DepressionPhase 4S&INCT02389465
Stress and Inflammation in Late-Life Depression
A Phase 4 study testing Escitalopram + Celecoxib in people with Depression and Inflammation, run by University of Pennsylvania at 1 site in United States.
Trial summary
Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that there is a link between depression and inflammatory disease. This study investigates the relationship between inflammation in the brain and depression. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Inflammation
- What is being tested?
- Escitalopram + Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 18 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80, male or female, any race;
- Absence of clinical dementia
- English speaking
- Blood pressure not exceeding 150/90 mmHg, treated or untreated
- Weight greater than 110 lbs
- Normal result on liver-function test
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- No history of ulcer disease or GI bleeding
- No renal insufficiency
- Additional Inclusion Criteria for Depressed Participants:
- DSM-IV criteria for Major Depressive Disorder
- HAM-D greater than 18
Who cannot join
- Known history of relevant severe drug allergy or hypersensitivity (e.g. to Citalopram or Escitalopram, and/or to celecoxib, aspirin, or other NSAIDs only for Phase 2; known demonstration of allergic-type reactions to sulfonamides);
- Does not speak English;
- Cannot give informed consent;
- MRI contraindications (e.g., foreign metallic implants, pacemaker);
- Known primary neurological disorders, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, cognitive impairment or dementia,
- Known severe inflammatory disease such as systemic lupus erythematosis, known autoimmune diseases, such as multiple sclerosis, rheumatoid arthritis; Screen + for RF, ANA, HIV, Hepatitis B or C.
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- Clinical Dementia Rating Scale score greater than 0;
- Diagnosis of a chronic psychiatric illness other than MDD at the discretion of the study doctor;
- Significant handicaps (e.g. uncorrected hearing or visual impairment, mental retardation) that would interfere with testing;
- Bleeding diathesis;
- Severe Medical problem, which in the opinion of the investigator would pose a safety risk to the subject;
- Clinically significant cardiovascular disease that will be assessed on a case-by-case basis. Clinically significant cardiovascular disease usually includes one or more of the following: cardiac surgery or myocardial infarction within the last 4 weeks; unstable angina; acute decompensated congestive heart failure or class IV heart failure; current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope or near syncope; uncontrolled high blood pressure; QTc greater than 450msec (by history for subjects with cardiac disease); documented prior stroke;
- Clinically significant abnormalities on EKG. Primary AV block or Right bundle branch block are not necessarily exclusionary;
- Current diagnosis of cancer
- Current diagnosis of HIV, active Hepatitis B and/or Hepatitis C
- Use of an Investigational medicine within the past 30 days;
- Use of Coumadin, Warfarin within the past 2 months;
- Current treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers, mood stabilizers, antipsychotics, steroids or non-steroidal anti-inflammatory medications or other antidepressants. No subjects will be included in the study unless they have been off all psychotropics for at least 3 weeks, except in the case of fluoxetine, where 5 weeks off treatment will be required;
- Current alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, or current OCD;
- Abnormal liver-function test
- History of ulcer disease, Chron's disease, GI bleeding or anemia
- Weight less than 110 lbs
- Renal insufficiency
- Any other factor that in the investigator's judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from this facility);
- Additional Exclusion Criteria for Depressed Subjects:
- 1) Active suicidality or current suicidal risk as determined by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Stress and Inflammation in the Pathophysiology of Late Life Depression
Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that there is a link between depression and inflammatory disease. This study investigates the relationship between inflammation in the brain and depression. Comparing biological and psychological differences in depressed and non-depressed people allows researchers to find better ways to treat and prevent depression. All participants will have: neuropsychological tests, an EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant coupled with an anti-inflammatory medication or an anti-depressant coupled with a placebo for six weeks. The investigators are trying to correlate brain function with depression levels and biomarkers from the blood and spinal fluid.
