Effect of Minocycline on Inflammation in Depressed Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2025-02-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Institutional Founds of IRCCS Centro San Giovanni di Dio Fatebenefratelli

External identifiers

EU CT number

2024-520076-10-01

EudraCT number

2020-005162-33

ClinicalTrials.gov

NCT06207760

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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

Secondary objectives 1

1. To assess any improvements in depressive symptoms after 8 weeks of treatment with Minocycline given as adjuvant to the current antidepressant treatment; • To evaluate the long-term effects of Minocycline on depressive symptoms and inflammatory status at 12 and 32 weeks from the baseline, such as 4 and 24 weeks after completing the 8-week treatment period; • To evaluate by MRI possible structural and functional brain changes after 8 weeks of treatment with Minocycline given as adjuvant to the current patient’s treatment; • To evaluate whether changes in MRI and in peripheral inflammation correlate with the improvement in depressive symptoms.

Conditions and MedDRA coding

Depression

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Being male or female depressed patients (aged 18-65); 2. Having a current DSM-V diagnosis of nonpsychotic 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.

Exclusion criteria 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Changes in the levels of peripheral inflammatory biomarkers in depressed patients before and after 8 weeks of treatment with Minocycline.

Secondary endpoints 4

1. Changes in depressive symptoms in depressed patients before and after 8 weeks of treatment with Minocycline
2. Structural and functional brain changes before and after 8 weeks of treatment with Minocycline
3. Associations among changes in MRI, peripheral inflammation and any improvement in depressive symptoms
4. Changes in depressive symptoms and in the levels of peripheral pro-inflammatory cytokines at 12 and 32 weeks from baseline, such as 4 and 24 weeks after completing the 8-week treatment period;

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli

Sponsor organisation

Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli

Address

Via Pilastroni 4

City

Brescia

Postcode

25125

Country

Italy

Scientific contact point

Organisation

Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli

Contact name

Annamaria Cattaneo

Public contact point

Organisation

Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli

Contact name

Annamaria Cattaneo

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications