DepressionPhase 2NCT06207760
Effect of Minocycline on Inflammation in Depressed Patients
A Phase 2 study testing Minocycline in people with Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Depression
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 28 Aug 2023to 30 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
Annamaria Cattaneo, +390303501361, acattaneo@fatebenefratelli.eu
About this study
Official title: Targeting Inflammation in Depression Using Minocycline: a Patient Stratification Approach Using Peripheral Inflammatory Biomarkers, PET and MRI
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.
Read more
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
- Being tested
- Minocycline
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Minocycline (200 mg/day) for 8 weeks with a single daily administration (2 hard capsules of 100 mg)
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | All subjects will receive Minocycline over 8 weeks in addition to their current antidepressant treatment. Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline to week 8
Secondary outcomes (4)
Change from baseline in depressive symptoms assessed by HAM-D17
To assess any improvements in depressive symptoms after 8 weeks of treatment with Minocycline given as adjuvant to the current antidepressant treatment.
Measured: Changes from baseline to week 8
Changes from baseline in central inflammatory levels by PET and by assessing differences in PK11195 binding
To evaluate 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;
Measured: Changes from baseline to week 8
Structural and functional brain changes by MRI
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.
Measured: 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
Identification of correlations between a reduction of peripheral inflammation (by CRP and cytokines levels in blood samples) and/or central inflammatory status (by MRI and PET) and an improvement in depressive symptoms (evaluated by HAM-D17, SCID-5, BDI-II, STAI and CGI scale), after 8 weeks of treatment with Minocycline. Correlations will be calculated by using Pearson or Spearman correlation coefficients (statistical measures to analyse the relationship between variables with different units of measurement).
Measured: Changes from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start28 Aug 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele
- Responsible party
- Principal investigator, Annamaria Cattaneo, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207760
- Sponsor's protocol ID
- RF-2018-12365308
- Status last verified
- Jan 2024
- First submitted
- 27 Nov 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Inflammation in Depression Using Minocycline: a Patient Stratification Approach Using Peripheral Inflammatory Biomarkers, PET and MRI
- ClinicalTrials.gov ID
- NCT06207760
- Acronym / sponsor ID
- RF-2018-12365308
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineAll subjects will receive Minocycline over 8 weeks in addition to their current antidepressant treatment. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineMinocycline (200 mg/day) for 8 weeks with a single daily administration (2 hard capsules of 100 mg) | Drug | Minocycline |
Primary outcome
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)
Time frame: Changes from baseline to week 8
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.
4 secondary outcomes
Change from baseline in depressive symptoms assessed by HAM-D17
Time frame: Changes from baseline to week 8
Changes from baseline in central inflammatory levels by PET and by assessing differences in PK11195 binding
Time frame: Changes from baseline to week 8
Structural and functional brain changes by MRI
Time frame: 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
Time frame: Changes from baseline to week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline in people with Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Changes from baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.