Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT05081167
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2021-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
Sponsor:
Relmada Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2024-03
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:
TEMPORARILY_NOT_AVAILABLE
Acronym:
Reliance III
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 a monotherapy for Major Depressive Disorder.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: