Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT07226661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Sponsor:
Supernus Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SPN-821 as an Adjunctive Therapy in Adults With Major Depressive Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.
Study Oversight
Has Oversight DMC:
False
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?: