Actively Recruiting
Enoxolone in Major Depression - Biomarker-outcome Relationship
Led by Philipps University Marburg · Updated on 2025-12-08
80
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
P
Philipps University Marburg
Lead Sponsor
S
Slovak Academy of Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Enoxolone in Major Depression - Biomarker-outcome Relationship
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unipolar depression
- For women, use of contraceptive methods
You will not qualify if you...
- Diagnosis of schizophrenic or delusional disorders
- Neurological diseases affecting the central nervous system such as epilepsy or storage diseases, or severe mental retardation
- Moderate or severe internal diseases that make study participation risky, including systolic blood pressure above 145 mm Hg after 5 minutes supine, hypokalemia (less than 3.5 mmol/l), or significant ECG changes
- Poorly controlled diabetes mellitus with HbA1c above 10
- Pregnancy or active desire to become pregnant during the study
- Inability or unwillingness to consent to the study
- Treatment with spironolactone, eplerenone, or systemic glucocorticoids
- Treatment with ketamine or electroconvulsive therapy within 3 months before randomization
- Acute suicidality
- Intolerance to licorice preparations or products containing licorice
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, Germany, 35039
Actively Recruiting
Research Team
U
Ulrich Schu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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