RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Enoxolone in Major Depression - Biomarker-outcome Relationship

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Unipolar Depression - in women: Contraceptive means Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Enoxolone

one capsule of active or placebo in the evening

Locations (1)

Clinic for Psychiatry and Psychotherapy

Marburg, Hesse, Germany