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Enoxolone in Major Depression - Biomarker-outcome Relationship

StatusRecruiting
PhasePhase 1/2
Started
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Record status
This record was last updated December 8, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Mar 2025 to Jun 2026v4 Show 5 more changesShow less
    • Primary endpoints revised (4)
    • Enrollment target: 60 to 80
    • Secondary endpoints: 9 to 8
    • Study description expanded, about 13 words
    • Publications revised (5)
  2. Re-verified, no change to tracked fieldsv3
  3. Primary endpoints: 13 to 4
    • Secondary endpoints: 10 to 9
    • Study description expanded, about 61 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05570110
Lead Sponsor Philipps University Marburg
Collaborators: Slovak Academy of Sciences
Conditions
(from sponsor)		 Unipolar Depression
Related terms Depressive Disorder
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov