Trial Outcomes & Findings for Nitrous Oxide as Treatment for Major Depression - a Pilot Study (NCT NCT02139540)
NCT ID: NCT02139540
Last Updated: 2020-01-27
Results Overview
(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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
baseline and 24 hours
Results posted on
2020-01-27
Participant Flow
21 Participants were consented, however only 20 continued.
Participant milestones
| Measure |
N2O/Placebo
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
|
Placebo/N2O
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
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitrous Oxide as Treatment for Major Depression - a Pilot Study
Baseline characteristics by cohort
| Measure |
N2O/Placebo
n=10 Participants
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
|
Placebo/N2O
n=10 Participants
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
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
48 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 hours(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.
Outcome measures
| Measure |
Nitrous Oxide
n=20 Participants
|
Placebo
n=20 Participants
Placebo: 50% nitrogen \[inert\]/50% oxygen - otherwise completely identical administration and setup
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale HDRS-21
|
5.5 score on a scale
Interval 2.5 to 8.5
|
2.8 score on a scale
Interval 0.2 to 5.8
|
SECONDARY outcome
Timeframe: baseline and 24 hours\[Quick Inventory of Depressive Symptomatology - Self Report\] 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.
Outcome measures
| Measure |
Nitrous Oxide
n=20 Participants
|
Placebo
n=20 Participants
Placebo: 50% nitrogen \[inert\]/50% oxygen - otherwise completely identical administration and setup
|
|---|---|---|
|
Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR
|
3.2 score on a scale
Interval 1.3 to 5.0
|
1.0 score on a scale
Interval 0.9 to 2.8
|
Adverse Events
Nitrous Oxide
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitrous Oxide
n=20 participants at risk
|
Placebo
n=20 participants at risk
Placebo: 50% nitrogen \[inert\]/50% oxygen - otherwise completely identical administration and setup
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
15.0%
3/20 • 2 Weeks
|
0.00%
0/20 • 2 Weeks
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • 2 Weeks
|
10.0%
2/20 • 2 Weeks
|
|
General disorders
Dizziness
|
5.0%
1/20 • 2 Weeks
|
10.0%
2/20 • 2 Weeks
|
|
Nervous system disorders
Numbness
|
10.0%
2/20 • 2 Weeks
|
0.00%
0/20 • 2 Weeks
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • 2 Weeks
|
0.00%
0/20 • 2 Weeks
|
|
Psychiatric disorders
Panic Attack
|
5.0%
1/20 • 2 Weeks
|
0.00%
0/20 • 2 Weeks
|
|
Psychiatric disorders
Claustrophobia
|
5.0%
1/20 • 2 Weeks
|
0.00%
0/20 • 2 Weeks
|
|
General disorders
Hyperventilation
|
5.0%
1/20 • 2 Weeks
|
0.00%
0/20 • 2 Weeks
|
|
Gastrointestinal disorders
Regurgitation
|
5.0%
1/20 • 2 Weeks
|
0.00%
0/20 • 2 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/20 • 2 Weeks
|
5.0%
1/20 • 2 Weeks
|
Additional Information
Principal Investigator
Washington University
Phone: 7737022544
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place