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Effect of Minocycline on Inflammation in Depressed Patients

NCT06207760 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Minocycline

Minocycline (200 mg/day) for 8 weeks with a single daily administration (2 hard capsules of 100 mg)

Sponsors & Collaborators

  • Ospedale San Raffaele

    collaborator OTHER

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06207760 on ClinicalTrials.gov