Feasibility Study in Comorbid Obesity and Treatment Resistant Depression using Minocycline as Adjunctive Treatment (CODA) Study
Overview
Are you living with obesity and currently taking antidepressant medication that you feel isn’t really helping?
Researchers at King’s College London are investigating how an anti-inflammatory medication called minocycline can work as an antidepressant in some people with depression – and we need your help.
Scientists have found that the immune system – the body’s system dedicated to fighting infections – is in a state of “hyperactivity” in some patients with depression, despite the lack of any actual ongoing infection. This response is referred to as “inflammation” and this discovery has unveiled unique opportunities to identify new medications to help patients who have also not been responding to their antidepressant medications. What we have yet to understand clearly however, is how an anti-inflammatory medication may have antidepressant effects in the body.
The purpose of this study is to see if adding a course of anti-inflammatory medication (minocycline) alongside a current course of antidepressant treatment on biological inflammation-related pathways in patients with both obesity and depression who are treatment-resistant, selected for increased inflammation levels.
The study will include:
• 8 weeks of treatment with minocycline.
• 4 in-person visits at King’s College Hospital.
• 2 brain scans.
• Blood and saliva sample collections.
To be eligible for the study, you must:
• be aged 18 or older.
• have a current diagnosis of depression.
• have a body mass index equal to 30kg/m2 or higher.
• be currently taking an anti-depressant medication.
• have felt insufficient response to two other anti-depressant medications.
Are you interested in taking part in this study?
Find out more by filling in this form
Planned end date
01 Apr 2027 10:06Conditions
Depression,ObesityInclusion Criteria
• Current diagnosis of MDD.
• BMI ≥30 kg/m2.
• Age 18-65 years inclusive.
• Sufficient communication skills to understand the intervention and complete the assessments.
• Able to give informed consent.
• Non-responders to current antidepressant treatment, for at least 6-weeks.
• 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.
• (Females) Pregnant or breastfeeding
• (Females) 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, IUD/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 CTIMP. For individuals who have been recently on CTIMP clinical trials, inclusion will be decided on case-by-case basis according to the type of trial they have been involved in.