Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04855747
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-04-19
Brief Title:
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder MDD
Sponsor:
Relmada Therapeutics Inc
Organization:
Relmada Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Placebo- Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder The RELIANCE-II Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
RELIANCE-II
Brief Summary:
This is an outpatient 2-arm Phase 3 multicenter randomized double-blind placebo-controlled study to assess the efficacy and safety of REL-1017 once daily QD as an adjunctive treatment of Major Depressive Disorder Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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