Stony Brook Medicine Anti-Inflammatory Trial

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib

Drug

The dose of celecoxib will be at the maximum recommended FDA approved dose (400mg daily). Participants will take two 200mg tablets of celecoxib daily with a meal for 8 weeks.

Other names: Celebrex

Minocycline

Drug

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 outcomes

Change from Baseline Hamilton Depression Rating Scale (HAM-D 24) Score at 8 Weeks

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Christine DeLorenzo, Ph.D.

CONTACT

[email protected]

(631) 638-1523

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start: 2027
Primary completion: 2031
Study completion: 2032
First posted: Nov 21, 2024
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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