NCT05570110 Enoxolone in Major Depression - Biomarker-outcome Relationship
| NCT ID | NCT05570110 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Philipps University Marburg |
| Condition | Unipolar Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-09-23 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2022-09-23 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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/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.
Eligibility 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.
Contact & Investigator
Harald Murck, MD PhD
STUDY DIRECTOR
Philipps University Marburg
Frequently Asked Questions
Who can join the NCT05570110 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05570110 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05570110 currently recruiting?
Yes, NCT05570110 is actively recruiting participants. Contact the research team at schu@uni-marburg.de for enrollment information.
Where is the NCT05570110 trial being conducted?
This trial is being conducted at Marburg, Germany.
Who is sponsoring the NCT05570110 clinical trial?
NCT05570110 is sponsored by Philipps University Marburg. The principal investigator is Harald Murck, MD PhD at Philipps University Marburg. The trial plans to enroll 80 participants.
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