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

NCT05570110 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	Philipps University Marburg
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	80
Start date	2022-09-23
Completion	2026-06

Conditions

• Unipolar Depression

Interventions

• Enoxolone

Primary outcomes

• Plasma and urine aldosterone/cortisol ratio — 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 — Baseline, as predictor for differentiation of treatment groups clinical response and change from baseline (4 weeks)
  C-reactive protein in plasma
• Systolic blood pressure — 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 — change from baseline to week 4, with systolic blood pressure as covariate
  Hamilton depression rating scale (HAMD) - 17 items; higher is worse

Countries

Germany