Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Monitoring the AD effects of ketamine in MDD patients

This research is investigating how a medication called ketamine works in people who have major depressive disorder, which is a type of severe depression. The main goal is to carefully observe the body's reactions and any side effects of ketamine, rather than testing if it effectively treats depression at this stage. It's a very early-stage study, often called Phase 1, where scientists give small doses of a new treatment to a small group of people to understand how it affects them. This helps them learn more about the medicine's safety and how it behaves in the human body. This information is crucial for deciding if it's safe to study the medicine further as a potential treatment for depression.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Centre for Human Drug Research

Enrolment target

Start

17 May 2024

Major depressive disorder

What is this study about?

This study is about a medicine called ketamine and how it affects people who have a condition known as Major Depressive Disorder. This is a severe form of depression that can significantly impact daily life. Researchers are interested in understanding the specific effects of ketamine in these patients.

At this early stage, often called 'Phase I' or 'Human Pharmacology,' the main goal isn't to see if ketamine cures depression. Instead, it's about learning more about how the body handles ketamine. This includes looking at how it's absorbed, distributed, and eventually leaves the body, and carefully monitoring any reactions or side effects people might have. Think of it like taking a very close look at how a new ingredient interacts with a recipe for the first time.

Understanding these early details is very important. It helps scientists determine if the medicine is safe enough to be studied further in larger groups of people and to find out if it genuinely has the potential to help with depression in the future. This foundational work helps ensure that any future treatments are developed as safely and effectively as possible.

Key takeaways

This study is about understanding ketamine's effects in severe depression.
It's an early-stage study, focusing on how the body reacts to the medicine.
It aims to gather safety information, not to cure depression at this point.
Participants must have Major Depressive Disorder.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. The specific age limit beyond 18 is not mentioned, meaning there isn't an upper age restriction for taking part.

To join, you must have been diagnosed with Major Depressive Disorder, which is a type of severe depression. This means the study is specifically looking for people who are currently experiencing this condition.

There will be other detailed health checks and requirements that you would need to meet to ensure the study is safe and appropriate for you. These will be discussed with you by the research team.

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 (severe depression)?
Are you a man or a woman?
Are you willing to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

Information about what taking part involves was not provided in the summary. Typically, for an early-stage (Phase I) study like this, you might expect several visits to a clinic or hospital for assessments, which could include blood tests, physical examinations, and mood questionnaires. You would likely receive the study medication (ketamine) during these visits, possibly through an infusion or injection, and be carefully monitored afterwards for a period. Follow-up appointments would also be expected to check on your health and any lasting effects. The total duration of participation can vary greatly but early-stage studies often involve short, intensive periods of monitoring.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. While this early-stage study may not directly improve your depression, it helps doctors learn more about ketamine, which could lead to better treatments for others in the future. Potential risks might include side effects from ketamine, such as feeling dizzy, nauseous, or experiencing changes in blood pressure, or discomfort from study procedures like blood tests. You have the right 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.

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Unverified
Netherlands

Common questions

What is ketamine?

Ketamine is a medicine that is being studied for its effects, particularly in people with severe depression. It's normally used as an anaesthetic but has shown promise in mental health research.

What is Major Depressive Disorder?

This is a serious type of depression that affects mood, thoughts, and behaviour, and can make it very hard to carry out daily activities.

What does 'Human Pharmacology (Phase I)' mean?

It means this is a very early study in humans, focusing on understanding how a medicine works in the body, its safety, and how much is needed, rather than directly testing if it cures a condition.

Will this study cure my depression?

The main goal of this particular study is not to cure depression but to gather important information about how ketamine affects the body. Any direct improvements would be a secondary finding.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your usual medical care.