Enoxolone in Major Depression - Biomarker-outcome Relationship

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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 from the saliva, blood pressure and inflammation markers from the blood, have been identified as predictors of a more difficult to treat depression. Enoxolone is a molecule derived from the licorice plant and has demonstrated an effect on these biomarkers, which may indicate a better response. In a randomized placebo controlled trial this study is assessing whether the administration of enoxolone vs. placebo can change these markers and if patients benefit from these biomarker changes clinically. In addition, this study records the volume and structure of certain brain areas, which could be involved in this action.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philipps University Marburg Medical Center
• Collaborator: Slovak Academy of Sciences
• Treatments: Glycyrrhetinic Acid

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.