CompletedPhase IIInterventional

The purpose of the trial is to test the safety, tolerability and efficacy of the drug tildacerfont, that is being developed for the treatment of major depressive disorder

This study is looking for volunteers aged 18-65 with moderate to severe depression to test a new drug called tildacerfont. Many people with depression don't get enough help from existing medicines, or they experience side effects. This new drug aims to work differently by targeting a specific biological process related to stress. Participants will be split into two groups: one will receive tildacerfont, and the other will get a placebo (a dummy pill). The study lasts 15 weeks and involves eight clinic visits, plus one phone call. The main goal is to check if tildacerfont is safe, tolerated well, and effective in improving symptoms of depression.

At a glance

Status

Completed

Phase

Phase II

Sponsor

MAC Clinical Research

Enrolment target

Start

21 Jul 2025

Estimated completion

11 Dec 2025

Major depressive disorder (MDD)

What is this study about?

This study is about finding better treatments for an illness called Major Depressive Disorder, often shortened to MDD, which is also known as moderate to severe depression. It's a serious condition that can make daily life very difficult. While there are treatments available, like common antidepressants, they don't work for everyone, and some people experience unwanted side effects.

Because of this, doctors and scientists are looking for new ways to treat depression, focusing on understanding its underlying biology. This particular study is testing a new drug called tildacerfont. What's interesting about tildacerfont is that it's designed to help people who have a specific genetic marker (called CRHR1CDx positive). The researchers believe this marker shows a tendency for how the body handles stress, and that tildacerfont might work well for these individuals.

So, the main goal of this study is to see if tildacerfont is safe, how well people tolerate it, and if it can effectively help reduce the symptoms of depression in those with this specific biological characteristic. By focusing on this, the study hopes to move towards more personalised treatments for depression.

Key takeaways

This study is testing a new drug for moderate to severe depression.
It's for people aged 18-65 with a specific biological marker.
Participants will receive either the new drug or a dummy pill.
The study lasts 15 weeks with eight visits to a clinic.
It aims to find out if the drug is safe and effective.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for men and women between the ages of 18 and 65. You would need to have moderate to severe depression at the moment, and it should have started within the last 12 months. Also, your depression symptoms should have been present for at least two weeks before joining the study.

Crucially, you would need to have specific blood test results that show a marker called 'CRHR1CDx-positive'. This is a key part of the study, as the drug is designed to work for people with this particular finding.

If you're currently taking antidepressant medication, you would need to be willing to stop it for a certain period before the study starts. You'd also need to be able to attend all the study visits for 15 weeks.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have moderate to severe depression?
Would you be willing to stop your current antidepressant medication for a period, if needed?
Can you commit to attending 8 clinic visits over 15 weeks?
Have you had depression symptoms for at least two weeks, starting within the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for 15 weeks. During this time, you'll have eight appointments at a UK clinical research unit. These include an initial screening visit to check if you're suitable for the study, followed by seven more clinic visits. You'll also receive one phone call during the study period.

You will be split into two groups by chance: one group will receive doses of the new drug, tildacerfont, and the other group will receive a placebo, which is a dummy pill with no active medicine. You'll have an equal chance of being in either group. Neither you nor the study team will know which you are receiving, which helps to ensure the results are accurate. You'll be asked to take the study medication (or placebo) for eight weeks.

Potential risks and benefits

While there's no guarantee you'll personally benefit from taking part, you might find the close medical monitoring and study support helpful. You'll also be contributing to important research that could lead to new treatments for depression. As with all studies, there are some potential risks. You will have blood tests, which can cause discomfort, bruising, or rarely, slight irritation at the site. We will ask you to lie down to prevent feeling faint. You will also have an ECG, a safe test that checks your heart, and may cause minor skin irritation from the stickers. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

MAC Clinical Research (Liverpool)
City only
Liverpool, England
MAC Clinical Research (Blackpool)
City only
Blackpool, England
MAC Clinical Research (Glasgow)
City only
Glasgow, Scotland
MAC Clinical Research (Manchester)
City only
Manchester, England
MAC Clinical Research (Barnsley)
City only
Barnsley, England
MAC Clinical Research (Leeds)
Unverified
Leeds, England
MAC Clinical Research (Stock-on-Tees)
Unverified
Stock-on-Tees, England
MAC Clinical Research (Cannock)
Unverified
Watling Street, England

Common questions

What is tildacerfont?

Tildacerfont is a new drug being tested to treat moderate to severe depression, specifically in people with a certain biological marker.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real drug but contains no active medicine. It's used in studies to see if the drug is truly working better than no treatment.

Will I know if I'm getting the drug or a placebo?

No, you won't know, and neither will the study team. This is a common practice in research called 'double-blind' to make sure the results are fair.

How long will I be in the study?

The study participation will last for 15 weeks in total.

What does 'CRHR1CDx-positive' mean?

It's a specific biological marker that the researchers believe shows how your body handles stress, and the drug tildacerfont is designed to work for people with this marker.

How to find out more

Ross Mears

rossmears@macplc.com +44 (0)125344451 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.