Unipolar DepressionPhase 1/2NCT05570110
Enoxolone in Major Depression - Biomarker-outcome Relationship
A Phase 1/2 study testing Enoxolone in people with Unipolar Depression, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Enoxolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 23 Sep 2022to Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unipolar Depression
- in women: Contraceptive means
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Clinic for Psychiatry and Psychotherapy
Marburg, Hesse, 35039
Ulrich Schu, MD, +49 6421 5865200, schu@uni-marburg.de
About this study
Official title: 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
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.
Read the detailed description
The objective of the study is 1. to confirm patient characteristics, which are related to lesser responsivity to antidepressant treatment and 2. to explore the utility of the 11-beta hydroxysteroid-dehydrogenase type 2 (11betaHSD2) and toll-like receptor (TLR)-4 inhibitor enoxolone to reverse these markers of refractoriness and, potentially, improve clinical outcome. A broad spectrum of patients is recruited in order to provide the opportunity to compare those with relevant markers of refractoriness vs. those without.
The identified markers are related to the activity of aldosterone, which appears to affect specific CNS areas, which are involved in mood and autonomic regulation. One area of particular relevance is the pontine nucleus of the solitary tract (NTS). Potential primary triggers for an increased aldosterone release under stressful conditions are related to low blood pressure, electrolyte alterations and a dysfunction of the peripheral mineralocorticoid receptor (MR). The resultant aldosterone release evokes activity at the NTS, which may lead to depression and anxiety.
Enoxolone leads to an activation primarily of the peripheral MR by reducing the activity of the 11betaHSD2, therefore allowing cortisol access to the MR and, as a consequence, suppress the release of renin, angiotensin and aldosterone. In addition, it can increase blood pressure slightly.
- A set of potentially predictive markers for therapy response of enoxolone vs. placebo will be studied, based on this mechanistic pathway, in detail: For the primary analysis subjects are grouped into those with higher vs. lower systolic blood pressure values, as determined by the median systolic blood pressure value at baseline. For the secondary analysis the ratio of urine aldosterone/cortisol, as collected over night will be used as a differentiating parameter. Split at the median defines the groups. Exploratory parameters for a split are the following:
- sleep duration
- heart rate variability
- salt taste sensitivity and salt preference
- inflammation markers, in particular C-reactive protein in plasma.
- Optional: volumes of lateral ventricles, corpus callosum and choroid plexi.
- Optional: white matter integrity, as measured by diffusion tensor imaging
- Markers of target engagement:
- Effect of enoxolone vs. placebo on systolic blood pressure.
- Effect of enoxolone vs. placebo on urine aldosterone/cortisol concentration.
- Effect of enoxolone vs. placebo on plasma sodium/potassium concentration ratio.
- Effect of enoxolone on C-reactive protein and other inflammation markers.
- The relationship between changes in hormone concentrations and markers of CNS activation of MR, i.e. functional CNS target engagement. These are:
- Heart rate variability and heart rate
- Systolic blood pressure at rest and nocturnal blood pressure dip
- Total sleep time
- Salt taste preference and sensitivity
- Inflammatory markers
- Optional: volumes of lateral ventricles, corpus callosum and choroid plexi.
- Optional: white matter integrity, as measured by diffusion tensor imaging
- Conditions
- Unipolar Depression
- Being tested
- Enoxolone
- Keywords
- Atypical depression;
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxoloneDrug
Also called glycyrrhetinic acid
one capsule of active or placebo in the evening
| Study group | Role | What they receive |
|---|---|---|
| enoxolone | Experimental | 100 mg enoxolone in a capsule Receives: Drug: Enoxolone |
| placebo | Placebo comparator | Placebo in a capsule Receives: Drug: Enoxolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and urine aldosterone/cortisol ratio
ratio of plasma aldosterone/cortisol at awakening; ratio of nocturnal urine aldosterone concentration/urine cortisol concentration
Measured: Baseline, as predictor for differentiation of treatment groups clinical response
C-reactive protein
C-reactive protein in plasma
Measured: Baseline, as predictor for differentiation of treatment groups clinical response and change from baseline (4 weeks)
Systolic blood pressure
Systolic blood pressure at rest at baseline as a predictor for treatment differentiation
Measured: Baseline, as predictor for differentiation of treatment groups clinical response
Depression rating
Hamilton depression rating scale (HAMD) - 17 items; higher is worse
Measured: change from baseline to week 4, with systolic blood pressure as covariate
Secondary outcomes (8)
Urine aldosterone/cortisol ratio
Ratio of nocturnal urine aldosterone concentration/urine cortisol concentration
Measured: change from baseline to week 4
Plasma ratio of sodium/potassium
Ratio of the plasma concentration of sodium/ plasma concentration of potassium
Measured: change from baseline to week 4
Nocturnal heart rate variability
Average nocturnal heart rate variability, expressed as stress level (Garmin, arbitrary unit)
Measured: change from baseline to week 4
Nocturnal blood pressure dip (difference between pre-sleep and minimal nocturnal blood pressure
Minimum of continuously monitored systolic blood pressure (mmHg)
Measured: change from baseline to week 4
Depression self rating
Patient health questionnaire-9 (PHQ-9), higher is worse
Measured: change from baseline to week 4
Total sleep duration
Total sleep duration, as determined by wearable device (Garmin) (minutes)
Measured: change from baseline to week 4
Salt taste preference and sensitivity
salt taste preference, as determined by tasting a 0.9% NaCl solution, 11 item Likert scale (Murck et al., 2018)
Measured: change from baseline to week 4
Rating for symptoms of normal pressure hydrocephalus
Idiopathic normal pressure hydrocephalus grading scale (iNPHGS) (Kubo et al., 2008), higher is worse
Measured: change from baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start23 Sep 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group design, first two subjects open label.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Slovak Academy of Sciences
- Responsible party
- Principal investigator, Harald Murck, Philipps University Marburg
- Investigators
- Harald Murck, MD PhD, Study director, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570110
- Sponsor's protocol ID
- MNS_02.1
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share study data in concordance with local regulations
Publications
Murck H. Discovery of Personalized Treatment for Immuno-Metabolic Depression-Focus on 11beta Hydroxysteroid Dehydrogenase Type 2 (11betaHSD2) and Toll-like Receptor 4 (TLR4) Inhibition with Enoxolone. Pharmaceuticals (Basel). 2025 Oct 10;18(10):1517. doi: 10.3390/ph18101517.
PubMed 41155634Murck H, Luerweg B, Hahn J, Braunisch M, Jezova D, Zavorotnyy M, Konrad C, Jansen A, Kircher T. Ventricular volume, white matter alterations and outcome of major depression and their relationship to endocrine parameters - A pilot study. World J Biol Psychiatry. 2021 Feb;22(2):104-118. doi: 10.1080/15622975.2020.1757754. Epub 2020 May 15.
PubMed 32306867Murck H, Lehr L, Hahn J, Braunisch MC, Jezova D, Zavorotnyy M. Adjunct Therapy With Glycyrrhiza Glabra Rapidly Improves Outcome in Depression-A Pilot Study to Support 11-Beta-Hydroxysteroid Dehydrogenase Type 2 Inhibition as a New Target. Front Psychiatry. 2020 Dec 10;11:605949. doi: 10.3389/fpsyt.2020.605949. eCollection 2020.
PubMed 33362613Engelmann J, Murck H, Wagner S, Zillich L, Streit F, Herzog DP, Braus DF, Tadic A, Lieb K, Muller MB. Routinely accessible parameters of mineralocorticoid receptor function, depression subtypes and response prediction: a post-hoc analysis from the early medication change trial in major depressive disorder. World J Biol Psychiatry. 2022 Oct;23(8):631-642. doi: 10.1080/15622975.2021.2020334. Epub 2022 Jan 25.
PubMed 34985381Murck H, Braunisch MC, Konrad C, Jezova D, Kircher T. Markers of mineralocorticoid receptor function: changes over time and relationship to response in patients with major depression. Int Clin Psychopharmacol. 2019 Jan;34(1):18-26. doi: 10.1097/YIC.0000000000000239.
PubMed 30300165
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05570110
- Acronym / sponsor ID
- MNS_02.1
- Conditions
- Unipolar Depression
- Keywords
- Atypical depression;
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Slovak Academy of Sciences
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the study is 1. to confirm patient characteristics, which are related to lesser responsivity to antidepressant treatment and 2. to explore the utility of the 11-beta hydroxysteroid-dehydrogenase type 2 (11betaHSD2) and toll-like receptor (TLR)-4 inhibitor enoxolone to reverse these markers of refractoriness and, potentially, improve clinical outcome. A broad spectrum of patients is recruited in order to provide the opportunity to compare those with relevant markers of refractoriness vs. those without.
The identified markers are related to the activity of aldosterone, which appears to affect specific CNS areas, which are involved in mood and autonomic regulation. One area of particular relevance is the pontine nucleus of the solitary tract (NTS). Potential primary triggers for an increased aldosterone release under stressful conditions are related to low blood pressure, electrolyte alterations and a dysfunction of the peripheral mineralocorticoid receptor (MR). The resultant aldosterone release evokes activity at the NTS, which may lead to depression and anxiety.
Enoxolone leads to an activation primarily of the peripheral MR by reducing the activity of the 11betaHSD2, therefore allowing cortisol access to the MR and, as a consequence, suppress the release of renin, angiotensin and aldosterone. In addition, it can increase blood pressure slightly.
- A set of potentially predictive markers for therapy response of enoxolone vs. placebo will be studied, based on this mechanistic pathway, in detail: For the primary analysis subjects are grouped into those with higher vs. lower systolic blood pressure values, as determined by the median systolic blood pressure value at baseline. For the secondary analysis the ratio of urine aldosterone/cortisol, as collected over night will be used as a differentiating parameter. Split at the median defines the groups. Exploratory parameters for a split are the following:
- sleep duration
- heart rate variability
- salt taste sensitivity and salt preference
- inflammation markers, in particular C-reactive protein in plasma.
- Optional: volumes of lateral ventricles, corpus callosum and choroid plexi.
- Optional: white matter integrity, as measured by diffusion tensor imaging
- Markers of target engagement:
- Effect of enoxolone vs. placebo on systolic blood pressure.
- Effect of enoxolone vs. placebo on urine aldosterone/cortisol concentration.
- Effect of enoxolone vs. placebo on plasma sodium/potassium concentration ratio.
- Effect of enoxolone on C-reactive protein and other inflammation markers.
- The relationship between changes in hormone concentrations and markers of CNS activation of MR, i.e. functional CNS target engagement. These are:
- Heart rate variability and heart rate
- Systolic blood pressure at rest and nocturnal blood pressure dip
- Total sleep time
- Salt taste preference and sensitivity
- Inflammatory markers
- Optional: volumes of lateral ventricles, corpus callosum and choroid plexi.
