Post Traumatic Stress Disorder Clinical Trial
— tN2OOfficial title:
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
NCT number | NCT03375294 |
Other study ID # | 41822 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | April 5, 2020 |
Verified date | July 2020 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)
Status | Completed |
Enrollment | 3 |
Est. completion date | April 5, 2020 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - age 18-80 - Veterans of the United States Uniformed Services - primary diagnosis of PTSD - sufficient severity of PTSD symptoms - fluency in English - capacity to provide informed consent Exclusion Criteria: - psychiatric or medical conditions that make participation unsafe - pregnant or nursing females - allergy to nitrous oxide |
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs Palo Alto | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Patients given CAPS-5 (Clinician Administered PTSD Scale for DSM-5), a 30-item structured interview that can be used to assess PTSD symptoms over the past week. For the CAPS-5 the minimum units are 0 and maximum units on the total scale are 80. The higher the number on the CAPS-5, the more severe the symptoms. Response was defined as at least a 12 point reduction on the CAPS-5 | Baseline and 1 week post inhalation |
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