Minocycline hydrochloride for Major depressive disorder

Inclusion criteria

• {"criterion_text":"- 1.\tBeing male or female depressed patients (aged 18-65);"}
• {"criterion_text":"- 2.\tHaving a current DSM-V diagnosis of nonpsychotic major depressive disorder confirmed by SCID;"}
• {"criterion_text":"- 3.\tBeing non-responder to a current SSRI for at least 8 weeks, and historically to one other SSRI;"}
• {"criterion_text":"- 4.\tBeing in stable antidepressant therapy for at least 8 weeks;"}
• {"criterion_text":"- 5.\tBeing tolerant to the current SSRI;"}
• {"criterion_text":"- 6.\tAccepting Minocycline treatment;"}
• {"criterion_text":"- 7.\tHaving CPR level> 2 mg/L;"}
• {"criterion_text":"- 8.\tHaving signed and dated an informed consent to participate in the study;"}
• {"criterion_text":"- 9.\tHaving no contraindications to receive treatment with Minocycline."}

Exclusion criteria

• {"criterion_text":"- 1.\tHaving active suicidal ideation;"}
• {"criterion_text":"- 2.\tHaving a primary diagnosis of bipolar disorder, obsessive-compulsive disorder, eating disorder, PTSD;"}
• {"criterion_text":"- 3.\tHaving a history of substance/alcohol abuse;"}
• {"criterion_text":"- 4.\tHaving received tetracycline therapy within the previous 2 months;"}
• {"criterion_text":"- 5.\tHaving a history of sensitivity to this class of drugs;"}
• {"criterion_text":"- 6.\tHaving acute infections or an autoimmune or inflammatory disorder;"}
• {"criterion_text":"- 7.\tHaving CRP>20 mg/L, as indicates acute infection or other major pathology;"}
• {"criterion_text":"- 8.\tBeing sensitive to Minocycline;"}
• {"criterion_text":"- 9.\tHaving a history of severe allergy or hypersensitivity to drugs;"}
• {"criterion_text":"- 10.\tBeing hypersensitive to the active substance, to other tetracyclines or to any of the excipients;"}
• {"criterion_text":"- 11.\tHaving severe renal failure;"}
• {"criterion_text":"- 12.\tHaving hepatic dysfunction;"}
• {"criterion_text":"- 13.\tBeing pregnant and in lactation;"}
• {"criterion_text":"- 14.\t(for MRI) Having pacemakers, electromechanical devices, ferromagnetic vascular clips, cochlear implants, stapedial prostheses, ferromagnetic foreign bodies, sickle cell anemia."}

Primary endpoints

• {"endpoint_text":"- Changes in the levels of peripheral inflammatory biomarkers in depressed patients before and after 8 weeks of treatment with Minocycline.","definition_or_measurement_approach":"Change in levels of peripheral inflammatory biomarkers measured in peripheral blood before and after 8 weeks of treatment with Minocycline."}

Secondary endpoints

• {"endpoint_text":"- Changes in depressive symptoms in depressed patients before and after 8 weeks of treatment with Minocycline","definition_or_measurement_approach":"Assessment of changes in depressive symptoms before and after 8 weeks of treatment (measurement instrument not specified in the available data)."}
• {"endpoint_text":"- Structural and functional brain changes before and after 8 weeks of treatment with Minocycline","definition_or_measurement_approach":"Assessment of structural and functional brain changes by MRI before and after 8 weeks of treatment."}
• {"endpoint_text":"- Associations among changes in MRI, peripheral inflammation and any improvement in depressive symptoms","definition_or_measurement_approach":"Correlation analyses between MRI changes, peripheral inflammatory biomarker changes and changes in depressive symptoms (specific methods not specified)."}
• {"endpoint_text":"- Changes in depressive symptoms and in the levels of peripheral pro-inflammatory cytokines at 12 and 32 weeks from baseline, such as 4 and 24 weeks after completing the 8-week treatment period;","definition_or_measurement_approach":"Assessment of depressive symptoms and peripheral pro-inflammatory cytokine levels at 12 and 32 weeks from baseline (timing specified; measurement instruments not specified)."}

Italy

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

04-02-2026

Processing Time Days

385

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy