RecruitingPhase 1Phase 2NCT05570110

Enoxolone in Major Depression - Biomarker-outcome Relationship

Double-blind Randomized Placebo Controlled Study on the Effect of Enoxolone ( 11-beta Hydroxysteroid-dehydrogenase Type 2 Inhibitor) on the RAAS, Autonomic and Imaging Biomarkers and the Outcome of Depression

Sponsor

Philipps University Marburg

Enrollment

80 participants

Start Date

Sep 23, 2022

Study Type

INTERVENTIONAL

Conditions

Unipolar Depression

Summary

Many different forms of depression exist. It is difficult to predict to what treatment a given patient with depression responds. Studies demonstrate that biomarkers can help to distinguish different forms of depression. Simple markers, like aldosterone/cortisol in body fluids, blood pressure and inflammation markers , have been identified as predictors of therapy resistance in depression. Enoxolone is a molecule derived from the licorice plant and has demonstrated an effect on these biomarkers, which may imply an improved response. The current randomized placebo controlled study is assessing whether the presence of markers of therapy resistance can predict a preferential effect of enoxolone vs. placebo on clinical outcome. Secondarily, it is tested whether these markers change differentially in the treatment groups. Finally, the relationship between the change of the markers and clinical change will be assessed.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is investigating enoxolone — a compound derived from licorice root — as a potential treatment for major depression. The study is also analyzing biomarkers (biological measurements in blood or urine) to understand which patients respond best, which may help personalize depression treatment in the future. **You may be eligible if...** - You have been diagnosed with unipolar (non-bipolar) major depression - You are a woman using contraception during the study period **You may NOT be eligible if...** - You have schizophrenia or delusional disorders - You have neurological diseases affecting the brain (e.g., epilepsy, storage diseases, severe intellectual disability) - You have moderate-to-severe internal medical conditions, including repeatedly high blood pressure (over 145 mmHg systolic), low potassium levels, or significant ECG changes - You have poorly controlled diabetes (HbA1c above 10) - You are pregnant or trying to become pregnant - You take spironolactone, eplerenone, or systemic corticosteroids - You have had ketamine or electroconvulsive therapy (ECT) in the past 3 months - You are at risk of suicide - You have an intolerance to licorice or licorice-derived products Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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