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New treatment option for Major Depressive Disorder
Official title INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder
ClinicalTrials.gov ID: NCT05644301
What this study is testing
What is Celecoxib?
Celecoxib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.
- Phase 3: a large, late-stage study
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
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...
You likely can't join if
- Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder...
- 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...
- Liver impairment (alanine aminotransferase \> 2x upper limit, serum albumin \< 25 g/l or Child-Pugh Score ≥ 10)
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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duffel, Antwerpen, Belgium
- Brussels, Belgium
- Leuven, Belgium
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 study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duffel, Antwerpen, Belgium; Brussels, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.