Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Effects of DLX-001 on PD, Safety, Tolerability, and PK in Participants with MDD

This research study is investigating a new medicine called DLX-001 for adults who have major depressive disorder, which is a type of depression that can significantly affect daily life. This is a very early stage (Phase 1) study, which means the main goals are to understand if DLX-001 is safe for people, how well their bodies tolerate it, and how the medicine moves through and is cleared from the body. We call this 'pharmacokinetics'. By carefully studying these aspects, researchers can determine if it's safe to continue testing DLX-001 in larger studies to see if it can help improve symptoms of depression. This type of research is crucial for developing potential new ways to treat depression in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Delix Therapeutics Inc., Delix Therapeutics Inc.

Enrolment target

Start

04 Nov 2024

Major Depressive Disorder (MDD)

What is this study about?

This study is about a new medicine, or 'intervention,' called DLX-001. It's being tested in people who have Major Depressive Disorder (MDD), which is a common type of depression that can make everyday life quite challenging. The research is in a very early stage, often called 'Phase 1'. This means that the main purpose right now isn't to see if the medicine cures depression, but rather to understand how it behaves in the human body.

The researchers want to find out if DLX-001 is safe for people to take and if they can tolerate it without too many uncomfortable side effects. They also want to understand 'pharmacokinetics.' This simply means how the body processes the medicine: how much of it gets absorbed, how it's distributed around the body, how it's changed by the body, and how it eventually leaves the body. This information is really important because it helps scientists work out the right dose for future studies and to make sure it's as safe as possible.

Running these kinds of early studies is a vital step in developing any new medicine. By carefully checking the safety and how the body handles DLX-001, researchers can decide if it's promising enough to be tested in more people, and whether it might eventually become a new treatment option for depression.

Key takeaways

This study is for a new medicine, DLX-001, for Major Depressive Disorder.
It's an early-stage study (Phase 1) focused on safety and how the body handles the medicine.
Adults aged 18 and over, of any gender, can potentially participate.
Participation involves close medical monitoring and may include clinic stays.
You have the right to leave the study at any time.
This research helps pave the way for future treatments for depression.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, so older adults can also take part. The study is open to everyone, whether you are male or female.

The detailed rules about who can join are not provided here, but generally for studies like this, researchers look for participants who have a confirmed diagnosis of Major Depressive Disorder. They will also need to review your overall health, any other medical conditions you might have, and any medicines you are currently taking, to make sure it's safe for you to participate.

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 18 years old or older?
Do you have a diagnosis of Major Depressive Disorder?
Are you able to attend appointments and follow study instructions?
Are you willing to potentially change or stop other medications for the study?
Are you comfortable with various medical tests (like blood tests)?

Answer every question to see your result.

What does participation involve?

The specific details of what taking part involves aren't fully described, as this is an early-stage study summary. However, typically in a Phase I study like this, you would likely have an initial screening visit where doctors check your health and confirm you are suitable. If you qualify, you might then stay in a clinic for a short period, potentially a few days or longer, so that researchers can give you the study medicine and closely monitor your body's response.

During this time, you would have regular blood tests, physical examinations, and other assessments to track the medicine's safety and how it's processed in your body. There might be some follow-up visits after you leave the clinic to ensure your health remains good. The total duration of your involvement could range from a few weeks to a couple of months, depending on the study design.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit could be contributing to important medical research that might one day lead to new treatments for depression. You would also receive careful medical monitoring throughout the study. However, there are potential risks, as DLX-001 is a new medicine, and its full effects, including side effects, are not yet completely known. You might experience unexpected side effects, or the medicine might not have any beneficial effect for you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is Major Depressive Disorder (MDD)?

MDD is a serious medical illness that affects how you feel, think, and act. It can cause feelings of sadness and/or a loss of interest in activities you once enjoyed, and can lead to a variety of emotional and physical problems.

What does 'Phase 1' mean for a medicine?

Phase 1 means it's one of the very first times a new medicine is being tested in humans. The main goal is to check if it's safe, how adults tolerate it, and how their bodies handle the medicine, not yet to cure a condition.

Will DLX-001 help my depression during this study?

The primary goal of this early-stage study is to understand safety and how the medicine works in the body, not to treat depression. While some people might feel a change, it's not guaranteed or the main aim.

Can I continue taking my current depression medication?

This will depend on the specific rules of the study. It's very common for participants in early studies to have to stop certain medications for a period. This is something you must discuss with the study team and your own doctor.

Who is funding this study?

The funding source for this particular study is not mentioned in the information provided. Clinical trial information often includes this detail, and you can ask the study team for this information if you're considering taking part.