Ignite Creation Date:
2024-05-06 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02757521
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2016-04-14
Brief Title:
Nitrous TRD Bipolar Depression
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Nitrous Oxide - A Novel Therapy for Treatment-Resistant Bipolar Depression
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study sponsor ended trial due to low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures The study will last approximately 6 to 8 weeks involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week
Detailed Description:
Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures The study will last approximately 6 to 8 weeks involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week Post-treatment assessments follow each inhalation treatment and are conducted 1 week and 2 weeks following the final inhalation treatment Patients are then randomized again into the Second Stage of the study involving the same treatment and post-treatment schedule as the First Stage detailed above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None