Effect of Minocycline on Inflammation in Depressed Patients

Depression Clinical Trial

Official title: Targeting Inflammation in Depression Using Minocycline: a Patient Stratification Approach Using Peripheral Inflammatory Biomarkers, PET and MRI

Status Recruiting

Clinical Trial Summary

The study aims to evaluate or to assess:

• An improvement in the peripheral inflammatory levels in depressed patients after 8 weeks of treatment with Minocycline in addition to their current antidepressant treatment;

• Any improvements in depressive symptoms after 8 weeks of treatment with Minocycline given as adjuvant to the current antidepressant treatment;

• Changes in the inflammatory status in the brain (in terms of microglia activation with 11C PK PET) after 8 weeks of treatment with Minocycline in addition to the current patient's treatment;

• Possible structural and functional brain changes evaluated by MRI after 8 weeks of treatment with Minocycline given as adjuvant to the current patient's treatment;

• Whether changes in MRI, in microglia activation, and peripheral inflammation correlate with the improvement in depressive symptoms.

In order to achieve these, a total of 60 patients, male and female, aged 25-45, who have not responded to their pharmacological treatment and who have medium-high levels of inflammation (with CRP> 2 mg/L) will be included in the study.

Enrolled patients will receive, in addition to their current antidepressant treatment, Minocycline (200 mg/day as total dosage) for 8 weeks.

Patients will be subjected to blood collection and clinical evaluations at baseline and after 8 weeks of treatment with Minocycline.

A subgroup of patients will be subjected to MRI and 11C PK PET assessment at baseline and after 8 weeks of treatment with Minocycline.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Depression
• Inflammation

• NCT number: NCT06207760
• Study type: Interventional
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Status: Recruiting
• Phase: Phase 2
• Start date: August 28, 2023
• Completion date: April 30, 2024