Stony Brook Medicine Anti-Inflammatory Trial

ConditionMajor Depressive Disorder

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-65

SponsorStony Brook University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

42 Participants

are divided into 2 treatment groups

Group A: Celecoxib ArmExperimental treatment 1 intervention

Group B: MinocyclineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

Baseline and 8 weeks.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stony Brook University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: