Stony Brook Medicine Anti-Inflammatory Trial

NCT06699966 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2024-00259
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Hamilton Depression Rating Scale (HAM-D 24) Score at 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).

  Baseline and 8 weeks.

Study Arms (2)

Celecoxib Arm

EXPERIMENTAL

Participants will take 400mg (two 200mg tablets) of celecoxib daily with a meal for 8 weeks.

Drug: Celecoxib

Minocycline

EXPERIMENTAL

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.

Drug: Minocycline

Interventions

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.

Also known as: Celebrex

Celecoxib Arm

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.

Minocycline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Celecoxib; Minocycline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ramin Parsey, M.D, Ph.D.

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine DeLorenzo, Ph.D.

CONTACT

(631) 638-1523; christine.delorenzo@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator (M.D., Ph.D.)

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: April 23, 2026

Record last verified: 2026-04