RecruitingOBSERVATIONAL

Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression

This study is for people with depression that hasn't improved with standard medications, known as 'treatment-resistant depression'. Researchers want to understand why some people respond well to lithium, a depression medication, while others don't. They're using various tests, including brain scans, blood tests, and memory checks, to find unique signals in people who benefit from lithium. The goal is to develop a way to predict who is most likely to be helped by lithium, so doctors can offer more personalised and effective treatment for this challenging form of depression.

At a glance

Status

Recruiting

Sponsor

Max-Planck-Institute of Psychiatry

Enrolment target

130

Start

02 Apr 2024

Estimated completion

01 Apr 2029

Depressive; Disorder, Major, Single Episode, Major, With Psychotic Symptoms Depressive; Disorder, Major, Single Episode, Major (Without Psychotic Symptoms)Depressive Disorder, Major, Recurrent, With Psychotic Symptoms Depressive Disorder, Major, Recurrent, Without Psychotic Symptoms Depressive Disorder, Treatment-Resistant, Class I or II Depressive Disorder, Major, Moderate Depressive Disorder, Major, Severe

What is this study about?

This study, called DECIDE, is looking into a difficult type of depression that hasn't gotten better with standard treatments. This is often called 'treatment-resistant depression'. For many people, it can be really frustrating when usual medications don't work.

The researchers want to find out if there are specific patterns or 'fingerprints' in people's bodies and brains that can tell us who will benefit from a medication called lithium. Lithium is a treatment option for some people with severe depression, but it doesn't work for everyone. By collecting lots of different information – like brain scans (MRI and EEG), comprehensive blood tests, assessments of thinking and memory, and detailed questionnaires about symptoms – they hope to build a clearer picture of who responds best.

Ultimately, the aim is to create a special tool, using computer programs, that can help doctors predict whether lithium will be a good treatment choice for an individual. This means that, in the future, if you have treatment-resistant depression, your doctor might be able to use this tool to decide if lithium is likely to help you, making your treatment journey more effective and personal. This study will not change how you are currently treated; the decision to use lithium will still be made by your doctor based on usual care guidelines.

Key takeaways

This study focuses on improving treatment for severe depression that hasn't responded to usual medications.
It aims to find out if specific 'fingerprints' in the body and brain can predict who will benefit from lithium.
The study involves various tests like brain scans, blood tests, and memory checks.
Participation will not change your current treatment; lithium decisions are made by your doctor.
The long-term goal is to help doctors offer more personalised treatment for depression.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with a specific type of major depression, known as 'treatment-resistant depression'. This means that previous antidepressant medications haven't worked well enough for them. To be considered, your doctor must also have decided that lithium might be a suitable treatment option for you.

There are certain reasons why someone might not be able to join. For example, if you have certain medical conditions that would make taking lithium unsafe, or if you've already had conditions like mania or hypomania (periods of unusually high energy or mood swings). People who have had certain brain conditions, like a stroke or epilepsy, or who are currently using certain other strong medications, might also not be able to participate. Also, if you've recently had treatments like ECT or rTMS for your depression, you would not be eligible.

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 major depression that hasn't responded well to previous treatments?
Has your doctor suggested lithium might be a suitable treatment option for you?
Do you not have certain serious medical issues that would conflict with lithium treatment?
Have you not had conditions like mania or certain brain disorders?

Answer every question to see your result.

What does participation involve?

This study is 'non-interventional', which means it runs alongside your usual medical care and doesn't involve giving you a new or experimental treatment. Your doctor will still decide if lithium is right for you, based on standard guidelines, completely separate from your involvement in the study. If you do take part, you'll be part of the 'Biobanking' project at the Max Planck Institute. This involves a series of assessments, including detailed questionnaires about your depression symptoms and overall health, blood tests, brain scans (MRI and EEG), and tests to check your thinking and memory skills. The study aims to gather detailed information about you as you go through your regular treatment. The total duration of your participation will depend on the assessments and follow-up needed to gather all the relevant information, but it won't change your prescribed treatment course.

Potential risks and benefits

Taking part in this study could eventually help researchers understand depression better, leading to more personalised treatments for others in the future. For you personally, there isn't a direct medical benefit from participating, as the study doesn't change your treatment. However, some people find it helpful to contribute to medical research. There are some small risks associated with the assessments, such as minor discomfort from blood tests or being in an MRI scanner. All procedures will be explained to you, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Max Planck Insitute of Psychiatry
Verified postcode
Munich, Germany· Recruiting

Common questions

What is 'treatment-resistant depression'?

It's when your depression hasn't significantly improved after trying at least one or two different antidepressant medications.

Will I be given new medicine if I join this study?

No, this study doesn't involve new medicines. Your doctor will decide your treatment plan, including whether to use lithium, based on what's best for you, outside of the study.

What kind of tests will I have if I join?

You'll have various tests, including brain scans (MRI and EEG), blood tests, memory and thinking tests, and surveys about your symptoms.

Will taking part affect my regular depression treatment?

No, your participation in the study won't change your current or planned depression treatment. Your doctor will make those decisions.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

How to find out more

Laura E Fischer, MD

decide@psych.mpg.de 0049-89-30622-1418 Official trial record

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