RecruitingPHASE2INTERVENTIONAL

A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD

This research is looking into a new medicine called GM-2505 for people with moderate to severe depression. We want to see how safe the medicine is and if it helps to improve symptoms of depression. We are inviting adults aged 18 to 65 to join if they have major depressive disorder. The study has different parts. Some people will try GM-2505 who aren't currently taking anti-depressants. Others will try it alongside their current anti-depressant if their depression hasn't fully improved with their usual medicine. We'll also check for any side effects and how people feel emotionally during the study.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Gilgamesh Pharmaceuticals

Enrolment target

124

Start

31 Jan 2024

Estimated completion

01 Oct 2026

Major Depressive Disorder

What is this study about?

This study is designed to learn more about a new potential medicine, called GM-2505, for adults who are living with major depressive disorder (often just called depression). We know that finding effective treatments for depression is very important, and this study aims to see if GM-2505 could be a helpful option in the future.

The study is divided into three main parts, each looking at slightly different situations. In one part, we'll give GM-2505 to people who aren't currently taking other antidepressant medications. This helps us understand what the new medicine does on its own. In another part, we'll see if GM-2505 can help people whose depression hasn't fully responded to their usual antidepressant medicine (like an SSRI or SNRI). A third part will re-evaluate the findings of the first part, but with a different dose.

Our main goals are to check how safe GM-2505 is, to see if there are any side effects, and to understand if it can help improve symptoms of depression. Your participation could help us gather important information that might eventually lead to new treatments for depression.

Key takeaways

This study is testing a new medicine for moderate to severe depression.
It aims to check the safety and effectiveness of GM-2505.
Participants will be adults aged 18-65 with major depressive disorder.
Some participants may try GM-2505 alone; others will take it with their current antidepressant.
The study involves regular clinic visits for assessments and health checks.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old. You must have been diagnosed with moderate to severe major depressive disorder, and importantly, you shouldn't have other serious mental health conditions like a psychotic disorder, bipolar disorder, or certain personality disorders.

If you're interested, there are slightly different requirements depending on which part of the study you might join. For example, if you're not currently taking antidepressant medication, you might be eligible for one part. If you are already taking a stable dose of an antidepressant (like an SSRI or SNRI) but your depression isn't fully controlled, you might be eligible for another part.

You also need to be willing to follow the study plan, which includes avoiding new depression medicines if you're in one group, or continuing your current medicine if you're in another. If you're having counselling or therapy, you'd need to continue with that throughout the study.

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?
Have you been diagnosed with moderate to severe depression?
Do you *not* have a diagnosis of a psychotic disorder or bipolar disorder?
Are you able to attend regular clinic visits for several weeks or months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to the study clinic. These visits will involve various assessments to check your mental health, such as questionnaires and interviews, to see how you are feeling and if the study medicine is making a difference. You will also have health checks, including blood tests, to monitor your general well-being and make sure the new medicine is safe for you.

Depending on which part of the study you join, you might be asked to take the study medicine, GM-2505, either as your only depression treatment or alongside your current antidepressant medication. The total duration of your participation in the study will vary, but it will involve regular appointments over several weeks or months. We'll give you a detailed schedule of visits and what each visit will involve.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that GM-2505 might help to improve your symptoms of depression. You will also receive close medical attention and monitoring throughout the study. However, like all medicines, GM-2505 could have side effects, which might range from mild to more serious. There's also no guarantee that the medicine will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

MAC Clinical Research
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is major depressive disorder?

Major depressive disorder is a serious mental health condition that affects your mood, thoughts, and behaviour. It can cause ongoing feelings of sadness, loss of interest in activities, and changes in sleep or appetite.

What is GM-2505?

GM-2505 is a new medicine being tested in this study to see if it can help with symptoms of depression. We are still learning how it works and if it is effective and safe.

Will I stop my current antidepressant?

It depends on which part of the study you're in. Some people will not be taking any antidepressants, while others will take GM-2505 alongside their current antidepressant medicine.

How long will the study last?

The total length of time you participate in the study will vary, but it will involve several weeks or months of regular visits and assessments.

Can I leave the study if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Jason Winters

jason@gilgameshpharmaceutical.com 6097385579 Official trial record

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