Using Enoxolone to Improve Treatment Response in Major Depression
Official title: 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
Run by Philipps University Marburg · NCT05570110 · Data updated 2026-11-12
This study is testing whether enoxolone, a compound from licorice, can help people with major depression who haven't responded to other treatments feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Philipps University Marburg Academic / other |
| Locations | 1 site (Marburg, Hesse) |
| Status | Recruiting |
| Started | September 23, 2022 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT05570110 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women diagnosed with unipolar depression who are using contraceptive methods.
✕Probably not a fit
Patients with schizophrenia, severe neurological disorders, or those with poorly controlled diabetes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of enoxolone, a compound derived from licorice, on patients with unipolar depression, particularly focusing on those who exhibit therapy resistance. The study aims to identify biomarkers that predict treatment response and assess whether enoxolone can reverse these markers to enhance clinical outcomes. Participants will be randomized to receive either enoxolone or a placebo, with a focus on measuring changes in specific biomarkers and their correlation with clinical improvement. The trial seeks to provide insights into the relationship between biological markers and treatment efficacy in depression.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with major depression who currently struggle with therapy resistance.
How similar studies have gone: Other studies have explored the role of biomarkers in depression treatment, but the specific use of enoxolone in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unipolar Depression * in women: Contraceptive means Exclusion Criteria: * Schizophrenic and delusional disorders * Neurological diseases in which central nervous system involvement is known, such as epilepsies, storage diseases; severe mental retardation * Internistic diseases of moderate or higher severity, which may make participation in the study risky from a clinical point of view. In particular, multiple systolic blood pressure (measured after at least 5 min supine position) of \> 145 mm Hg as well as hypokalemia (\< 3.5 mmol/l) and clinically relevant ECG changes * Poorly controlled diabetes mellitus (HbA1c \> 10) * Pregnancy or active desire for pregnancy for the duration of the study * Non-consent or inability to consent to the study * Treatment with the following substances: spironolactone or eplerenone; systemic glucocorticoids * Treatment with ketamine or electroconvulsive therapy in the last 3 months before randomization * Acute suicidality * Intolerance to licorice preparations or licorice contents.
Where it's running
-
Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, Germany Recruiting
Study contacts
- Study coordinator: Ulrich Schu, MD
- Email: schu@uni-marburg.de
- Phone: +49 6421 5865200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.