Enoxolone in Major Depression - Biomarker-outcome Relationship

ConditionUnipolar Depression

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Enoxolone
Drug
one capsule of active or placebo in the evening

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: enoxoloneExperimental treatment 1 intervention

Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Plasma and urine aldosterone/cortisol ratio

ratio of plasma aldosterone/cortisol at awakening; ratio of nocturnal urine aldosterone concentration/urine cortisol concentration

Time frame

Baseline, as predictor for differentiation of treatment groups clinical response

C-reactive protein

C-reactive protein in plasma

Time frame

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

Time frame

Baseline, as predictor for differentiation of treatment groups clinical response

Depression rating

Hamilton depression rating scale (HAMD) - 17 items; higher is worse

Time frame

change from baseline to week 4, with systolic blood pressure as covariate

Secondary outcomes

Urine aldosterone/cortisol ratio

Ratio of nocturnal urine aldosterone concentration/urine cortisol concentration

Time frame

change from baseline to week 4

Plasma ratio of sodium/potassium

Ratio of the plasma concentration of sodium/ plasma concentration of potassium

Time frame

change from baseline to week 4

Nocturnal heart rate variability

Average nocturnal heart rate variability, expressed as stress level (Garmin, arbitrary unit)

Time frame

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)

Time frame

change from baseline to week 4

Other outcomes

Lateral cerebral ventricular volume

Volume of lateral ventricles (sum) (mL), measured by MRI with freesurfer program

Time frame

change from baseline to 4 weeks

Corpus callosum volume

Volume of corpus callosum (mL) segments, measured by MRI with freesurfer program

Time frame

change from baseline to 4 weeks

Choroid Plexus Volume

Volume of Choroid Plexi (sum) (mL), measured by MRI with freesurfer program

Time frame

change from baseline to 4 weeks

Saliva cortisol ratio

Ratio of saliva cortisol concentration

Time frame

change from baseline to 4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philipps University Marburg

Lead sponsor

Slovak Academy of Sciences

Collaborator

Source ClinicalTrials.gov

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