Comorbid Obesity and Depression With an Anti-inflammatory Medication

Launched by KING'S COLLEGE LONDON · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called minocycline, which is usually used as an antibiotic, can help improve symptoms of depression in people who also have obesity and high levels of inflammation. Researchers believe that individuals with a specific level of inflammation in their blood (measured by a substance called C-reactive protein, or CRP) may benefit the most from this treatment. The trial aims to see if minocycline can be a safe and effective option for patients who haven't found relief from other depression medications.

To participate in this study, individuals need to be between the ages of 18 and 75, have been struggling with depression despite trying at least two different antidepressants, and have a CRP level higher than 3 mg/L. Participants will undergo two MRI scans and will need to agree to take minocycline alongside their current depression treatment. Those who have certain mental health disorders, serious medical conditions, or are pregnant or breastfeeding may not be eligible. Throughout the trial, participants will be monitored for their response to the medication and any side effects.

Gender

ALL

Eligibility 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, epilepsy, and autism).
• • Currently taking any antibiotic, immunosuppressive medication, or warfarin.
• • Taken any tetracycline within the previous 2-months.
• • Have hepatic or renal failure.
• • History of cardiovascular problems
• • Refuse that we contact their GP to inform them about their participation in the study.
• • 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 a Clinical Trial of Investigational Medicinal Product (CTIMP).