Status:
RECRUITING
Effect of Minocycline on Inflammation in Depressed Patients
Lead Sponsor:
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborating Sponsors:
Ospedale San Raffaele
Conditions:
Depression
Eligibility:
All Genders
25-45 years
Phase:
PHASE2
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 antidepr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- EXCLUSION CRITERIA (FOR ONLY THOSE PATIENTS WHO WILL PERFORM 11C PK PET)
- Having undergone imaging or treatment procedures using radiopharmaceuticals 7 days prior to the imaging session of this study;
- Being unable to complete the 11C PK PET session, according to the clinician;
- Being in current or previous (last two months) treatment with neuroactive drugs (benzodiazepines, barbiturates, picrotoxin and muscimol);
- 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.
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06207760
Start Date
August 28 2023
End Date
April 30 2024
Last Update
January 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125