NCT05570110RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Sept 2022
- Start date
- 23 Sept 2022
- Primary completion date
- Jun 2026
- Lead sponsor
- Philipps University Marburg
- Diseases
- Depression
- NCT number
- NCT05570110
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 23 Sept 2022 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with the following substances: spironolactone or eplerenone; systemic glucocorticoids
- Treatment with ketamine or electroconvulsive therapy in the last 3 months before randomization
Other illness
- Schizophrenic and delusional disorders
- Neurological diseases in which central nervous system involvement is known, such as epilepsies, storage diseases; severe mental retardation
Lab values
- 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)
Other
- Pregnancy or active desire for pregnancy for the duration of the study
- Non-consent or inability to consent to the study
- Acute suicidality
- Intolerance to licorice preparations or licorice contents.
Who the study is looking for
- Unipolar Depression
- in women: Contraceptive means
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinic for Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.