TSPO ligands in the treatment of depression: proof-of-concept of efficacy and underlying mechanisms of action

Unipolar/bipolar depressive disorder

ET50 estimated based on the HAMD-21 scores assessed at the baseline and days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment

HAMD-21 score at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment, PHQ-9 score at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment, VAS-scores at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment, BDI-score at baseline and on days 8, 15, 22 and 29 after start of treatment, HAM-A score at baseline and on days 8, 15, 22 and 29 after start of treatment, MADRS score at baseline and on days 1, 2, 3, 4, 5, 6, 7, 8, 15, 22 and 29 after start of the treatment, SSS score at baseline and on days 8, 15, 22 and 29 after start of treatment, C-SSRs score at baseline and on days 8, 15, 22 and 29 after start of treatment, Adverse events on days 1, 8, 15, 22 and 29 after start of treatment, Neurosteroids in serum (pregnenolone, progesterone, 5α-dihydroprogesterone, allopregnanolone, epipregnanolone, pregnanolone, corticosterone, deoxycorticosterone) at baseline and on day 15 after start of treatment, TSPO expression in thrombocytes at baseline and on day 15 after start of treatment, Cortisol Awakening Response (CAR) at baseline and on day 15 after start of treatment measured in saliva directly as well as 30 and 60 minutes after awakening, Cognitive functions assessed with the CANTAB test battery at baseline and on day 15 after start of treatment, Amplitude changes of the blood oxygenation level in fMRI signal (BOLD) during a learning task at baseline and on day 15 and 29 after start of treatment, Representational dissimilarity of emotional stimuli at baseline and on day 15 and 29 after start of treatment, Functional connectivity and connectivity dynamics at baseline and on day 15 and 29 after start of treatment, Alpha diversity (number of species in one habitat) of the microbiome at baseline and on day 15 and 29 after start of treatment, Beta diversity (development of the number of species in one habitat) of the microbiome at baseline and on day 15 and 29 after start of treatment, Odour capacity quantified by the SDI-score at baseline and on day 15 and 29 after start of treatment

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