Treatment of inflammation with Minocycline in depressed patients

Targeting inflammation in depression using minocycline: a patient stratification approach using peripheral inflammatory biomarkers, PET and MRI - RF-2018-12365308

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005162-33-IT

Enrollment

Registered

2023-08-21

Start date

2022-11-08

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressed patients with high levels of inflammation (crp>2 mg/l) and non responder to at least two different antidepressants MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: (R)-[N-metil-11C]PK11195 Product Code: [(R)-N-metil-11CPK11195] Pharmaceutical Form: Solution for injection CAS Number: 205934-46-9 Current Sponsor code: n/a Other descriptive name: N-se

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • presence of major non psychotic depression according to DSM - 5 • crp> 2; • do not respond to two antidepressants; • accept minocycline • no contraindications to minocycline • no contraindications to 11C PK PET Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • drug sensitivity • acute inflammation or autoimmune pathology; • pregnancy or breastfeeding; • suicidal thoughts • hscrp>20 mg/l; • having been exposed to radiotracers within the 7 previous days

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate an improvement in the inflammatory state after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment;Secondary Objective: 1. To evaluate an improvement of the depressive symptoms after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment; 2. To evaluate changes in central inflammation levels (microglia activation) after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment; 3.To evaluate possible brain changes at structural and functional level with MRI after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment; 4. To evaluate possible correlations between observed changes with MRI, microglia activation, peripheral inflammation and improvement of the depressive symptoms;Primary end point(s): improvement of depressive symptomatology;Timepoint(s) of evaluation of this end point: 8 weeks	—

Measure

Time frame

Main Objective: To evaluate an improvement in the inflammatory state after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment;Secondary Objective: 1. To evaluate an improvement of the depressive symptoms after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment; 2. To evaluate changes in central inflammation levels (microglia activation) after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment; 3.To evaluate possible brain changes at structural and functional level with MRI after 8 weeks of treatment with a minocycline in addition to the current antidepressant treatment; 4. To evaluate possible correlations between observed changes with MRI, microglia activation, peripheral inflammation and improvement of the depressive symptoms;Primary end point(s): improvement of depressive symptomatology;Timepoint(s) of evaluation of this end point: 8 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): demonstrate the clinical efficacy of the minocycline in depressed patients not responding stratified on the basis of the inflammation levels;Timepoint(s) of evaluation of this end point: 8 weeks	—

Countries

Italy

Contacts

Public ContactServizio Clinical Trial

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

sct.irrcs@fatebenefratelli.eu0303501503

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026