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Nonsteroidal Anti-inflammatory Drug

Celecoxib for Major Depressive Disorder

Phase 4
Recruiting
Led By Christine DeLorenzo, PhD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of MDD and currently in a major depressive episode
Capacity to give informed consent
Must not have
Poor CYP2C9 metabolizer
Currently taking medications that interact with celecoxib (digoxin, antihypertensives, diuretics, anticoagulant or anti-platelet treatment, including aspirin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after 8 weeks of treatment with celecoxib.
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will test whether the anti-inflammatory drug celecoxib can help reduce symptoms of major depressive disorder by reducing neuroinflammation.

Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) currently experiencing a major depressive episode. Participants must score at least 29 on the MADRS, which measures depression severity. People who are pregnant, breastfeeding, or planning to conceive during the study; have certain genetic traits affecting drug metabolism; severe allergies to celecoxib or similar drugs; heart, liver, kidney issues; recent GI bleeding or peptic ulcers can't join.
What is being tested?
The trial tests if Celecoxib (400 mg daily), an anti-inflammatory drug, reduces neuroinflammation and eases symptoms in MDD patients. It involves PET scans using [18F]FEPPA tracer before and after an 8-week treatment period to measure changes in brain inflammation and correlate these with symptom improvement as per HDRS scores.
What are the potential side effects?
Celecoxib may cause digestive system problems like stomach pain and heartburn, allergic reactions such as rashes or swelling, effects on heart health including increased risk of blood clots, stroke or heart attack especially when used long term in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently experiencing a major depressive episode.
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I understand the details of the trial and can consent to participate.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My body processes some medications slowly.
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I am on medications that could interact with celecoxib.
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I do not have any serious illness or neurological issues affecting my brain function.
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My genetic test shows I have low affinity for TSPO.
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I have not had electroconvulsive therapy in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after 8 weeks of treatment with celecoxib.
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 8 weeks of treatment with celecoxib. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in neuroinflammation as measured by [18F]FEPPA PET.
Secondary study objectives
Mental Depression

Side effects data

From 2009 Phase 2 trial • 203 Patients • NCT00964431
12%
Nausea
10%
Post procedural swelling
10%
Alveolar osteitis
10%
Vomiting
8%
Headache
8%
Oropharyngeal pain
4%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indomethacin Test (Upper Dose)
Placebo
Indomethacin Test (Lower Dose)
Celecoxib 400 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Celecoxib 400 mgExperimental Treatment1 Intervention
Patients will receive 400 mg/day of celecoxib for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib 400 mg
2009
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

Brain & Behavior Research FoundationOTHER
62 Previous Clinical Trials
2,879 Total Patients Enrolled
20 Trials studying Depression
1,123 Patients Enrolled for Depression
Stony Brook UniversityLead Sponsor
223 Previous Clinical Trials
41,510 Total Patients Enrolled
16 Trials studying Depression
7,443 Patients Enrolled for Depression
Christine DeLorenzo, PhDPrincipal Investigator - Stony Brook University
Stony Brook University
1 Previous Clinical Trials
85 Total Patients Enrolled
1 Trials studying Depression
85 Patients Enrolled for Depression
~4 spots leftby Jul 2025
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