RecruitingPHASE1INTERVENTIONAL

A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults

This research study is trying to understand a new drug called MSP-2020. We want to see how well it connects with certain targets in the brain called serotonin 5-HT2A receptors, which are important for mood. We're also checking how much of the drug stays in the blood and for how long. This is a very early-stage study (Phase 1) focused on safety and how the drug behaves in the body. It involves healthy men between 23 and 55 years old. The information we gather will help us develop better treatments for people with depression who haven't found enough relief from current options.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Enrolment target

Start

15 Jan 2026

Estimated completion

11 Feb 2027

Incomplete Response - Major Depressive Disorder (IR-MDD)

What is this study about?

This study is an important first step in understanding a new potential medicine called MSP-2020. We know that some people with depression don't get enough help from the treatments currently available. This study aims to find out how MSP-2020 works in the brain by looking at how well it attaches to specific areas called serotonin 5-HT2A receptors. These receptors are like tiny switches in the brain that influence mood and other functions. By understanding this connection, we can learn more about how the drug might help improve symptoms of depression.

Alongside understanding how the drug acts in the brain, researchers will also be checking the safety of MSP-2020. They will carefully monitor how much of the drug enters the bloodstream, how long it stays there, and whether it causes any side effects. This is a crucial part of developing any new medicine, as ensuring its safety is paramount. This initial study only involves healthy male volunteers.

The information gathered from this study will help researchers decide if MSP-2020 is promising enough to test in larger studies involving people with depression. Ultimately, the goal is to develop more effective and safer treatments for individuals experiencing depression who haven't found enough relief from existing options.

Key takeaways

This is an early study of a new drug, MSP-2020, for depression.
It aims to understand how the drug works in the brain and its safety.
Only healthy men aged 23-55 can take part.
Participation involves staying at a research centre and having brain scans and blood tests.
The findings could lead to new treatments for depression in the future.

Who may be eligible?

This study is looking for healthy men between the ages of 23 and 55. You would need to be able to stay in a special research unit for up to four days. Your body mass index (BMI) should be between 18.0 and 32.0. To make sure you're healthy enough, a doctor will check your medical history, do a physical exam, and run several tests like blood tests, a heart check (ECG and echocardiogram), and check your overall health.

There are several reasons why you might not be able to join. For example, if you or a close family member has a history of certain mental health conditions like schizophrenia or bipolar disorder. You also can't have certain implants in your body (like pacemakers) that would make having an MRI scan unsafe, or if you get very nervous in small spaces (claustrophobia). If you've had a lot of radiation exposure from previous research studies, you also might not be able to participate. You will also need healthy blood flow to your wrist.

Basically, the research team needs to make sure it's safe for you to take part and that the study results won't be affected by other health conditions. They will go through a full list of criteria with you to see if this study is a good fit.

Quick self-check

Are you a man aged between 23 and 55?
Are you generally healthy and active?
Do you have a Body Mass Index (BMI) between 18 and 32?
Do you feel comfortable in small spaces (for MRI scans)?
Do you have any metal implants or fragments in your body?
Is there any history of schizophrenia or bipolar disorder in your immediate family?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would need to be healthy and a man between 23 and 55 years old. The study involves staying at a research centre for up to four days. During this time, you will receive the study drug, MSP-2020. Researchers will regularly take blood samples to measure the drug levels and monitor your health carefully. You will also have special brain scans called PET scans and MRI scans to see how the drug interacts with your brain. Before you start, you'll have a thorough health check-up, including blood tests, a heart check, and a physical exam. The total duration of your involvement, including screening and follow-up, will be explained during the consent process.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might not directly benefit from taking part, but the information gained could help develop new treatments for others with depression in the future. Potential risks include side effects from the study drug, discomfort from blood tests or scans, and exposure to a small amount of radiation from the PET scans. All medical procedures carry some level of risk. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

HMR Hammersmith Medicines Research Ltd.
London, United Kingdom· Recruiting

Common questions

What is MSP-2020?

MSP-2020 is a new drug being studied to see how it works in the brain. It's hoped it could help people with depression in the future.

Why are only men included in this study?

Early-stage studies often limit participants to a specific group, like healthy men, to understand the basic safety and how the drug moves through the body without many other factors complicating the results. Future studies might include women.

What are serotonin 5-HT2A receptors?

These are like tiny docking stations or switches on brain cells that serotonin, a brain chemical, connects to. They play a role in mood and other brain functions.

What is a brain imaging study?

This means you will have special scans, like PET and MRI, to take pictures of your brain. These pictures help researchers see how the study drug is working inside your head.

Will I get paid for being in the study?

The study information doesn't say, but often participants in research studies receive some payment for their time and inconvenience. This is a good question to ask the research team.

How to find out more

Otsuka Call Center

Otsuka-ProfessionalServices@otsuka-us.com 844-687-8522 Official trial record

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