Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03869736




Registration number
NCT03869736
Ethics application status
Date submitted
16/12/2018
Date registered
11/03/2019

Titles & IDs
Public title
Nitrous Oxide for the Treatment of Major Depressive Disorder
Scientific title
Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder
Secondary ID [1] 0 0
438/19
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Major Depressive Disorder 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
Treatment: Drugs - Placebo

Experimental: Nitrous Oxide 50% or 25% - Nitrous oxide at an inhaled concentration of 50% or 25%

Sham comparator: Placebo - Oxygen-air mixture


Treatment: Drugs: Nitrous Oxide
1-hour sessions of inhaled nitrous oxide at concentrations of 25% or 50% (randomly assigned) to be administered weekly for 4 weeks.

Treatment: Drugs: Placebo
1-hour sessions of inhaled oxygen-air mixture (inspired oxygen concentration \~23-30%) to be administered weekly for 4 weeks.
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 and remission
Timepoint [1] 0 0
at 24 hours
Secondary outcome [2] 0 0
Pattern of treatment response
Timepoint [2] 0 0
Up to 1 week after treatment
Secondary outcome [3] 0 0
Sustainability of treatment response - change in HDRS-21 scores
Timepoint [3] 0 0
over 7 weeks
Secondary outcome [4] 0 0
Sustainability of treatment response - response and remission rates
Timepoint [4] 0 0
over 7 weeks
Secondary outcome [5] 0 0
Treatment compliance rate
Timepoint [5] 0 0
over 4 weeks
Secondary outcome [6] 0 0
Dose effect of nitrous oxide using treatment-by-dose interaction term in a logistic regression model
Timepoint [6] 0 0
over 7 weeks
Secondary outcome [7] 0 0
Computerized Adaptive Test-Depression Inventory (CAT-DI)
Timepoint [7] 0 0
over 7 weeks
Secondary outcome [8] 0 0
Computerized Adaptive Test-Suicide Scale (CAT-SS)
Timepoint [8] 0 0
over 7 weeks

Eligibility
Key inclusion criteria
1. Adult (=18 years, both sexes), with DSM-IV-TR criteria for MDD without psychosis, as determined using a structured clinical interview [Mini International Neuropsychiatric Interview]
2. MDD, as defined by a pretreatment score >18 on the HDRS-21 scale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
2. Active or recent (<12 months) substance abuse or dependence; excluding nicotine
3. Administration of NMDA-antagonists (e.g., ketamine) in previous 3 months
4. Ongoing treatment with ECT
5. Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
6. Pregnancy or breastfeeding
7. 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/12/2023
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
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
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Paul Myles, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carolyn Deng, MBChB
Address 0 0
Country 0 0
Phone 0 0
+61399030760
Fax 0 0
Email 0 0
c.deng@alfred.org.au
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/NCT03869736