiratory, non-invasive blood pressure, and end-tidal carbon dioxide.

Treatment: Drugs: Placebo
60-minute sessions of inhaled oxygen-air mixture (FiO2 ˜0.3) to be administered weekly for 4-weeks.

Administration will be under the direct supervision of a licensed practitioner who is experienced in the use and administration of the study drug, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken (MD, or CRNA); with study patient monitoring of pulse oximetry, heart rate, respiratory, non-invasive blood pressure, and end-tidal carbon dioxide.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HDRS-21 score
Timepoint [1] 0 0
Over 4-weeks from baseline
Secondary outcome [1] 0 0
Treatment response
Timepoint [1] 0 0
At 24-hours (following treatment-1)
Secondary outcome [2] 0 0
Changes in 'Profile of Mood States' scores
Timepoint [2] 0 0
Up to 1-week (following treatment-1)
Secondary outcome [3] 0 0
Sustainability of treatment response
Timepoint [3] 0 0
Over 7-weeks (length of study participation).
Secondary outcome [4] 0 0
Treatment dose response comparison
Timepoint [4] 0 0
Over 7-weeks (length of study participation)
Secondary outcome [5] 0 0
Treatment cycle compliance
Timepoint [5] 0 0
Over 4-weeks (weekly treatment sessions)
Secondary outcome [6] 0 0
Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'depression' scores
Timepoint [6] 0 0
Over 7-weeks (length of study participation) from Baseline
Secondary outcome [7] 0 0
Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'anxiety' scores
Timepoint [7] 0 0
Over 7-weeks (length of study participation) from Baseline
Secondary outcome [8] 0 0
Changes in Computerize Adaptive Testing - Mental Health (CAT-MH) 'suicide' scores
Timepoint [8] 0 0
Over 7-weeks (length of study participation) from Baseline
Secondary outcome [9] 0 0
Suicidal ideation tracking
Timepoint [9] 0 0
Over 7-weeks (length of study participation) from Baseline
Secondary outcome [10] 0 0
Visual Analog Scale (VAS)
Timepoint [10] 0 0
At Baseline (Prior to treatment-1)
Secondary outcome [11] 0 0
Treatment remission
Timepoint [11] 0 0
At 24-hours (following treatment-1)

Eligibility
Key inclusion criteria
1. Adult (=18 years, both sexes)
2. DSM-5 criteria for MDD without psychosis, as determined using a structured clinical interview [Mini International Neuropsychiatric Interview], MDD, defined by a pre-treatment score >16 on the HDRS-21 scale and meeting DSM-5 for MDD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A current or past history of bipolar disorder, schizophrenia, or schizoaffective disorder.
2. Current obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses
3. Active suicidal intention, as determined by clinical interview assessment tool (Sheehan-STS) and clinical examination
4. Active or recent (<12 months) substance use disorder; excluding nicotine
5. Administration of NMDA-antagonists (e.g., ketamine) in previous 3 months
6. Ongoing treatment with ECT
7. Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
8. Pregnancy or breastfeeding
9. Any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin B12).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois

Funding & Sponsors
Primary sponsor type
Other
Name
University of Chicago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Nagele, MD, MSc
Address 0 0
University of Chicago, Department of Anesthesia and Critical Care
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Frank Brown Jr
Address 0 0
Country 0 0
Phone 0 0
773-834-5778
Fax 0 0
Email 0 0
fbrown@dacc.uchicago.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05357040