Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT07284667
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Sponsor:
ACADIA Pharmaceuticals Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Status:
RECRUITING
Status Verified Date:
2025-12
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:
NORLIGHT
Brief Summary:
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).
The main questions the study aims to answer are:
* Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?
* What adverse events do participants have when taking ACP-211?
The main questions the study aims to answer are:
* Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?
* What adverse events do participants have when taking ACP-211?
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?: