This study examines the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD).
This is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial of adjunctive minocycline for patients with unipolar major depressive disorder (MDD). The study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). The respective AD, for which non-response has been documented, must be on a stable regimen for at least 14 days prior to inclusion. AD-ST will then be continued throughout the trial. Trial medication is adjunct oral minocycline 200 mg/day or placebo. Response to treatment will be measured via the Montgomery-Asberg Depression Rating Scale (MADRS). The total study duration for each patient will be 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
168
6 weeks 200mg/day Minocycline add-on
6 weeks Placebo add-on
Heidelberg University Hospital, Department of Psychiatry
Heidelberg, Baden-Wurttemberg, Germany
Department of Psychiatry, Universitiy Hospital
Erlangen, Bavaria, Germany
Department of Psychiatry, LMU Munich
Munich, Bavaria, Germany
Response as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Time frame: 6 weeks
Remission as per MADRS (Montgomery-Åsberg Depression Rating Scale)
Time frame: 6 weeks
HAM-D-17-Scale (17-item Hamilton Depression Rating Scale)
Time frame: 6 weeks
BDI-Scale (Beck Depression Inventory, Self Rating Scale)
Time frame: 6 weeks
CGI-Scale (Clinical Global Impressions Scale)
Time frame: 6 weeks
SCL-90-R (Symptom Checklist 90-R, Self Rating Scale)
Time frame: 6 weeks
Transcriptomic changes in patient-specific peripheral blood-derived monocytic cells
Time frame: 6 weeks
Protein levels of various inflammation-associated markers in patient sera
Time frame: 6 weeks
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Max Planck Institute of Psychiatry
Munich, Bavaria, Germany
Department of Psychiatry, Universitiy Hospital
Regensburg, Bavaria, Germany
Department of Psychiatry, University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital RWTH Aachen
Aachen, Germany
Department of Psychiatry, Charité - Campus Benjamin Franklin
Berlin, Germany
Dept. of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt
Frankfurt, Germany