Enoxolone in Major Depression - Biomarker-outcome Relationship

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilipps University Marburg

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.

Eligibility criteria

Qualifiers

Unipolar Depression

in women: Contraceptive means

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Enoxolone

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Philipps University Marburg

Lead sponsor

Slovak Academy of Sciences

Collaborator