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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after 8 weeks of treatment with celecoxib.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in neuroinflammation as measured by [18F]FEPPA PET.
Secondary outcome measures
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

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
61 Previous Clinical Trials
2,772 Total Patients Enrolled
19 Trials studying Depression
1,093 Patients Enrolled for Depression
Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,485 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to participate in this research project?

"With the goal of including 42 participants in total, this medical trial seeks individuals who are between 18 and 65 years old, possess a MADRS score of 29 or higher and have an existing diagnosis of neuroinflammation."

Answered by AI

What are the normal indications for administering Celecoxib 400 mg?

"Celecoxib 400 mg is a proven remedy for pain, as well as primary dysmenorrhoea, rheumatoid arthritis and ankylosing spondylitis."

Answered by AI

How many participants are being observed for this research experiment?

"Affirmative. On clinicaltrials.gov, the listing for this study states that recruitment is currently underway. Originally uploaded on August 1st 2018 and most recently updated October 24th 2022, 42 patients must be enrolled from a single locale."

Answered by AI

What safety risks are associated with a dosage of Celecoxib 400 mg?

"The safety of Celecoxib 400 mg has been validated by Phase 4 trials, and as such receives a score of 3 on our scale."

Answered by AI

Does this research trial accept participants who are over 55 years old?

"Patients must meet two age criteria in order to be considered for the clinical trial: they should not be younger than 18 years old, nor older than 65."

Answered by AI

Is participation in this clinical trial still available?

"Affirmative, clinicaltrials.gov verifies that this trial is recruiting participants as of now. Initially posted on August 1st 2018, the study was last amended on October 24th 2022 and still requires 42 volunteers from a single medical centre to complete it."

Answered by AI

Who else is applying?

What site did they apply to?
Psychiatry Department at Stony Brook University
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have tried a number of medications that have not helped me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Effect of Celecoxib on Neuroinflammation in MDD
Christine DeLorenzo 2018. "The Effect of Celecoxib on Neuroinflammation in MDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04814355.
All > Mdd
~2 spots leftby Jul 2024
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