Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06011577
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-08-21
Brief Title:
Randomized Double-Blind Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
Sponsor:
Relmada Therapeutics Inc
Organization:
Relmada Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder RELIGHT
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT06009003
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
RELIGHT
Brief Summary:
A Phase 3 randomized double-blind placebo-controlled multicenter trial of REL-1017 in patients with major depressive disorder MDD
Detailed Description:
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 in patients with inadequate response to ongoing background antidepressant treatment Eligible patients will continue to take their background antidepressant therapy and be randomized in a 11 ratio to treatment with REL-1017 or placebo for a 4 week treatment period
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