AuthorisedTherapeutic confirmatory (Phase III)Interventional

RESET-TRD; a Randomised trial on oral ESketamine compared to Electroconvulsive Therapy for patients with Treatment Resistant Depression

This study, called RESET-TRD, is looking at a new oral medicine called esketamine. It's for adults in the UK who have severe depression that hasn't improved with standard treatments. This type of depression is sometimes called 'treatment-resistant depression'. The study compares esketamine taken by mouth with another treatment called Electroconvulsive Therapy (ECT). We want to find out if oral esketamine helps people feel better over 8 weeks, specifically if it can reduce depression symptoms by at least 30%. The study also checks how well these treatments prevent depression from coming back over a year. The main goal is to see if esketamine is as effective as ECT.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

172

Start

12 Nov 2024

Non-psychotic therapy resistant unipolar depression

What is this study about?

If you're living with depression that hasn't gotten better with regular treatments, you might be interested in a new research study called RESET-TRD. This study is for people in the UK who have unipolar depression, which means they experience periods of low mood but not extreme highs (mania). The depression is also 'treatment-resistant,' meaning it hasn't improved after trying other common therapies.

The main idea behind this study is to compare two different ways of treating this kind of depression. One treatment is a new oral medicine called esketamine. The other is Electroconvulsive Therapy, often known as ECT, which is an established treatment for severe depression. Researchers want to see if taking esketamine by mouth can help people improve as much as ECT does over an 8-week period. They'll be looking for a significant reduction in depression symptoms to measure how well each treatment works.

Beyond the initial 8 weeks, the study will also follow people for a longer period, up to 12 months. This is to understand if the treatments can help keep depression from returning. By comparing oral esketamine with ECT, the study hopes to find more effective and potentially easier-to-access treatment options for people with severe, hard-to-treat depression.

Key takeaways

A study for adults with severe, hard-to-treat depression.
Compares oral esketamine medicine with Electroconvulsive Therapy (ECT).
Aims to see if esketamine is as effective as ECT over 8 weeks.
Also checks how well treatments prevent depression from returning over a year.
Participation involves random assignment to one treatment.
Close medical monitoring throughout the study period.

Who may be eligible?

This study is looking for adults who are 18 years old or older. There is no upper age limit, so people of all adult ages can potentially take part. Both men and women are welcome to participate in the study.

The most important health requirement for this study is that you must have depression that is considered 'treatment-resistant'. This means your depression hasn't responded well to other treatments you've tried. You also need to have 'unipolar depression,' meaning you experience periods of low mood but not extreme highs (mania). Critically, for this study, your depression should not involve psychosis, which means you shouldn't be experiencing symptoms like hallucinations or delusions.

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?
Have you been diagnosed with depression?
Has your depression not improved with other treatments?
Do you experience low moods but not extreme highs (mania)?
Do you not experience symptoms like hallucinations or delusions related to your depression?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the oral esketamine medicine or Electroconvulsive Therapy (ECT). This means you wouldn't get to choose which treatment you receive. Both treatments would be given over an 8-week period. Throughout this time, and for a follow-up period of up to 12 months, you would have regular appointments for assessments. These assessments will help the study team understand how well the treatment is working and monitor your health. They might involve filling out questionnaires about your mood and symptoms, or having discussions with the study doctors. The total duration of your participation in the study, including treatment and follow-up, could be up to 12 months.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as access to a new treatment or close medical monitoring for your depression. However, like all medical treatments, both esketamine and ECT have potential side effects or risks, which your doctor will discuss with you. You will be closely monitored for any unwanted effects. It's very important to remember that joining a study is always your choice, and you are free to withdraw at any time without giving a reason, and it will not affect 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 'treatment-resistant depression'?

This is a type of depression that hasn't gotten better even after trying standard treatments like talking therapies or antidepressant medications.

What is esketamine?

Esketamine is a medicine that, in this study, is given by mouth. It works differently from traditional antidepressants and is being investigated for severe depression.

What is ECT?

ECT, or Electroconvulsive Therapy, is a medical procedure that involves passing small electrical currents through the brain to trigger a brief seizure. It's an established treatment for severe mental health conditions, especially depression.

Will I get to choose my treatment?

No, you would be randomly assigned to either receive the oral esketamine or ECT. This is so researchers can fairly compare the two treatments.

How long does the study last?

The main treatment period is 8 weeks, but you would be followed up for a total of up to 12 months to see how well the treatment works in the longer term.