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Nitrous Oxide as Treatment for Major Depression - a Pilot Study

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ClinicalTrials.gov Identifier: NCT02139540
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Major Depressive Disorder
Interventions Drug: Nitrous Oxide
Drug: Placebo
Enrollment 21
Recruitment Details 21 Participants were consented, however only 20 continued.
Pre-assignment Details  
Arm/Group Title N2O/Placebo Placebo/N2O
Hide Arm/Group Description

First session: Nitrous oxide Second session: placebo

Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.

Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup

First session: Placebo Second session: Nitrous Oxide

Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.

Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
Period Title: Overall Study
Started 11 10
Completed 10 10
Not Completed 1 0
Arm/Group Title N2O/Placebo Placebo/N2O Total
Hide Arm/Group Description

First session: Nitrous oxide Second session: placebo

Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.

Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup

First session: Placebo Second session: Nitrous Oxide

Nitrous Oxide: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart.

Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup

 Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
48
(30 to 55)
48
(30 to 55)
48
(30 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
7
  70.0%
5
  50.0%
12
  60.0%
Male
3
  30.0%
5
  50.0%
8
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
11 10 21
1.Primary Outcome
Title Change in Hamilton Depression Rating Scale HDRS-21
Hide Description (21-point Hamilton Depression Rating Scale) Scoring is based on the first 17 items on the 21 point scale. Eight items are scored on a 5-point scale, ranging form 0=not present to 4= severe. Nine are scored from 0-2.
Time Frame baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nitrous Oxide Placebo
Hide Arm/Group Description:
[Not Specified]
Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
5.5
(2.5 to 8.5)
2.8
(0.2 to 5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nitrous Oxide, Placebo
Comments The primary outcome (HDRS-21) was analyzed with a repeated-measures mixed effects linear model using restricted maximum likelihood estimation. To adjust for the observed carryover effect, the model included a randomization group term and a three-way interaction (treatment × time × randomization group)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR
Hide Description [Quick Inventory of Depressive Symptomatology - Self Report] An item-by-item severity scale of 0 to 3, with possible total scores ranging from 0 to 84. The items on the scale are added together for a total score. Higher scores mean worse outcome.
Time Frame baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nitrous Oxide Placebo
Hide Arm/Group Description:
[Not Specified]
Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
3.2
(1.3 to 5.0)
1.0
(0.9 to 2.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nitrous Oxide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 2 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nitrous Oxide Placebo
Hide Arm/Group Description [Not Specified] Placebo: 50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
All-Cause Mortality
Nitrous Oxide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Nitrous Oxide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nitrous Oxide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/20 (70.00%)   5/20 (25.00%) 
Gastrointestinal disorders     
Nausea and Vomiting †  3/20 (15.00%)  0/20 (0.00%) 
Regurgitation †  1/20 (5.00%)  0/20 (0.00%) 
General disorders     
Dizziness †  1/20 (5.00%)  2/20 (10.00%) 
Hyperventilation †  1/20 (5.00%)  0/20 (0.00%) 
Nervous system disorders     
Headache †  2/20 (10.00%)  2/20 (10.00%) 
Numbness †  2/20 (10.00%)  0/20 (0.00%) 
Psychiatric disorders     
Anxiety †  2/20 (10.00%)  0/20 (0.00%) 
Panic Attack †  1/20 (5.00%)  0/20 (0.00%) 
Claustrophobia †  1/20 (5.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Hypercapnia †  0/20 (0.00%)  1/20 (5.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: Washington University
Phone: 7737022544
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02139540    
Other Study ID Numbers: 201204023
First Submitted: May 13, 2014
First Posted: May 15, 2014
Results First Submitted: April 23, 2018
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020