Using minocycline to treat obesity and depression with inflammation
Feasibility Study in Comorbid Obesity and Treatment-Resistant Depression Using Minocycline as Adjunctive Treatment (CODA)
This study is trying out minocycline, an anti-inflammatory medication, to see if it can help people with both obesity and depression feel better while they continue their regular antidepressant treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06537921 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and acceptability of using minocycline, an anti-inflammatory medication, in individuals with comorbid obesity and major depressive disorder (MDD) who have elevated inflammation levels. Participants will undergo an 8-week treatment course alongside their regular antidepressant therapy, with assessments including biomarker measurements and participant feedback. The goal is to determine if this approach is viable for future randomized clinical trials targeting this specific population.
Who should consider this trial
Good fit: Ideal candidates are individuals with comorbid obesity, major depressive disorder, and elevated C-reactive protein levels.
Not a fit: Patients with active suicidal ideation or other primary psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new adjunctive therapy for patients suffering from both obesity and treatment-resistant depression.
How similar studies have performed: While the approach of using minocycline for inflammation in depression is emerging, this specific study is novel and aims to establish feasibility before larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sufficient communication skills to understand the intervention and complete the assessments. * Able to give informed consent. * Treatment resistant depressed (i.e., non-responders to current antidepressant treatment, for at least 6-weeks AND at least one other previous antidepressant). * Tolerant to the current antidepressant. * Able to undergo 2 MRI scans. * Accepting augmentation with minocycline. * CRP \>3mg/L at screening. * No plans to change current therapy for the duration of participation. Exclusion Criteria: * Active suicidal ideation. * Current primary diagnosis of psychotic disorder, bipolar disorder, obsessive-compulsive disorder, or post-traumatic stress disorder. * Have an acute infection or an autoimmune disorder, because of both the rare but described association between minocycline and systemic lupus erythematosus, and the potential confounder effects of these conditions on immune biomarkers. * Alcohol misuse disorder or drug addiction. * Neurological disorders (Parkinson's, Alzheimer's). * Current serious cardiovascular problems. * Have acne or psoriasis. * Currently taking any antibiotic, immunosuppressive medication, or warfarin. * Taken any tetracycline within the last month. * Currently taking Lithium or retinoids (Acitretin, Alitretinoin, Isotretinoin). * Refuse that we contact their GP to inform them about their participation. * \[OPTIONAL - if not met, cannot undergo the MRI\] Has any metal implants in their body such as pacemakers, dental fillings, IUD device (if applicable), or had any accidents where metal fragments might have entered the body or eye. * Pregnant or breastfeeding * Have a positive pregnancy test before starting the study/are unwilling to take a pregnancy test and are unwilling to agree to use an acceptable form of contraceptive throughout the study period (e.g., condoms, intrauterine device (IUD)/intrauterine system (IUS), injection, patch, ring). Female participants who use combined oral contraceptives as their main form of birth control will need to use an additional barrier method for the duration of treatment and for 7 days following completion of treatment. * Are currently participating in another Clinical Trial of Investigational Medicinal Product (CTIMP).
Where this trial is running
London
- King's College London — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Valeria Mondelli
- Email: valeria.mondelli@kcl.ac.uk
- Phone: +442078480353
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.