AuthorisedTherapeutic exploratory (Phase II)Interventional

Ketamine maintenance treatment for depression: A multicenter open-label randomized controlled trial

This research trial is investigating whether ketamine treatment can help people who suffer from severe depression, also known as Major Depressive Disorder (MDD). The main goal is to find out how long the positive effects of ketamine last and if it can stop depression from coming back after the initial treatment. Researchers will compare different ways of using ketamine to see which is most effective at preventing relapse. They will closely monitor participants for any side effects and how they feel throughout the study. This is an early-stage study, meaning it's exploring new ways to use ketamine for depression.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ostfold Hospital Trust

Enrolment target

230

Start

05 Nov 2025

Major Depression Disorder (MDD)

What is this study about?

This study is looking into a treatment called ketamine for people who have major depression. Major depression is a serious condition that can make everyday life very difficult. While there are existing treatments, researchers are always looking for new and more effective ways to help people feel better and stay well.

Ketamine has shown promise in treating depression, and this study aims to understand how to use it safely and effectively over a longer period. The main thing researchers want to find out is how long people stay free from depression symptoms after they've had ketamine treatment. They will be comparing different approaches to see which one best helps to prevent depression from returning.

Another important part of the study is to carefully check for any side effects from the ketamine treatment and how often they happen. By gathering this information, the study hopes to learn more about how to use ketamine as a potential long-term treatment for depression, helping more people manage their condition and improve their quality of life.

Key takeaways

This study is testing ketamine for severe depression.
It aims to see how long ketamine's positive effects last and prevent depression from returning.
The study will closely monitor for any side effects.
It's open to adults aged 18 and over, both men and women.
Your participation helps researchers understand new depression treatments.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can be considered.

This study is for both men and women. The main requirement is that you have been diagnosed with Major Depressive Disorder (MDD), which is a type of severe depression.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Major Depressive Disorder (severe depression)?
Are you able to commit to regular hospital visits for treatment and check-ups?
Are you comfortable with the idea of receiving an investigational treatment?

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, the study involves receiving ketamine treatment. Researchers will regularly check how you are feeling using questionnaires and discussions about your depression symptoms. They will also keep track of any side effects you might experience.

The study will follow you from the very beginning, through your ketamine treatments, and for a period afterwards to see how long the effects last. You will have regular appointments and check-ups with the study team. The overall duration of your involvement will depend on the phase of the study, but it's designed to monitor you for a significant period to understand the long-term effects of the treatment.

Potential risks and benefits

Potential benefits of taking part could include an improvement in your depression symptoms and finding a treatment that helps reduce the chance of your depression returning. However, as with all treatments, there are potential risks, and ketamine can have side effects. These will be carefully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Norway

Common questions

What is ketamine?

Ketamine is a medicine that is being studied for its potential in treating severe depression.

What is Major Depressive Disorder (MDD)?

MDD is a type of severe depression that can significantly affect a person's mood and daily life.

Will I know if I'm getting ketamine?

This study is 'open-label,' meaning you will know if you are receiving ketamine treatment.

What are 'side effects'?

Side effects are unwanted or unexpected reactions to a medicine or treatment.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time without giving a reason, and it won't affect your future medical care.