Using Enoxolone to Improve Treatment Response in Major Depression
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
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Philipps University Marburg Academic / other |
| Locations | 1 site (Marburg, Hesse) |
| Trial ID | NCT05570110 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with unipolar depression who are using contraceptive methods.
Not a fit: Patients with schizophrenia, severe neurological disorders, or those with poorly controlled diabetes may not benefit from this study.
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 performed: Other studies have explored the role of biomarkers in depression treatment, but the specific use of enoxolone in this context is relatively novel.
Eligibility criteria
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 this trial is running
Marburg, Hesse
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.