Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285916
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-17
Brief Title:
A Study to Assess the Efficacy Safety and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression
Sponsor:
Gerbera Therapeutics Inc
Organization:
Gerbera Therapeutics Inc
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blinded Phase 2 Study to Evaluate the Efficacy Safety and Tolerability of Oral NORA520 in Female Adults With Severe Postpartum Depression
Status:
RECRUITING
Status Verified Date:
2024-07
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:
NuMom
Brief Summary:
The purpose of this research study is to test the study drug NORA520 as a possible treatment for severe postpartum depression PPD The trial aims to determine
How well NORA520 is tolerated and what side effects it may cause
If NORA520 reduces depressive symptoms in subjects with severe PPD
The amount of NORA520 in the blood at various times after taking the study drug this provides information that helps determine how often NORA520 should be taken
In a subset of subjects the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups All subjects will take the study drug for 3 days
How well NORA520 is tolerated and what side effects it may cause
If NORA520 reduces depressive symptoms in subjects with severe PPD
The amount of NORA520 in the blood at various times after taking the study drug this provides information that helps determine how often NORA520 should be taken
In a subset of subjects the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups All subjects will take the study drug for 3 days
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