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NCT06207760
Effect of Minocycline on Inflammation in Depressed Patients
Phase 2 trial testing Minocycline in Depression in 60 participants. Status unknown.
30 April 2024
Quick facts
| Lead sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 28 August 2023 |
| Primary completion | 30 April 2024 |
| Estimated completion | 30 April 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Minocycline (MINOCYCLINE) — full drug profile →
Conditions studied
- Depression — all drugs for Depression →
Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Who can join
Adults 25 to 45, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06207760
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other IRCCS Centro San Giovanni di Dio Fatebenefratelli trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06207760 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Last refreshed: 17 January 2024
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