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INSTA-MD: INflammation-based Stratification for immune-Targeted Augmentation in Major Depressive disorder
EU CTIS ID: 2022-501692-35-00
What this study is testing
Validate the efficacy of immune-targeted augmentation with minocycline or celecoxib in a Flemish cohort of patients with MDD who failed to remit with one or two trials of antidepressant treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Primary diagnosis of bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use dependence according to DSM-5 (< 4 weeks before screening, excl. nicotine and caffeine)
- Serology positive for hep-B surface antigen, hep-C antibodies or HIV antibodies
- Received ECT < 2 months prior to screening
- The current episode of depression has failed to remit after three trials of antidepressant treatment.
- Blood donation in 30 days prior to screening
- Concomitant penicillin or anticoagulant therapy
See the full eligibility 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 pregnancy tests.
- A score of 14 or higher on the Hamilton Depression Rating scale (HDRS-17)
- Primary diagnosis of bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and/or substance use dependence according to DSM-5 (< 4 weeks before screening, excl. nicotine and caffeine)
- Serology positive for hep-B surface antigen, hep-C antibodies or HIV antibodies
- Received ECT < 2 months prior to screening
- The current episode of depression has failed to remit after three trials of antidepressant treatment.
- Blood donation in 30 days prior to screening
- Concomitant penicillin or anticoagulant therapy
- Pregnancy or breastfeeding
- Being diagnosed with Familial Adenomatous Polyposis (FAP).
- Having an acute infection in the last two weeks, neutrophilia or leukocytosis at screening (i.e. neutrophils ≥ 10 x10^9 /L or white blood cell count ≥ 12 x10^9 /L)
- Currently enrolled in an intervention study
- 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 having an inflammatory bowel disorder.
- Current severe cardiovascular disease (e.g. congestive heart failure (NYHA-class II–IV), ischemic or thrombotic events or unstable coronary artery (incl. coronary artery bypass graft (CABG) surgery))
- Use of (Vitamin K) anticoagulant therapy
- Having received >14 days of tetracycline or NSAID within the previous 2 months, or having a history of sensitivity or intolerance to this classes of drugs
- Chronic severe hypertension (systolic BP > 170 mmHg)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.