INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder

Launched by UNIVERSITEIT ANTWERPEN · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial, called "INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder," is studying new treatment options for people struggling with major depressive disorder (MDD) who haven't responded well to their current antidepressant medication. In this study, participants will randomly receive one of three options: minocycline (an antibiotic that may help with inflammation), celecoxib (a medication usually used for pain and inflammation), or a placebo (a sugar pill with no active ingredients). The goal is to see if these treatments can help improve their depression symptoms.

To participate, individuals must be between 18 and 65 years old, have a confirmed diagnosis of major depressive disorder, and have not seen improvement with their current antidepressant treatment. They should also be in good physical health and able to take medication by mouth. If eligible, participants can expect to take their assigned treatment for the duration of the study while continuing their current antidepressant, and they will be monitored closely by the research team. It's important to note that those with certain medical conditions, other mental health disorders, or who are pregnant or breastfeeding will not be able to participate in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, 18-65 years inclusive.
• • Able and willing to give informed consent and take oral medication.
• • Physically healthy.
• • Diagnosis of Major Depressive Disorder by DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI).
• • The current episode of depression has failed to remit to the current antidepressant treatment at the adequate dose (as defined in the Maudsley Prescribing guidelines). Relapse while taking an antidepressant is also considered a treatment failure.
• • Tolerant to the current antidepressant and having no planned changes in their current therapy for the duration of the study.
• • Stable on current treatment for a minimum of 4 weeks (6 weeks for fluoxetine) prior to baseline.
• • If female and of childbearing age, willing to use adequate contraceptive precautions and willing to take a pregnancy test at baseline.
• Exclusion Criteria:
• • Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (\< 4 weeks before screening, excl. nicotine and caffeine).
• • Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.).
• • History of peptic ulcer disease or gastrointestinal (GI) bleeding.
• • Having an acute infection or inflammatory bowel disorder.
• • Current severe cardiovascular disease, congestive heart failure (NYHA-class II-IV), ischemic or thrombotic events or unstable coronary artery (incl. coronary artery bypass graft (CABG) surgery),
• • Liver impairment (alanine aminotransferase \> 2x upper limit, serum albumin \< 25 g/l or Child-Pugh Score ≥ 10)
• • Renal impairment (creatinine clearance \< 30 mL/min).
• • Having received \>14 days of tetracycline or non-steroidal anti-inflammatory medication within the previous 2 months, or having a history of sensitivity or intolerance to these classes of drugs.
• • Chronic severe hypertension (systolic BP \> 170 mmHg).
• • Serology positive for hepatitis-B surface antigen, hepatitis-C antibodies or HIV antibodies.
• • Received electroconvulsive therapy \< 2 months prior to screening.
• • Blood donation in 30 days prior to screening.
• • Pregnancy or breastfeeding.
• • Currently enrolled in an intervention study.

Trial Officials