Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03965858
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2019-05-21
Brief Title:
Efficacy Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
Sponsor:
Celon Pharma SA
Organization:
Celon Pharma SA
Study Overview
Official Title:
A Multicentre Double-blind Randomised Placebo - Controlled Phase II Study to Assess Efficacy Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Depression in the Course of Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine the efficacy safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression TRD in the course of Major Depressive Disorder MDD The study is to determine the efficacy and dose response of three Esketamine doses compared with placebo
Detailed Description:
This is a randomized multiple dose placebo-controlled double-blind multicentre study of Esketamine DPI inhalation powder delivered via dry powder inhaler DPI in participants with TRD in the course of MDD There are 3 study phases Screening phase a two weeks double-blind treatment phase and a 6-week follow-up phase Participants are to be randomized in 1111 ratio to receive placebo or one of the three doses of Esketamine DPI Participants from each group will receive different dosing sequences consider as a single dose corresponding to low medium high Esketamine dose or placebo Participants will undergo one cycle of treatment consisting of four doses of Esketamine DPI or placebo over 14-day period Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None