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NCT06699966 | NOT YET RECRUITING | Major Depressive Disorder

Stony Brook Medicine Anti-Inflammatory Trial
Sponsor:

Stony Brook University

Information provided by (Responsible Party):

Parsey of Ram

Brief Summary:

This is an experimental study designed to measure the effect of celecoxib or minocycline on depressive symptoms in unipolar and bipolar depression. Participants will be equally randomized to either celecoxib or minocycline. All participants will complete a battery of clinical and psychological assessments prior to treatment assignment, and again after treatment completion, to assess any changes or improvements in depression.

Condition or disease

Major Depressive Disorder

Intervention/treatment

Celecoxib

Minocycline

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 42 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Stony Brook Medicine Anti-Inflammatory Trial
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2027-06-30
Estimated Study Completion Date : 2028-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Stony Brook Medicine Anti-Inflammatory Trial

Location Details

NCT06699966

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