Stony Brook Medicine Anti-Inflammatory Trial

NCT ID: NCT06699966

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2031-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Celecoxib Arm

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

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: 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.

Interventions

Celecoxib

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.

Intervention Type: DRUG

Minocycline

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.

Intervention Type: DRUG

Other Intervention Names

Celebrex

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Ramin Parsey

Principle Investigator (M.D., Ph.D.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramin Parsey, M.D, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Central Contacts

Christine DeLorenzo, Ph.D.

Role: CONTACT

christine.delorenzo@stonybrookmedicine.edu

(631) 638-1523

Other Identifiers

2024-00259

Identifier Type: -

Identifier Source: org_study_id