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Selective Serotonin Reuptake Inhibitor (SSRI) + Nonsteroidal Anti-inflammatory Drug (NSAID)

Escitalopram + Celecoxib for Inflammation (S&I Trial)

Phase 4
Waitlist Available
Led By Yvette Sheline
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absence of clinical dementia
English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights

S&I Trial Summary

This trial is investigating the relationship between inflammation in the brain and depression in adults aged 65 and older.

Eligible Conditions
  • Inflammation
  • Depression

S&I Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are eligible for the study if you are between the ages of 18 and 80, male or female, of any race.
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You are 110 lbs or greater.
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You have a blood pressure of 150/90 mmHg or higher.
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You have no evidence of renal impairment.
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You have no history of ulcer disease or GI bleeding.

S&I Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
IL-6 Levels
IL10 Levels
Montgomery Asberg Depression Rating Scale (MADRS)

Side effects data

From 2022 Phase 4 trial • 119 Patients • NCT02389465
13%
Elevated Blood Pressure
6%
Loss of Libido
6%
Claustophobia
6%
Suicidal Ideation
6%
Headache
6%
Skin Rash
6%
Grinding Teeth
6%
Vasovagal Response
6%
Withdraw Symptoms from Discontinuing Escitalopram Improperly
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram + Celecoxib
Placebo
Escitalopram
Healthy Control

S&I Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental - treatmentExperimental Treatment2 Interventions
Depressed participants will receive an antidepressant (escitalopram) AND either a non-steroidal anti-inflammatory drug (celecoxib) OR placebo (sugar pill) for 6 weeks.
Group II: ControlActive Control1 Intervention
This arm is for participants who are not depressed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram + Placebo
2014
Completed Phase 4
~120
Escitalopram + Celecoxib
2014
Completed Phase 4
~120

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,241 Total Patients Enrolled
13 Trials studying Inflammation
1,481 Patients Enrolled for Inflammation
Yvette ShelinePrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

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

Is the age-qualifying criterion for this trial above or below 25 years of age?

"Patients desiring to join this medical trial must be between 50 and 80 years old."

Answered by AI

Are there any opportunities for individuals to participate in this clinical investigation?

"This research project is no longer recruiting participants. It was initially released on August 1st, 2014 and last updated January 27th, 2022. If you are searching for an alternative trial to join, 1627 studies related to depression are currently enrolling patients while 62 trials concerning the combination of Escitalopram + Celecoxib remain available."

Answered by AI

Are there any requirements for those wishing to enroll in this research study?

"This clinical trial seeks out 150 patients between the ages of 50 and 80 that are suffering from depression."

Answered by AI

What is the current status of Escitalopram in combination with Celecoxib regarding governmental approval?

"The safety of Escitalopram + Celecoxib was rated a 3 due to its status as an approved therapy for medical use - this is classified as Phase 4."

Answered by AI

What is the upper limit of participants for this trial?

"Unfortunately, this trial is not currently accepting new candidates. The last update was on January 27th 2022 and the listing first appeared in August of 2014. Nevertheless, there are 1627 other trials recruiting participants with depression, as well as 62 studies looking for enrollees to research Escitalopram alongside Celecoxib."

Answered by AI

To what purpose is Escitalopram + Celecoxib typically employed?

"Osteoarthritis (OA) is typically managed through the dual prescription of Escitalopram and Celecoxib. This medication combination has also been effective at mitigating anxiety disorders, obsessive-compulsive disorder, as well as acute pain."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Mar 2025