Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656416
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
ALTO-100 in Bipolar Disorder with Depression BD-D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults with Bipolar Disorder Currently Experiencing a Major Depressive Episode
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 purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode when used adjunctively to a mood stabilizer related to patient characteristics Additionally safety tolerability and efficacy will be assessed in a subsequent open label treatment 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