Stony Brook Medicine Anti-Inflammatory Trial

Phase 4

Not yet recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: Celecoxib; Drug: Minocycline

• Registration Number: NCT06699966
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Study Start: 2025-06-30
• Primary Completion: 2027-06-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib Arm	Celecoxib	Participants will take 400mg (two 200mg tablets) of celecoxib daily with a meal for 8 weeks.
Minocycline	Minocycline	Participants will take minocyline for 8 weeks. Dosing of minocycline will gradually increase from 50 mg per day during Week 1, increase to 50 mg b.i.d. during Week 2, and finally reach 100 mg b.i.d. during Weeks 3-8.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Hamilton Depression Rating Scale (HAM-D 24) Score at 8 Weeks	Baseline and 8 weeks.	Participants will have a Hamilton Depression Rating Scale-24 (HDRS) score obtained at baseline. Minimum score 0, maximum possible score 75; the higher the score on the scale, the more severe the degree of depression. After eight weeks of medication treatment, the HDRS score will be reevaluated with the HDRS-24. Participants who have a 50% or greater decrease in their HDRS-24 score will be considered responders (to treatment).