Efficacy and Safety of Tildacerfont in MDD Patients
Research type
Research Study
Full title
A 15-week, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase 2 Proof-of-Concept Trial with an 8 Week Treatment Period to Study the Safety, Tolerability and Efficacy of a Fixed Dose of Tildacerfont in Outpatients with Major Depressive Disorder (MDD)
IRAS ID
1012061
Contact name
Dr Hans Eriksson
Contact email
Sponsor organisation
HMNC Holding GmbH
ISRCTN Number
ISRCTN73588250
Research summary
The purpose of this study to test the drug tildacerfont, which is being developed for the treatment of Major Depressive Disorder (MDD). MDD is a highly debilitating mental disorder, ranked as one of the leading causes of disability worldwide by the World Health Organisation. Many people do not gain sufficient benefit or suffer side-effects from current approved medications. The current antidepressant pharmaceutical therapies, including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants have several limitations. There is an unmet need for novel treatments that offer better clinical outcomes by adequately addressing the underlying biology of depression. Increasing attention is drawn to the field of precision psychiatry which aspires to provide personalised treatments for patients, after accounting for their biological variabilities. The aim is to allocate patients to treatments they are most likely to benefit from, by accurately characterising their genetics, neuronal circuits and other physiological parameters.
This study will evaluate the use of tildacerfont for depression in people with a positive CRHR1CDx result which the Sponsor believes to reflect a predisposition for altered stress regulation. 88 participants will be enrolled who will be divided into two groups, 1 group will be administered doses of tildacerfont, and 1 group will be administered a placebo. There is equal chance of getting either medication or placebo. Individuals aged 18-65 with moderate to severe depression, who are not currently taking antidepressant medication, or willing to discontinue them, will be invited to take part. Participation in the study will last 15 weeks, participants will be required to attend 8 study visits, consisting of 1 screening visit and 7 clinic visits. Participants will also be contacted by phone on 1 occasion. Study visits will take place at UK clinical research units.REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0104
Date of REC Opinion
7 May 2025
REC opinion
Further Information Favourable Opinion