Major Depressive Disorder: Evaluation of Fosigotifator in Adults
Research type
Research Study
Full title
A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Experimental Medicine Study of Fosigotifator in Adults with Major Depressive Disorder
IRAS ID
1010923
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2024-511017-37
Clinicaltrials.gov Identifier
Research 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.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0100
Date of REC Opinion
3 Jun 2025
REC opinion
Further Information Favourable Opinion