Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058039
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-09-21
Brief Title:
Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder
Sponsor:
Neumora Therapeutics Inc
Organization:
Neumora Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-09
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 randomized double-blind placebo-controlled multicenter study will evaluate the effects of NMRA-335140 formerly BTRX-335140 on symptoms of depression in participants with Major Depressive Disorder MDD The study design consists of a Screening Period up to 35 days and a 6-week Treatment Period during which participants will receive either NMRA-335140 or placebo At the completion of the 6-week Treatment Period participants who complete the study provide informed consent and meet the eligibility criteria may enter an open-label extension study NMRA-335140-501
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KOASTAL-3 | OTHER | Neumora Therapeutics | None |