Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT06699966
Eligibility Criteria:
Inclusion Criteria:
* Current consent form signed
* Capacity to give informed consent
* Age range 18-65 (inclusive)
* Diagnosis of MDD or bipolar depression and currently in a major depressive episode
* Score of at least 29 on the MADRS (at least moderate depression)
Exclusion Criteria:
* Hypersensitivity to celecoxib, minocycline, tetracyclines, sulfonamides, aspirin, other NSAIDs, or any component of the formulation; previous asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
* History of myocardial infarction or current cardiac condition
* Heptic impairment, heart failure, severe renal impairment, recent GI bleed, history of peptic ulcer disease, anemia or any other contraindication for celecoxib or minocycline
* Poor CYP2C9 metabolizer
* Currently taking medications that interact with celecoxib (digoxin, antihypertensives, diuretics, anticoagulant or anti-platelet treatment, including aspirin), or minocycline (isotretinoin, ergot alkaloids) without providing physicians approval
* Use of herbs, drugs, or medications with anti-inflammatory or immunomodulatory properties (within 5 half-lives of starting celecoxib or minocycline treatment)
* Unlikely to tolerate medication washout or the medication-free period following washout.
* Participant considered at significant risk for suicide.
* Electroconvulsive therapy (ECT) within 1 month
* High potential for excessive drug/alcohol use during the treatment period (excluding nicotine or cannabis)
* Significant active physical illness or neurological deficit that may affect brain functioning.
* If participant is currently pregnant, breastfeeding, or planning to conceive during the course of study participation.
* Need for medications that control mania.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06699966
Study Brief:
Protocol Section:
NCT06699966