Stony Brook Medicine Anti-Inflammatory Trial

Sponsor
Stony Brook University
Study ID
NCT06699966
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Nov 21, 2024
Start date
Jun 30, 2027
Status verified
Apr 2026
Primary completion
Jun 30, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Celecoxib Arm
    Participants will take 400mg (two 200mg tablets) of celecoxib daily with a meal for 8 weeks.
  • Experimental: 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 Measure

Change from Baseline Hamilton Depression Rating Scale (HAM-D 24) Score at 8 Weeks [ Time Frame: Baseline and 8 weeks. ]

Central Contacts

Find similar trials

Nationwide
Depression trialsPsychiatry trialsMental health trialsBehavioral health trials

Related Studies