Effect of Minocycline on Inflammation in Depressed Patients

NCT06207760 | Unknown Phase 2

• 1 other identifier: RF-2018-12365308
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Depression

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the peripheral inflammatory status assessed by the measurement of CRP levels and inflammatory markers (i.e. IL-1, IL-6, IL-17 and TNF-alpha)

  To evaluate an improvement in the peripheral inflammatory status in depressed patients after 8 weeks of treatment with Minocycline in addition to their current pharmacological treatment.

  Changes from baseline to week 8

Secondary Outcomes (4)

• Change from baseline in depressive symptoms assessed by HAM-D17

  Changes from baseline to week 8

• Changes from baseline in central inflammatory levels by PET and by assessing differences in PK11195 binding

  Changes from baseline to week 8

• Structural and functional brain changes by MRI

  Changes from baseline to week 8

• Changes from baseline of the associations among brain structure observed with MRI, activation of microglia by PET, peripheral inflammatory markers and depression assessment scales

  Changes from baseline to week 8

Study Arms (1)

Minocycline

EXPERIMENTAL

All subjects will receive Minocycline over 8 weeks in addition to their current antidepressant treatment.

Drug: Minocycline

Interventions

Minocycline DRUG

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

Minocycline

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being male or female depressed patients (aged 25-45);
• Having a current DSM-V diagnosis of non-psychotic major depressive disorder confirmed by SCID;
• Being non-responder to a current SSRI for at least 8 weeks, and historically to one other SSRI;
• Being in stable antidepressant therapy for at least 8 weeks;
• Being tolerant to the current SSRI;
• Accepting Minocycline treatment;
• Having CPR level\> 2 mg/L;
• Having signed and dated an informed consent to participate in the study;
• Having no contraindications to receive treatment with Minocycline;
• Having no contraindications to undergo the 11C-PK PET scan.

You may not qualify if:

• Having active suicidal ideation;
• Having a primary diagnosis of bipolar disorder, obsessive-compulsive disorder, eating disorder, PTSD;
• Having a history of substance/alcohol abuse;
• Having received tetracycline therapy within the previous 2 months;
• Having a history of sensitivity to this class of drugs;
• Having acute infections or an autoimmune or inflammatory disorder;
• Having CRP\>20 mg/L, as indicates acute infection or other major pathology;
• Being sensitive to Minocycline;
• Having a history of severe allergy or hypersensitivity to drugs;
• Being hypersensitive to the active substance, to other tetracyclines or to any of the excipients;
• Having severe renal failure;
• Having hepatic dysfunction;
• Being pregnant and in lactation;
• (for MRI) Having pacemakers, electromechanical devices, ferromagnetic vascular clips, cochlear implants, stapedial prostheses, ferromagnetic foreign bodies, sickle cell anemia;
• Having undergone imaging or treatment procedures using radiopharmaceuticals 7 days prior to the imaging session of this study;

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead
• Ospedale San Raffaele: collaborator

Study Sites (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Lab head of Biological Psichiatry Unit

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 17, 2024
• Study Start: August 28, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

IT (1)