Sustained Mood Improvement With Laughing Gas Exposure

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWomen's College Hospital

About this trial

Multi-centre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of nitrous oxide on reducing symptoms of depression in patients with treatment resistant depression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 65 years of age

Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for Major Depressive Disorder (MDD)

Current major depressive episode as confirmed by the Mini International Neuropsychiatric Interview (MINI) for DSM-5

Experiencing moderate to severe depressive episodes, as defined by the Montgomery-Åsberg Depression Rating Scale (MADRS) > 21

Disqualifiers

Acute suicidality defined as score > 4 on MADRS item 10

Diagnosis of Bipolar Disorder

Current substance abuse or dependence and/or history of alcohol abuse or dependence within the past year

Dementia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inhalation of Nitrous oxide (Laughing gas) + intravenous saline

    Drug

    Nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (20ml) for one hour.

  • inhalation of %100 oxygen + intravenous midazolam

    Drug

    Inspiration of 100% oxygen with concurrent intravenous midazolam (0.02mg/kg, up to 2 mg) for one hour.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Active Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

The MADRS is a 10-item clinician-rated scale used to assess the severity of depressive symptoms and to detect changes over time in response to treatment. It is commonly used in randomized controlled trials due to its sensitivity to change and strong psychometric properties. The MADRS is also recognized by regulatory and health technology assessment agencies, including the U.S. Food and Drug Administration (FDA) and the Canadian Agency for Drugs and Technologies in Health (CADTH), as an established measure for evaluating treatment efficacy in depression. Higher scores indicate worse outcomes and greater severity of depression.

Time frame
Baseline to the 2-week follow-up (Visit 6 - Day 35).

Secondary outcomes

1

Proportion of patients who achieved a response

Defined as a 50% reduction in MADRS score between baseline and the 2- and 12-week follow-ups.

Time frame
2-week and 12-week follow-ups post last intervention visit
2

Proportion of patients who achieved remission

Defined as achieving both a response and a MADRS score \<10 at the 2- and 12-week follow-ups.

Time frame
2-week and 12-week follow-ups post last intervention visit
3

Change in self-reported depressive symptoms

Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR-16) Higher scores are associated with increased severity in depressive symptoms Total scores range from 0-27 Normal/No Depression 0-5 Mild Depression 6-10 Moderate Depression 11-15 Severe Depression 16-20 Very Severe Depression 21-27

Time frame
2-week and 12-week follow-ups post last intervention visit
4

Change in cognitive function

Assessed using the Digit Symbol Substitution Test (DSST) The Digit Symbol Substitution Test (DSST) measures processing speed, attention, and executive function by assessing a person's ability to quickly and accurately pair numbers with symbols according to a key. To score it, the total number of correct symbol-for-number substitutions completed within a timed period (typically 90-120 seconds) is counted. Higher scores indicate better performance.

Time frame
2-week and 12-week follow-ups post last intervention visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's College Hospital

Lead sponsor

Anesthesia Clinical Trials Unit (Department of Anesthesia and Pain Management)

Collaborator

University Health Network, Toronto

Collaborator

Sunnybrook Health Sciences Centre

Collaborator

Unity Health Toronto

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: