ObesityCODANCT06537921
Comorbid Obesity and Depression With an Anti-inflammatory Medication
A study testing Minocycline 200mg in people with Obesity and Major Depressive Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
Research suggests that only a subset of individuals with major depressive disorder (MDD) may benefit from anti-inflammatory treatments: those who have C-reactive protein (CRP) ≥3 mg/L, a commonly used threshold for "low-grade" inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Major Depressive Disorder, Inflammation
- What is being tested?
- Minocycline 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE5 9RT
Melisa Kose, +442078485440, melisa.kose@kcl.ac.uk
Caitlin Pentland, caitlin.pentland@kcl.ac.uk
About this study
Official title: Feasibility Study in Comorbid Obesity and Treatment-Resistant Depression Using Minocycline as Adjunctive Treatment (CODA)
Research suggests that only a subset of individuals with major depressive disorder (MDD) may benefit from anti-inflammatory treatments: those who have C-reactive protein (CRP) ≥3 mg/L, a commonly used threshold for "low-grade" inflammation. The emerging link between metabolic and immune abnormalities in MDD suggests that individuals with comorbid obesity and MDD are a subset of people who could particularly benefit from anti-inflammatory treatment. The coexistence of obesity and MDD has been shown to amplify the risk of clinically elevated CRP levels (≥3mg/L). Therefore, people with comorbid obesity, MDD, and CRP ≥3mg/L could be an ideal target population in future randomised clinical trials (RCTs). However, investigation into the feasibility and acceptability of inflammation-targeting treatment in this population is needed first.
Meta-analyses identify minocycline (a tetracycline antibiotic that can cross the blood-brain barrier) as one of the most effective inflammation-targeting medications with antidepressant effects. Minocycline can safely be used long-term at dosages of up to 200mg per day and has low tendency to lead to antibiotic resistance. A pilot RCT of minocycline found a large effect size (Cohen's d=0.98, p<0.001) for the reduction of MDD symptoms compared with placebo. This effect size was even larger (Cohen's d=1.5, p<0.005) in another RCT using minocycline when considering only participants with CRP ≥3mg/L.
Read more
One mechanism through which minocycline could ameliorate MDD symptoms appears to involve the activation of indoleamine 2,3-dioxygenase (IDO), which leads to an increase in the expression and function of the serotonin transporter. Studies exploring this anti-inflammatory effect in MDD demonstrate that minocycline indeed can inhibit IDO.
Another pathway through which minocycline could ameliorate MDD symptoms is through the reduction of inflammation at the central level. Minocycline has been shown to reduce microglia activation in preclinical models. Previous literature reports an impact of neuroinflammation on white matter microstructure and brain structure in patients with MDD and in individuals with obesity. Minocycline's effect on white matter structure and myelination has not yet been investigated in humans in vivo. Investigating whether neuroimaging biomarker candidates associated with neuroinflammation could be detected in this study design is needed.
Read the detailed description
This is a single-centre feasibility using minocycline (200mg/daily) in participants with comorbid obesity and major depressive disorder (MDD). The study aims to investigate the feasibility and acceptability of this proof-of-concept study in comorbid obesity and depression, selected for elevated inflammation, using adjunctive minocycline treatment.
We will test, in a 12-week feasibility, proof-of-concept study, whether individuals with comorbid obesity and treatment-resistant depression will complete an 8-week course of daily minocycline alongside their regular antidepressant treatment, complete biomarker measurements (e.g., blood, saliva, MRI), and complete other outcome measurements (e.g., questionnaires, interviews). Enrolment and retention rates will be monitored over the 12-week period. The acceptability and suitability of all assessment measures will be examined. Participant feedback of their activities will determine the acceptability of this study, and assist refinement of the design in preparation for a future RCT. The study will also aim to provide insight into the feasibility of using biomarkers of inflammation, as well as pathways affected by minocycline, towards the design of a future RCT in individuals with comorbid obesity and depression.
Objective: Determine the feasibility and acceptability of this protocol in comorbid obesity and depression using minocycline as adjunctive treatment.
Minocycline dosing regimen: After successful completion of the Screening Visit (Visit 1), eligible subjects will be invited for the Baseline (Visit 2) when they will be provided with the first bottle of minocycline (oral capsules) lasting 4 weeks. At the 4-week mark, subjects will return to the clinic to complete Visit 3 and associated visit procedures, including returning the medication bottle and any remaining capsules. Upon returning the bottle, the pharmacy will dispense a second bottle for the subject, once again containing minocycline for 4 weeks. In total, subjects will be taking minocycline for 8 weeks. The dose of 200mg will be taken once daily.
Study schedule:
Following consent, participants will be screened to ensure eligibility according to the inclusion and exclusion criteria as well as a small number of assessments (including safety bloods to check liver and kidney functioning) and questionnaires on mood, medical, and psychiatric history. Furthermore, we will ask each participant's general practitioner (GP) for a summary of the participant's medical records (including current and past medications). For females, a pregnancy test will be done at all visits to ensure that they are not pregnant. A small amount of blood (no more than 10ml, or about 2 teaspoons) will be taken to check your levels of inflammation and some other tests to look at overall health and confirm CRP levels are suitably elevated (at least 3mg/L). If following the screening, participants are deemed eligible, they will be invited for a baseline and then Week 4, Week 8, and Week 12 visits. Simultaneously, eligible participants will be sent a saliva sample collection kit in the post to complete at home and bring with them to their next visit. In this kit will be 6 tubes, saliva collection instructions, and a diary to track your sample collections.
At the Baseline (visit 2) visit, we will repeat some of the questionnaires from the previous visit along with some new questionnaires, including some that ask about past stressful events, how they have been feeling since the last visit, and whether any medications have changed. A sample of blood (no more than 50ml, or 3 tablespoons) will be collected to check inflammation levels. At this visit, participants will also undergo their first brain MRI scan lasting approximately an hour. During this visit, participants will be given their first bottle of minocycline by a study doctor. Participants will take 2 capsules (each 100mg) orally, once a day in the mornings with breakfast, for 28 consecutive days, alongside their usual antidepressant. A diary to track the use of minocycline, any side effects or illness, and any medications taken will be provided too, as well as the 2nd saliva sample collection kit to be completed at home.
At Week 4 (visit 3), after 28 days (±3 days) of taking minocycline, participants will return to the clinic for their next assessment. The assessment and blood collection will be the same as those completed at Baseline. No MRI will be conducted here. Participants will also be given their 2nd bottle of minocycline, dose the same as before, to take for another 28 consecutive days. As before, participants should continue taking their antidepressant normally alongside this and continue completing their diary to track the use of minocycline, any side effects, and any other drugs taken. With these, a saliva sample collection kit will again be provided to complete at home.
At Week 8 (visit 4), after another 28 days (±3 days) of taking minocycline, participants will return for their final in-person visit to the clinic. All assessments, including the MRI, will be the same as those conducted at the Baseline visit. The remaining minocycline will be returned to the research team and no new bottle will be dispensed - this is the end of the minocycline administration.
Finally, at Week 12, participants will be contacted by phone to complete the final set of questionnaires - the same set completed in person at the previous visits. No blood or saliva samples will be collected at this time point.
- Conditions
- Obesity, Major Depressive Disorder, Inflammation
- Being tested
- Minocycline 200mg
- Keywords
- Psychiatry, Immune System, Immunity
- Medical subject headings
- Obesity, Depressive Disorder, Major, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline 200mgDrug
Dosage: 2x100mg/daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Comorbid depression and obesity | Experimental | Participants with comorbid major depressive disorder (MDD) and obesity (BMI≥30 kg/m2) and c-reactive protein (CRP) levels ≥3mg/L at screening. Receives: Drug: Minocycline 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrolment rate
Percentage of participants who consent at the Screening Visit who begin their 8-week course of minocycline.
Measured: Throughout recruitment and screening period
Intervention adherence
Percentage of participants who complete, in full, the 8-week course of minocycline, alongside their usual antidepressant, and the accompanying medication diary. (N=35)
Measured: 8 weeks
Outcome and Biomarker Measurements
Percentage of participants who complete all outcome measurements (i.e., interviews and questionnaires), blood and saliva sample collections (N=35), and all MRI procedures (N=15) at all time points.
Measured: 8 weeks + 12 week follow-up
Effect size calculations
Effect size calculation and power calculation for a range of blood-based and neuroimaging biomarkers changes to inform the design of a future randomised clinical trial (RCT).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Oct 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537921
- Sponsor's protocol ID
- IRAS ID: 333466
- Acronym
- CODA
- Status last verified
- May 2025
- First submitted
- 28 Mar 2024
- Last updated
- 14 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study in Comorbid Obesity and Treatment-Resistant Depression Using Minocycline as Adjunctive Treatment (CODA)
- ClinicalTrials.gov ID
- NCT06537921
- Acronym / sponsor ID
- CODA / IRAS ID: 333466
- Conditions
- Obesity, Major Depressive Disorder, Inflammation
- Keywords
- Psychiatry, Immune System, Immunity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Aug 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.
Research suggests that only a subset of individuals with major depressive disorder (MDD) may benefit from anti-inflammatory treatments: those who have C-reactive protein (CRP) ≥3 mg/L, a commonly used threshold for "low-grade" inflammation. The emerging link between metabolic and immune abnormalities in MDD suggests that individuals with comorbid obesity and MDD are a subset of people who could particularly benefit from anti-inflammatory treatment. The coexistence of obesity and MDD has been shown to amplify the risk of clinically elevated CRP levels (≥3mg/L). Therefore, people with comorbid obesity, MDD, and CRP ≥3mg/L could be an ideal target population in future randomised clinical trials (RCTs). However, investigation into the feasibility and acceptability of inflammation-targeting treatment in this population is needed first.
Meta-analyses identify minocycline (a tetracycline antibiotic that can cross the blood-brain barrier) as one of the most effective inflammation-targeting medications with antidepressant effects. Minocycline can safely be used long-term at dosages of up to 200mg per day and has low tendency to lead to antibiotic resistance. A pilot RCT of minocycline found a large effect size (Cohen's d=0.98, p<0.001) for the reduction of MDD symptoms compared with placebo. This effect size was even larger (Cohen's d=1.5, p<0.005) in another RCT using minocycline when considering only participants with CRP ≥3mg/L.
One mechanism through which minocycline could ameliorate MDD symptoms appears to involve the activation of indoleamine 2,3-dioxygenase (IDO), which leads to an increase in the expression and function of the serotonin transporter. Studies exploring this anti-inflammatory effect in MDD demonstrate that minocycline indeed can inhibit IDO.
Another pathway through which minocycline could ameliorate MDD symptoms is through the reduction of inflammation at the central level. Minocycline has been shown to reduce microglia activation in preclinical models. Previous literature reports an impact of neuroinflammation on white matter microstructure and brain structure in patients with MDD and in individuals with obesity. Minocycline's effect on white matter structure and myelination has not yet been investigated in humans in vivo. Investigating whether neuroimaging biomarker candidates associated with neuroinflammation could be detected in this study design is needed.
Detailed description
This is a single-centre feasibility using minocycline (200mg/daily) in participants with comorbid obesity and major depressive disorder (MDD). The study aims to investigate the feasibility and acceptability of this proof-of-concept study in comorbid obesity and depression, selected for elevated inflammation, using adjunctive minocycline treatment.
We will test, in a 12-week feasibility, proof-of-concept study, whether individuals with comorbid obesity and treatment-resistant depression will complete an 8-week course of daily minocycline alongside their regular antidepressant treatment, complete biomarker measurements (e.g., blood, saliva, MRI), and complete other outcome measurements (e.g., questionnaires, interviews). Enrolment and retention rates will be monitored over the 12-week period. The acceptability and suitability of all assessment measures will be examined. Participant feedback of their activities will determine the acceptability of this study, and assist refinement of the design in preparation for a future RCT. The study will also aim to provide insight into the feasibility of using biomarkers of inflammation, as well as pathways affected by minocycline, towards the design of a future RCT in individuals with comorbid obesity and depression.
Objective: Determine the feasibility and acceptability of this protocol in comorbid obesity and depression using minocycline as adjunctive treatment.
Minocycline dosing regimen: After successful completion of the Screening Visit (Visit 1), eligible subjects will be invited for the Baseline (Visit 2) when they will be provided with the first bottle of minocycline (oral capsules) lasting 4 weeks. At the 4-week mark, subjects will return to the clinic to complete Visit 3 and associated visit procedures, including returning the medication bottle and any remaining capsules. Upon returning the bottle, the pharmacy will dispense a second bottle for the subject, once again containing minocycline for 4 weeks. In total, subjects will be taking minocycline for 8 weeks. The dose of 200mg will be taken once daily.
Study schedule:
Following consent, participants will be screened to ensure eligibility according to the inclusion and exclusion criteria as well as a small number of assessments (including safety bloods to check liver and kidney functioning) and questionnaires on mood, medical, and psychiatric history. Furthermore, we will ask each participant's general practitioner (GP) for a summary of the participant's medical records (including current and past medications). For females, a pregnancy test will be done at all visits to ensure that they are not pregnant. A small amount of blood (no more than 10ml, or about 2 teaspoons) will be taken to check your levels of inflammation and some other tests to look at overall health and confirm CRP levels are suitably elevated (at least 3mg/L). If following the screening, participants are deemed eligible, they will be invited for a baseline and then Week 4, Week 8, and Week 12 visits. Simultaneously, eligible participants will be sent a saliva sample collection kit in the post to complete at home and bring with them to their next visit. In this kit will be 6 tubes, saliva collection instructions, and a diary to track your sample collections.
At the Baseline (visit 2) visit, we will repeat some of the questionnaires from the previous visit along with some new questionnaires, including some that ask about past stressful events, how they have been feeling since the last visit, and whether any medications have changed. A sample of blood (no more than 50ml, or 3 tablespoons) will be collected to check inflammation levels. At this visit, participants will also undergo their first brain MRI scan lasting approximately an hour. During this visit, participants will be given their first bottle of minocycline by a study doctor. Participants will take 2 capsules (each 100mg) orally, once a day in the mornings with breakfast, for 28 consecutive days, alongside their usual antidepressant. A diary to track the use of minocycline, any side effects or illness, and any medications taken will be provided too, as well as the 2nd saliva sample collection kit to be completed at home.
At Week 4 (visit 3), after 28 days (±3 days) of taking minocycline, participants will return to the clinic for their next assessment. The assessment and blood collection will be the same as those completed at Baseline. No MRI will be conducted here. Participants will also be given their 2nd bottle of minocycline, dose the same as before, to take for another 28 consecutive days. As before, participants should continue taking their antidepressant normally alongside this and continue completing their diary to track the use of minocycline, any side effects, and any other drugs taken. With these, a saliva sample collection kit will again be provided to complete at home.
At Week 8 (visit 4), after another 28 days (±3 days) of taking minocycline, participants will return for their final in-person visit to the clinic. All assessments, including the MRI, will be the same as those conducted at the Baseline visit. The remaining minocycline will be returned to the research team and no new bottle will be dispensed - this is the end of the minocycline administration.
Finally, at Week 12, participants will be contacted by phone to complete the final set of questionnaires - the same set completed in person at the previous visits. No blood or saliva samples will be collected at this time point.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility
| Arm | Type | Receives |
|---|---|---|
| Comorbid depression and obesity | Experimental | Drug: Minocycline 200mgParticipants with comorbid major depressive disorder (MDD) and obesity (BMI≥30 kg/m2) and c-reactive protein (CRP) levels ≥3mg/L at screening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
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 |
|---|---|---|
| Minocycline 200mgDosage: 2x100mg/daily for 8 weeks | Drug | Comorbid depression and obesity |
Primary outcome
Enrolment rate
Time frame: Throughout recruitment and screening period
Percentage of participants who consent at the Screening Visit who begin their 8-week course of minocycline.
Intervention adherence
Time frame: 8 weeks
Percentage of participants who complete, in full, the 8-week course of minocycline, alongside their usual antidepressant, and the accompanying medication diary. (N=35)
Outcome and Biomarker Measurements
Time frame: 8 weeks + 12 week follow-up
Percentage of participants who complete all outcome measurements (i.e., interviews and questionnaires), blood and saliva sample collections (N=35), and all MRI procedures (N=15) at all time points.
Effect size calculations
Time frame: 12 weeks
Effect size calculation and power calculation for a range of blood-based and neuroimaging biomarkers changes to inform the design of a future randomised clinical trial (RCT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minocycline 200mg in people with Obesity and Major Depressive Disorder, run by King's College London at 1 site in United Kingdom.
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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 14 Nov 2025. 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 United Kingdom. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeria Mondelli (+442078480353, valeria.mondelli@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrolment rate (time frame: Throughout recruitment and screening period). The study lists 4 primary outcomes in all. 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 14 Nov 2025.