Minocycline treatment for inflammation in depressed patients
Targeting Inflammation in Depression Using Minocycline: a Patient Stratification Approach Using Peripheral Inflammatory Biomarkers, PET and MRI
This study is testing if adding Minocycline to the usual antidepressant treatment can help people aged 25-45 with depression who haven't felt better with their current medication by looking at inflammation in the body and brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 1 site (Brescia) |
| Trial ID | NCT06207760 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of Minocycline on inflammation and depressive symptoms in patients aged 25-45 who have not responded to their current antidepressant treatment. Over 8 weeks, participants will receive Minocycline in addition to their existing SSRI therapy, with assessments of peripheral inflammatory levels, brain inflammation via microglia activation, and structural and functional brain changes using MRI. The study aims to correlate these changes with improvements in depressive symptoms, providing insights into the inflammatory aspects of depression.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 25-45 with non-psychotic major depressive disorder who have not responded to at least two SSRIs.
Not a fit: Patients with active suicidal ideation or primary diagnoses of bipolar disorder, OCD, eating disorders, or PTSD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new approach to managing depression by targeting inflammation.
How similar studies have performed: While the approach of using Minocycline for depression is relatively novel, there is emerging evidence suggesting that targeting inflammation may improve depressive symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Being male or female depressed patients (aged 25-45);
2. Having a current DSM-V diagnosis of non-psychotic major depressive disorder confirmed by SCID;
3. Being non-responder to a current SSRI for at least 8 weeks, and historically to one other SSRI;
4. Being in stable antidepressant therapy for at least 8 weeks;
5. Being tolerant to the current SSRI;
6. Accepting Minocycline treatment;
7. Having CPR level\> 2 mg/L;
8. Having signed and dated an informed consent to participate in the study;
9. Having no contraindications to receive treatment with Minocycline;
10. Having no contraindications to undergo the 11C-PK PET scan.
Exclusion Criteria:
1. Having active suicidal ideation;
2. Having a primary diagnosis of bipolar disorder, obsessive-compulsive disorder, eating disorder, PTSD;
3. Having a history of substance/alcohol abuse;
4. Having received tetracycline therapy within the previous 2 months;
5. Having a history of sensitivity to this class of drugs;
6. Having acute infections or an autoimmune or inflammatory disorder;
7. Having CRP\>20 mg/L, as indicates acute infection or other major pathology;
8. Being sensitive to Minocycline;
9. Having a history of severe allergy or hypersensitivity to drugs;
10. Being hypersensitive to the active substance, to other tetracyclines or to any of the excipients;
11. Having severe renal failure;
12. Having hepatic dysfunction;
13. Being pregnant and in lactation;
14. (for MRI) Having pacemakers, electromechanical devices, ferromagnetic vascular clips, cochlear implants, stapedial prostheses, ferromagnetic foreign bodies, sickle cell anemia;
EXCLUSION CRITERIA (FOR ONLY THOSE PATIENTS WHO WILL PERFORM 11C PK PET)
15. Having undergone imaging or treatment procedures using radiopharmaceuticals 7 days prior to the imaging session of this study;
16. Being unable to complete the 11C PK PET session, according to the clinician;
17. Being in current or previous (last two months) treatment with neuroactive drugs (benzodiazepines, barbiturates, picrotoxin and muscimol);
18. Being women of childbearing potential who are not surgically sterile and who do not guarantee to abstain from sexual activity for the 24 hours following the administration of 11C PK PET.
Where this trial is running
Brescia
- IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.