Trial Outcomes & Findings for Nitrous Oxide for PTSD (NCT NCT04378426)
NCT ID: NCT04378426
Last Updated: 2023-03-03
Results Overview
Improvement in PTSD severity is measured by the Clinician Administered PTSD Scale DSM-5 (CAPS-5). It measures frequency and intensity of PTSD-related symptoms. For the CAPS-5 the minimum units are 0 and maximum units are 80. The higher the number on the CAPS-5, the more severe the PTSD symptoms. Response is defined as a change in the CAPS-5 of at least 12 points, which represents meaningful improvement in clinical PTSD symptoms.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
1 week
Results posted on
2023-03-03
Participant Flow
Participant milestones
| Measure |
Nitrous Oxide
PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline
Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline
Oxygen: inhaled gas
Saline: Placebo infusion
|
Midazolam
PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Oxygen: inhaled gas
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitrous Oxide for PTSD
Baseline characteristics by cohort
| Measure |
Nitrous Oxide
n=1 Participants
PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline
Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline
Oxygen: inhaled gas
Saline: Placebo infusion
|
Midazolam
PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Oxygen: inhaled gas
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 0 • n=93 Participants
|
—
|
49 years
STANDARD_DEVIATION 0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
—
|
1 participants
n=27 Participants
|
|
CAPS 5
|
64 units on a scale
STANDARD_DEVIATION 0 • n=93 Participants
|
—
|
64 units on a scale
STANDARD_DEVIATION 0 • n=27 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: The study was terminated in partnership with program officer given that the nitrous oxide administration space in the hospital (which had been used pre-pandemic) is longer available - it is being used exclusively for clinical care to keep up with the clinical backlog of cases due to the pandemic. This delay will continue for the foreseeable future. COVID-19 has had far-reaching impact on the feasibility of the study, which will not meet its recruitment goal in the foreseeable future.
Improvement in PTSD severity is measured by the Clinician Administered PTSD Scale DSM-5 (CAPS-5). It measures frequency and intensity of PTSD-related symptoms. For the CAPS-5 the minimum units are 0 and maximum units are 80. The higher the number on the CAPS-5, the more severe the PTSD symptoms. Response is defined as a change in the CAPS-5 of at least 12 points, which represents meaningful improvement in clinical PTSD symptoms.
Outcome measures
| Measure |
Nitrous Oxide
n=1 Participants
PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline
Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline
Oxygen: inhaled gas
Saline: Placebo infusion
|
Midazolam
PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Oxygen: inhaled gas
|
|---|---|---|
|
Improvement in the Severity of PTSD as Measured by the Clinician Administered PTSD Scale DSM5 (CAPS-5)
|
46 units on a scale
Standard Deviation 0
|
—
|
Adverse Events
Nitrous Oxide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nitrous Oxide
n=1 participants at risk
PTSD participants in this arm will receive and admixture of up to 50%nitrous oxide and 50% oxygen plus intravenous saline
Nitrous Oxide: PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline
Oxygen: inhaled gas
Saline: Placebo infusion
|
Midazolam
PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Midazolam: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Nitrogen: PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
Oxygen: inhaled gas
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
100.0%
1/1 • 1 week
Only 1 participant was recruited before the study was terminated.
|
—
0/0 • 1 week
Only 1 participant was recruited before the study was terminated.
|
|
Nervous system disorders
dizziness
|
100.0%
1/1 • 1 week
Only 1 participant was recruited before the study was terminated.
|
—
0/0 • 1 week
Only 1 participant was recruited before the study was terminated.
|
|
Nervous system disorders
poor coordination
|
100.0%
1/1 • 1 week
Only 1 participant was recruited before the study was terminated.
|
—
0/0 • 1 week
Only 1 participant was recruited before the study was terminated.
|
|
Nervous system disorders
poor concentration
|
100.0%
1/1 • 1 week
Only 1 participant was recruited before the study was terminated.
|
—
0/0 • 1 week
Only 1 participant was recruited before the study was terminated.
|
|
Nervous system disorders
fatigue
|
100.0%
1/1 • 1 week
Only 1 participant was recruited before the study was terminated.
|
—
0/0 • 1 week
Only 1 participant was recruited before the study was terminated.
|
|
Nervous system disorders
general malaise
|
100.0%
1/1 • 1 week
Only 1 participant was recruited before the study was terminated.
|
—
0/0 • 1 week
Only 1 participant was recruited before the study was terminated.
|
|
Nervous system disorders
tingling in toes
|
100.0%
1/1 • 1 week
Only 1 participant was recruited before the study was terminated.
|
—
0/0 • 1 week
Only 1 participant was recruited before the study was terminated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place