Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633016
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder AMPLIFY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant
This is a double-blind placebo-controlled 2-arm parallel-group Phase 2 study randomized 11 ABX-002 placebo
The study will include the following stages
1 Screening Eligibility evaluation and 11 Randomization to ABX-002 vs Placebo control Baseline - Day 1 approximately 35 days
2 42-day Treatment Period
3 2-week post dose Safety Follow-up Period
This is a double-blind placebo-controlled 2-arm parallel-group Phase 2 study randomized 11 ABX-002 placebo
The study will include the following stages
1 Screening Eligibility evaluation and 11 Randomization to ABX-002 vs Placebo control Baseline - Day 1 approximately 35 days
2 42-day Treatment Period
3 2-week post dose Safety Follow-up Period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None