Trial Outcomes & Findings for Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies (NCT NCT03283670)
NCT ID: NCT03283670
Last Updated: 2022-04-04
Results Overview
Change in depression symptoms measured by the Hamilton Depression Rating Scale- 21 items. The HAMD-21 is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score as the total score on the first 17 answers. Scale: 0=absent, 4=worst level possible) the scores on the individual items are summed. Changes will be based on measurements obtained at baseline, approximately 2 hours after inhalation, and approximately 24 hours after inhalation. Changes are based on subtracti on of baseline score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
2 and 24 hours after inhalation
Results posted on
2022-04-04
Participant Flow
Participant milestones
| Measure |
Study Participants
Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
1. 25% nitrous oxide, 25% nitrogen, 25% oxygen
2. 50% nitrous oxide, 50% oxygen
3. Placebo gas: 50% nitrogen(inert), 50% oxygen
|
|---|---|
|
Placebo Gas
STARTED
|
24
|
|
Placebo Gas
COMPLETED
|
22
|
|
Placebo Gas
NOT COMPLETED
|
2
|
|
25% Nitrous Oxide
STARTED
|
24
|
|
25% Nitrous Oxide
COMPLETED
|
20
|
|
25% Nitrous Oxide
NOT COMPLETED
|
4
|
|
50% Nitrous Oxide
STARTED
|
24
|
|
50% Nitrous Oxide
COMPLETED
|
23
|
|
50% Nitrous Oxide
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Study Participants
Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
1. 25% nitrous oxide, 25% nitrogen, 25% oxygen
2. 50% nitrous oxide, 50% oxygen
3. Placebo gas: 50% nitrogen(inert), 50% oxygen
|
|---|---|
|
Placebo Gas
Withdrawal by Subject
|
2
|
|
25% Nitrous Oxide
Withdrawal by Subject
|
4
|
|
50% Nitrous Oxide
Withdrawal by Subject
|
1
|
Baseline Characteristics
Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies
Baseline characteristics by cohort
| Measure |
Study Participants
n=24 Participants
Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
1. 25% nitrous oxide, 25% nitrogen, 25% oxygen
2. 50% nitrous oxide, 50% oxygen
3. Placebo gas: 50% nitrogen(inert), 50% oxygen
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 and 24 hours after inhalationChange in depression symptoms measured by the Hamilton Depression Rating Scale- 21 items. The HAMD-21 is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score as the total score on the first 17 answers. Scale: 0=absent, 4=worst level possible) the scores on the individual items are summed. Changes will be based on measurements obtained at baseline, approximately 2 hours after inhalation, and approximately 24 hours after inhalation. Changes are based on subtracti on of baseline score.
Outcome measures
| Measure |
25% Nitrous Oxide
n=20 Participants
25% nitrous oxide, 25% nitrogen, 25% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
|
50% Nitrous Oxide
n=23 Participants
50% nitrous oxide, 50% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
|
Placebo Gas
n=22 Participants
50% nitrogen(inert), 50% oxygen. Participants will be studied for 14 visits over approximately 18 weeks. The participants will receive 1 hour-long gas inhalation mixtures at 3 different times, which are randomly assigned.
|
|---|---|---|---|
|
Change in Depression Symptoms Measured by the Hamilton Depression Rating Scale- 21 Items
2 Hours
|
-3.0 score on a scale
Standard Deviation 3.9
|
-3.8 score on a scale
Standard Deviation 4.30
|
-3.9 score on a scale
Standard Deviation 4.3
|
|
Change in Depression Symptoms Measured by the Hamilton Depression Rating Scale- 21 Items
24 Hours
|
-4.0 score on a scale
Standard Deviation 6.6
|
-5.5 score on a scale
Standard Deviation 5.8
|
-6.0 score on a scale
Standard Deviation 6.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
25% Nitrous Oxide
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
50% Nitrous Oxide
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Placebo gas: 50% nitrogen(inert), 50% oxygen
|
25% Nitrous Oxide
n=20 participants at risk
25% nitrous oxide, 25% nitrogen, 25% oxygen
|
50% Nitrous Oxide
n=23 participants at risk
50% nitrous oxide, 50% oxygen
|
|---|---|---|---|
|
Nervous system disorders
Haziness
|
0.00%
0/22 • 18 weeks
|
5.0%
1/20 • Number of events 1 • 18 weeks
|
13.0%
3/23 • Number of events 3 • 18 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
13.0%
3/23 • Number of events 3 • 18 weeks
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/22 • 18 weeks
|
5.0%
1/20 • Number of events 1 • 18 weeks
|
8.7%
2/23 • Number of events 2 • 18 weeks
|
|
Psychiatric disorders
Laughing
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
13.0%
3/23 • Number of events 3 • 18 weeks
|
|
Psychiatric disorders
Feeling disconnected
|
4.5%
1/22 • Number of events 1 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
26.1%
6/23 • Number of events 6 • 18 weeks
|
|
Nervous system disorders
Feeling high
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
13.0%
3/23 • Number of events 3 • 18 weeks
|
|
Psychiatric disorders
Memory gaps
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
4.3%
1/23 • Number of events 1 • 18 weeks
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
4.3%
1/23 • Number of events 1 • 18 weeks
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 3 • 18 weeks
|
10.0%
2/20 • Number of events 2 • 18 weeks
|
17.4%
4/23 • Number of events 4 • 18 weeks
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/22 • 18 weeks
|
5.0%
1/20 • Number of events 1 • 18 weeks
|
8.7%
2/23 • Number of events 2 • 18 weeks
|
|
Nervous system disorders
Weakness/heave
|
0.00%
0/22 • 18 weeks
|
5.0%
1/20 • Number of events 1 • 18 weeks
|
8.7%
2/23 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • 18 weeks
|
5.0%
1/20 • Number of events 1 • 18 weeks
|
21.7%
5/23 • Number of events 5 • 18 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
8.7%
2/23 • Number of events 2 • 18 weeks
|
|
Nervous system disorders
Dry Mouth
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
8.7%
2/23 • Number of events 2 • 18 weeks
|
|
Nervous system disorders
Tingling
|
0.00%
0/22 • 18 weeks
|
5.0%
1/20 • Number of events 1 • 18 weeks
|
13.0%
3/23 • Number of events 3 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
4.3%
1/23 • Number of events 1 • 18 weeks
|
|
Surgical and medical procedures
Sore throat
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
4.3%
1/23 • Number of events 1 • 18 weeks
|
|
Gastrointestinal disorders
Intestinal gas
|
0.00%
0/22 • 18 weeks
|
5.0%
1/20 • Number of events 1 • 18 weeks
|
0.00%
0/23 • 18 weeks
|
|
Infections and infestations
Common cold/strep throat
|
0.00%
0/22 • 18 weeks
|
10.0%
2/20 • Number of events 2 • 18 weeks
|
13.0%
3/23 • Number of events 3 • 18 weeks
|
|
Gastrointestinal disorders
Stomach virus
|
9.1%
2/22 • Number of events 2 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
0.00%
0/23 • 18 weeks
|
|
General disorders
Car crash (minor)
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
4.3%
1/23 • Number of events 1 • 18 weeks
|
|
Nervous system disorders
Fainting spell
|
0.00%
0/22 • 18 weeks
|
0.00%
0/20 • 18 weeks
|
4.3%
1/23 • Number of events 1 • 18 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place