RecruitingPHASE1, PHASE2INTERVENTIONAL

Enoxolone in Major Depression - Biomarker-outcome Relationship

This research is exploring a new approach to treating depression using enoxolone, a substance found in liquorice. The study aims to understand why some people with depression respond better to certain treatments than others. Scientists have found some simple markers in the body, like levels of certain hormones (aldosterone and cortisol), blood pressure, and inflammation, that might show if someone will find it harder to get better with standard treatments. Enoxolone has been shown to affect these markers. This study wants to see if these markers can help predict if enoxolone works better than a dummy pill (placebo) for someone. It also checks if enoxolone changes these markers and how those changes relate to feeling better.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Philipps University Marburg

Enrolment target

Start

23 Sep 2022

Estimated completion

01 Jun 2026

Unipolar Depression

What is this study about?

Many people live with depression, and it's a condition that can affect everyone differently. This means that what helps one person might not be the best approach for another, making it tricky to find the right treatment from the start. Scientists are always trying to understand why this is and how they can make it easier to find effective help for each individual.

This study focuses on people who have unipolar depression, which is the most common type. Researchers are particularly interested in certain 'markers' in the body. Think of these markers like clues that tell us something about how the body is working. Some of these clues include levels of hormones like aldosterone and cortisol (which are linked to stress), your blood pressure, and signs of inflammation. Previous research suggests these markers might help understand why some people's depression is harder to treat.

Here's where enoxolone comes in. Enoxolone is a natural substance found in the liquorice plant. Studies have shown that enoxolone can influence these specific body markers. This trial aims to find out if having certain marker levels means a person is more likely to benefit from enoxolone compared to a placebo (a dummy pill). It will also investigate if enoxolone actually changes these markers, and whether that change is linked to improvements in how people feel.

Key takeaways

This study is testing enoxolone, a natural substance from liquorice, for depression.
It aims to see if specific body markers can predict who might benefit most from enoxolone.
The research focuses on unipolar depression and is in early stages (Phase 1/2).
You might take enoxolone or a dummy pill (placebo); you won't know which one.
Participation involves regular clinic visits, blood/urine tests, and mood assessments.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult over 18 who has been diagnosed with unipolar depression. If you are a woman and could become pregnant, you would also need to be using reliable contraception throughout the study.

There are certain reasons why you wouldn't be able to join. For example, if you have other serious mental health conditions like schizophrenia, certain neurological diseases (like epilepsy), or significant ongoing health problems that might make taking part risky. This includes very high blood pressure, low potassium levels, very poorly controlled diabetes, or certain heart issues.

You also can't be pregnant or actively trying to get pregnant. If you've recently had certain depression treatments like ketamine or electroconvulsive therapy (ECT), or if you're taking specific medications that interact with enoxolone (like spironolactone or eplerenone, or certain strong steroid medications), you wouldn't be eligible. Finally, if you're unable to give consent or have an allergy to liquorice or its ingredients, you can't participate.

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 unipolar depression?
If you are a woman, are you using reliable birth control?
Do you have good overall general health without serious ongoing medical conditions?
Are you able to agree to the study rules and participate actively?
Are you not allergic to liquorice or its ingredients?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either enoxolone or a placebo (a dummy pill) to take. You won't know which one you're receiving. The study involves several visits to the clinic for assessments. These will include checks of your blood pressure, blood and urine tests to look at the specific body markers, and questionnaires to track your mood and symptoms.

You will need to regularly take the study medication as instructed. The researchers will closely monitor your health and any side effects you might experience. The total duration of your participation in the study, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from the study treatment if it helps your depression symptoms or from the close medical monitoring you receive. However, there's also a chance that the treatment might not work for you, or you could experience side effects, as enoxolone can slightly increase blood pressure. It's important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Clinic for Psychiatry and Psychotherapy
Verified postcode
Marburg, Germany· Recruiting

Common questions

What is unipolar depression?

Unipolar depression, often just called depression, is a common mood disorder that causes a persistent feeling of sadness and loss of interest. It affects how you feel, think, and behave, and can lead to a variety of emotional and physical problems.

What is enoxolone?

Enoxolone is a substance found naturally in the root of the liquorice plant. It's being studied for its potential effects on certain body processes that might be linked to depression.

What is a placebo?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medication but contains no active ingredients. It's used in studies to see if the real drug is truly effective compared to just expecting to get better.

What are 'biomarkers'?

Biomarkers are measurable indicators in your body, like certain hormone levels in your blood or urine, or your blood pressure. They can give doctors clues about your health or how your body might respond to a treatment.

Will I know if I'm getting the drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're receiving enoxolone or the placebo until after the study is complete. This helps ensure the results are fair and unbiased.

How to find out more

Ulrich Schu, MD

schu@uni-marburg.de +49 6421 5865200 Official trial record

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