Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558344
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Study to Test Different Doses of BI 1569912 in People With Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A 6-week Multi-centre Randomised Double-blind Participant and Investigator Placebo-controlled Dose-finding Trial to Evaluate the Efficacy Tolerability and Safety of Different Doses of Oral BI 1569912 in Patients With 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:
This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression
Participants are put into 4 groups randomly which means by chance Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo Placebo tablets looks like BI 1569912 but do not contain any medicine Participants take the tablets once a day for 6 weeks
Participants are in the study for about 25 months During this time they visit the study site at least 7 times At the visits doctors and their staff ask participants about their depression symptoms At the end of the study the results are compared between the groups to see whether the treatment works The doctors also regularly check the general health of participants and take note of any unwanted effects
Participants are put into 4 groups randomly which means by chance Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo Placebo tablets looks like BI 1569912 but do not contain any medicine Participants take the tablets once a day for 6 weeks
Participants are in the study for about 25 months During this time they visit the study site at least 7 times At the visits doctors and their staff ask participants about their depression symptoms At the end of the study the results are compared between the groups to see whether the treatment works The doctors also regularly check the general health of participants and take note of any unwanted effects
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