RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression

This research study, called a clinical trial, is investigating a new treatment named DT-101 for adults living with depression. The main aim is to understand if DT-101 can effectively help improve symptoms of depression and if it's safe to use. To do this, some participants will receive DT-101, while others will receive a placebo – a pill that looks the same but contains no active medicine. Throughout the study, participants will have regular check-ups, including physical examinations and questionnaires, to monitor their health and how their depression symptoms change. This helps the researchers compare the effects of DT-101 with the placebo.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Draig Therapeutics Ltd

Enrolment target

300

Start

16 Dec 2025

Estimated completion

01 Aug 2027

Major Depressive Disorder (MDD)

What is this study about?

This study is about a new treatment called DT-101 for people who have depression. When we talk about depression in this study, we mean "Major Depressive Disorder," which is a type of depression that can affect many parts of a person's life. Researchers want to find out if DT-101 can make a real difference in how people feel and if it's a safe option.

To see if DT-101 works, some people in the study will get the new medication, and others will get something called a 'placebo.' A placebo looks just like the real medicine but doesn't have any active ingredients. This helps researchers compare the effects fairly, so they can tell if any changes are due to DT-101 or to other factors. This is a common and important way to test new medicines.

They also want to understand how your body handles DT-101. This includes checking how the medicine is absorbed and used. Sometimes, they might also look at genetic information from blood samples to see if your genes might affect how well DT-101 works for you. This kind of research helps them learn more about who might benefit most from the treatment in the future.

Key takeaways

This study tests a new depression medication called DT-101.
It aims to see if DT-101 works better than a dummy pill (placebo).
Participation involves regular clinic visits for health checks and surveys.
You must be an adult with a history of depression to qualify.
Your health will be closely monitored throughout the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be an adult between 18 and 75 years old. You need to be able to read and understand information given to you in English, and be willing to give your written permission to take part. Importantly, you must have been diagnosed with a type of depression called Major Depressive Disorder, and have had at least one previous episode of depression besides your current one.

There are also some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant during the study, you cannot take part. Also, if you have certain other serious health problems, such as an unstable long-term illness, specific nerve (neurological) issues, or a history of seizures, this study might not be right for you. If you've had significant issues with alcohol or drug use in the past six months, you also wouldn't be able to join.

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 75 years old?
Do you have a diagnosis of Major Depressive Disorder?
Have you had at least one previous episode of depression?
Are you NOT pregnant or breastfeeding, and not planning to be?
Do you NOT have an unstable long-term health condition or a history of seizures?
Have you NOT had significant issues with alcohol or drug use in the past 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will need to come to the clinic regularly, usually every couple of weeks. During these visits, the study team will do general health checks, which might include a physical examination, checking your nerve responses, and taking blood and urine samples. You will also be asked to complete questionnaires about how you are feeling and your depression symptoms. These tests help the researchers understand how you are responding to the medication and to make sure you are safe to continue.

You will be given either the new study medication, DT-101, or a placebo (a dummy pill). You won't know which one you are receiving. The study team will continue to take blood samples throughout the study to see how the medication is absorbed and used by your body. Some of these blood samples might also be stored for future research to look at how your genes might affect your response to the treatment. The total duration of your participation will be explained to you by the study team.

Potential risks and benefits

Taking part in a study like this means you might be among the first to receive a new treatment for depression, which could potentially improve your symptoms. However, DT-101 is still being tested, so there's no guarantee it will work for you, and like all medications, it could have side effects. These risks and potential benefits will be fully explained to you before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

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

Draig Clinical Site
Verified postcode
Bentonville, United States· Recruiting
Draig Clinical Site
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Little Rock, United States· Recruiting
Draig Clinical Site
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Oceanside, United States· Recruiting
Draig Clinical Site
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San Diego, United States· Recruiting
Draig Clinical Site
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Torrance, United States· Recruiting
Draig Clinical Site
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Miami, United States· Recruiting
Draig Clinical Site
Verified postcode
New Port Richey, United States· Recruiting
Draig Clinical Site
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Orlando, United States· Recruiting
Draig Clinical Site
Verified postcode
Atlanta, United States· Recruiting
Draig Clinical Site
Verified postcode
Decatur, United States· Recruiting
Draig Clinical Site
Verified postcode
Gaithersburg, United States· Recruiting
Draig Clinical Site
Verified postcode
Watertown, United States· Recruiting

Common questions

What is a 'placebo'?

A placebo is a 'dummy pill' that looks exactly like the study medication but doesn't contain any active medicine. It helps researchers compare the new drug's effects fairly.

Will I know if I'm getting DT-101 or the placebo?

No, neither you nor the study team will know whether you are receiving DT-101 or the placebo during the study. This is standard practice in clinical trials to ensure fair results.

How often will I need to visit the clinic?

You will need to visit the clinic regularly, usually every couple of weeks, for health checks and to complete questionnaires.

What kind of tests will I have?

You will have general health checks, physical exams, and blood and urine tests. You'll also fill out questionnaires about how you're feeling.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Chief Medical Officer

info@draigtherapeutics.com +44(0)2920028450 Official trial record

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