Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618118
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
A Study to Assess Adverse Events of Fosigotifator ABBV-CLS-7262 in Adults With Major Depressive Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Randomized Double-blind Placebo-Controlled Experimental Medicine Study of Fosigotifator in Adults With Major Depressive Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Major depressive disorder MDD depression is a mood disorder that causes a continued feeling of sadness and loss of interest It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness irritability not being able to focus on activities tiredness changes in eating habits and aches and pains The main goal of the study is to evaluate how safe and effective fosigotifator is in treating MDD
Fosigotifator ABBV-CLS-7262 is a new treatment being developed for adult patients with depression This study is double-blinded which means that neither the patients nor the study doctors know who is given fosigotifator and who is given placebo Participants will be randomly assigned to one of the two groups to receive fosigatofator or placebo There is 1 in 2 chance that participants will receive placebo Approximately 106 adult participants with MDD will be enrolled in approximately 15 sites across the world
Participants will receive oral fosigotifator or matching placebo Duration of the study is approximately 144 days
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular weekly visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Fosigotifator ABBV-CLS-7262 is a new treatment being developed for adult patients with depression This study is double-blinded which means that neither the patients nor the study doctors know who is given fosigotifator and who is given placebo Participants will be randomly assigned to one of the two groups to receive fosigatofator or placebo There is 1 in 2 chance that participants will receive placebo Approximately 106 adult participants with MDD will be enrolled in approximately 15 sites across the world
Participants will receive oral fosigotifator or matching placebo Duration of the study is approximately 144 days
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular weekly visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
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