- Optional: white matter integrity, as measured by diffusion tensor imaging
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel group design, first two subjects open label.
| Arm | Type | Receives |
|---|---|---|
| enoxolone | Experimental | Drug: Enoxolone100 mg enoxolone in a capsule |
| placebo | Placebo comparator | Drug: EnoxolonePlacebo in a capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unipolar Depression
- in women: Contraceptive means
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoxoloneAlso: glycyrrhetinic acidone capsule of active or placebo in the evening | Drug | enoxolone, placebo |
Primary outcome
Plasma and urine aldosterone/cortisol ratio
Time frame: Baseline, as predictor for differentiation of treatment groups clinical response
ratio of plasma aldosterone/cortisol at awakening; ratio of nocturnal urine aldosterone concentration/urine cortisol concentration
C-reactive protein
Time frame: Baseline, as predictor for differentiation of treatment groups clinical response and change from baseline (4 weeks)
C-reactive protein in plasma
Systolic blood pressure
Time frame: Baseline, as predictor for differentiation of treatment groups clinical response
Systolic blood pressure at rest at baseline as a predictor for treatment differentiation
Depression rating
Time frame: change from baseline to week 4, with systolic blood pressure as covariate
Hamilton depression rating scale (HAMD) - 17 items; higher is worse
8 secondary outcomes
Urine aldosterone/cortisol ratio
Time frame: change from baseline to week 4
Plasma ratio of sodium/potassium
Time frame: change from baseline to week 4
Nocturnal heart rate variability
Time frame: change from baseline to week 4
Nocturnal blood pressure dip (difference between pre-sleep and minimal nocturnal blood pressure
Time frame: change from baseline to week 4
Depression self rating
Time frame: change from baseline to week 4
Total sleep duration
Time frame: change from baseline to week 4
Salt taste preference and sensitivity
Time frame: change from baseline to week 4
Rating for symptoms of normal pressure hydrocephalus
Time frame: change from baseline to week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 41155634Murck H. Discovery of Personalized Treatment for Immuno-Metabolic Depression-Focus on 11beta Hydroxysteroid Dehydrogenase Type 2 (11betaHSD2) and Toll-like Receptor 4 (TLR4) Inhibition with Enoxolone. Pharmaceuticals (Basel). 2025 Oct 10;18(10):1517. doi: 10.3390/ph18101517.
- Background: PubMed 32306867Murck H, Luerweg B, Hahn J, Braunisch M, Jezova D, Zavorotnyy M, Konrad C, Jansen A, Kircher T. Ventricular volume, white matter alterations and outcome of major depression and their relationship to endocrine parameters - A pilot study. World J Biol Psychiatry. 2021 Feb;22(2):104-118. doi: 10.1080/15622975.2020.1757754. Epub 2020 May 15.
- Background: PubMed 33362613Murck H, Lehr L, Hahn J, Braunisch MC, Jezova D, Zavorotnyy M. Adjunct Therapy With Glycyrrhiza Glabra Rapidly Improves Outcome in Depression-A Pilot Study to Support 11-Beta-Hydroxysteroid Dehydrogenase Type 2 Inhibition as a New Target. Front Psychiatry. 2020 Dec 10;11:605949. doi: 10.3389/fpsyt.2020.605949. eCollection 2020.
- Background: PubMed 34985381Engelmann J, Murck H, Wagner S, Zillich L, Streit F, Herzog DP, Braus DF, Tadic A, Lieb K, Muller MB. Routinely accessible parameters of mineralocorticoid receptor function, depression subtypes and response prediction: a post-hoc analysis from the early medication change trial in major depressive disorder. World J Biol Psychiatry. 2022 Oct;23(8):631-642. doi: 10.1080/15622975.2021.2020334. Epub 2022 Jan 25.
- Background: PubMed 30300165Murck H, Braunisch MC, Konrad C, Jezova D, Kircher T. Markers of mineralocorticoid receptor function: changes over time and relationship to response in patients with major depression. Int Clin Psychopharmacol. 2019 Jan;34(1):18-26. doi: 10.1097/YIC.0000000000000239.
- Individual participant dataSharing planned: Yes. Plan to share study data in concordance with local regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harald Murck, MD PhD study director
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Enoxolone in people with Unipolar Depression, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Schu, MD (+49 6421 5865200, schu@uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and urine aldosterone/cortisol ratio (time frame: Baseline, as predictor for differentiation of treatment groups clinical response). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570110, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.