Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360419
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-08
Brief Title:
Progressing TAAR-1 Dopamine and Norepinephrine in Depression Using Solriamfetol
Sponsor:
Axsome Therapeutics Inc
Organization:
Axsome Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of Solriamfetol in Subjects With Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-04
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:
PARADIGM
Brief Summary:
PARADIGM Progressing TAAR-1 Dopamine and Norepinephrine in Depression Using Solriamfetol is a Phase 3 randomized double-blind placebo-controlled multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder MDD in adults
Detailed Description:
Eligible subjects must have a primary diagnosis of MDD without psychotic features based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM-5 criteria Subjects will be randomized in a 11 ratio to receive either solriamfetol 300 mg or placebo for 6 weeks
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