- Conditions
- Depression, Inflammation
- Being tested
- Escitalopram + Celecoxib, Escitalopram + Placebo
- Keywords
- Depression, Geriatric, Inflammation
- Medical subject headings
- Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram + CelecoxibDrug
Participants will receive celecoxib in addition to escitalopram
Escitalopram + PlaceboDrug
Participants will receive a placebo in addition to escitalopram.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm is for participants who are not depressed. |
| Experimental - treatment | Experimental | Depressed participants will receive an antidepressant (escitalopram) AND either a non-steroidal anti-inflammatory drug (celecoxib) OR placebo (sugar pill) for 6 weeks. Receives: Drug: Escitalopram + Celecoxib; Drug: Escitalopram + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 Levels
IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.
Measured: up to week 6
Montgomery Asberg Depression Rating Scale (MADRS)
This depression rating scale will be used to determine clinical outcome for depressed participants.
Scores range from 0-60. The higher the score, the worse the outcome (see below)
Normal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60
Measured: Week 6
IL10 Levels
IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startAug 2014
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvette Sheline, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389465
- Sponsor's protocol ID
- 5R01MH098260-02
- Acronym
- S&I
- Status last verified
- Sep 2023
- First submitted
- 27 Feb 2015
- Last updated
- 2 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Luning Prak ET, Brooks T, Makhoul W, Beer JC, Zhao L, Girelli T, Skarke C, Sheline YI. No increase in inflammation in late-life major depression screened to exclude physical illness. Transl Psychiatry. 2022 Mar 24;12(1):118. doi: 10.1038/s41398-022-01883-4.
PubMed 35332134
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Inflammation in the Pathophysiology of Late Life Depression
- ClinicalTrials.gov ID
- NCT02389465
- Acronym / sponsor ID
- S&I / 5R01MH098260-02
- Conditions
- Depression, Inflammation
- Keywords
- Depression, Geriatric, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 2 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that there is a link between depression and inflammatory disease. This study investigates the relationship between inflammation in the brain and depression. Comparing biological and psychological differences in depressed and non-depressed people allows researchers to find better ways to treat and prevent depression. All participants will have: neuropsychological tests, an EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant coupled with an anti-inflammatory medication or an anti-depressant coupled with a placebo for six weeks. The investigators are trying to correlate brain function with depression levels and biomarkers from the blood and spinal fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm is for participants who are not depressed. |
| Experimental - treatment | Experimental | Drug: Escitalopram + Celecoxib, Drug: Escitalopram + PlaceboDepressed participants will receive an antidepressant (escitalopram) AND either a non-steroidal anti-inflammatory drug (celecoxib) OR placebo (sugar pill) for 6 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-80, male or female, any race;
- Absence of clinical dementia
- English speaking
- Blood pressure not exceeding 150/90 mmHg, treated or untreated
- Weight greater than 110 lbs
Key exclusion criteria (26 listed)
- Known history of relevant severe drug allergy or hypersensitivity (e.g. to Citalopram or Escitalopram, and/or to celecoxib, aspirin, or other NSAIDs only for Phase 2; known demonstration of allergic-type reactions to sulfonamides);
- Does not speak English;
- Cannot give informed consent;
- MRI contraindications (e.g., foreign metallic implants, pacemaker);
- Known primary neurological disorders, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, cognitive impairment or dementia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram + CelecoxibParticipants will receive celecoxib in addition to escitalopram | Drug | Experimental - treatment |
| Escitalopram + PlaceboParticipants will receive a placebo in addition to escitalopram. | Drug | Experimental - treatment |
Primary outcome
IL-6 Levels
Time frame: up to week 6
IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Week 6
This depression rating scale will be used to determine clinical outcome for depressed participants. Scores range from 0-60. The higher the score, the worse the outcome (see below) Normal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60
IL10 Levels
Time frame: up to 6 weeks
IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35332134Luning Prak ET, Brooks T, Makhoul W, Beer JC, Zhao L, Girelli T, Skarke C, Sheline YI. No increase in inflammation in late-life major depression screened to exclude physical illness. Transl Psychiatry. 2022 Mar 24;12(1):118. doi: 10.1038/s41398-022-01883-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvette Sheline principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram + Celecoxib in people with Depression and Inflammation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 Levels (time frame: up to week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.