The goal of the current study is to see if there is any link between the amount of inflammation in your body and your ability to respond to anti-depressant medication coupled with an anti-inflammatory medication. Our study doctor believes that people with high levels of inflammation have a harder time getting well. This is an 6 week treatment study for people between 50 and 80 with and without depression. The study is different depending on whether you are currently depressed.
First you should know that participation is completely voluntary, and will involve reviewing your medical records regarding medical and psychiatric diagnoses and medications.
If you are DEPRESSED and participate, you will take an anti-depressant, escitalopram, also known as Lexapro for 6 weeks. Escitalopram is FDA approved and has been on the market since 2002. We are using it in this study, because it is known to have very few side effects. You may also be taking an anti-inflammatory medication called celecoxib, otherwise known as Celebrex or a placebo, which is a sugar pill, in addition to the escitalopram.
In order to measure the amount of inflammation in your body, we will collect some blood and cerebrospinal fluid at the beginning and end of the study. You will also have an MRI and cognitive testing, where you answer questions to help us assess your memory, at the beginning and end of the study. We also have you come in every couple of weeks for brief visits to get more medication and meet with a member of the study team to see how you're doing.
If you are NOT DEPRESSED and participate you will have a blood draw, cerebrospinal fluid collection, an MRI, and cognitive testing, where you answer questions to help us assess your memory at the beginning and end of an 6 week study.
Before participating in the study, the study doctor and team members will be sure to explain the study procedures in more detail and give you time to ask any questions you may have.
If you wish to discuss the study procedures in more depth prior to completing the screening form, please feel free to call us at 215-573-0083 or email cndslab@mail.med.upenn.edu
These questions are voluntary and confidential. Your responses will be stored in a secure online database called REDCAP. Do you consent to completing this screening online and having your responses and contact information stored in REDCAP?
* must provide value
Yes
No
Thank you for showing interest in our study. You have not consented to completing this survey online or having your responses stored in our secure database.
However, if you are still interested in the study and wish to see if you qualify to participate, please call us 215-573-0083 and ask that your screening be completed on paper.
If yes..do you consent to us reviewing your electronic medical records associated with Penn Medicine
* must provide value
Yes
No
N/A- I do not have a medical record with Penn
Date of Birth:
* must provide value
Today M-D-Y
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First name:
* must provide value
Last name:
* must provide value
Primary phone number:
This is a required field. Must be included for survey to be reviewed.
* must provide value
What is the best way to reach you?
Secondary phone number (optional):
What is the best time of day to reach you? You may select more than one option.
Please note that our research team's regular hours are 8:30am - 5:30pm.
Please note that our research team's regular hours are 8:30am - 5:30pm.
How did you hear about our study?
* must provide value
iConnect Flyer/ Brochure Dr. Referral Craigslist VA Radio PATCO Penn Radnor Penn Data Store Social Media (Facebook, Instagram) Other
If you chose referral source option "other" please describe the resource in the space provided.
* must provide value
Male
Female
Transgender
Other
Are you right-handed?
* must provide value
Yes
No
Please note that you must be 18 years or older to participate in our research studies. Participants may be required to provide proof of date of birth (e.g., state issues ID, passport, etc.) during in person screening visit.
If you are under the age of 18 but seeking treatment for depression, please call the University of Pennsylvania's Outpatient Psychiatry Department at 215-746-6700.
Thank you.
Have you been treated for depression in the last 5 years?
Yes
No
What depression treatment have you received in the last 5 years?
Please include therapies and medications (name, start date, and end date/ongoing).
How difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?
Not difficult at all
Somewhat difficult
Very difficult
Extremely difficult
What heart conditions do you have/had?
* must provide value
What breathing problems do you have/had?
* must provide value
What liver or kidney problems do you have/had?
* must provide value
What thyroid or hormone problems do you have/had?
* must provide value
What neurological disorders do you have/had?
* must provide value
What inflammatory disease(s) do you have/had?
* must provide value
What other medical disorder(s) do you have/had?
* must provide value
What psychiatric disorder(s) do you have/had? (including depression, bipolar disorder, anxiety, schizophrenia, etc)
* must provide value
Please provide date of diagnosis
What medication(s) are you allergic or sensitive to?
* must provide value
How many different medications are you CURRENTLY using?
(Please write "NONE" if not currently taking any prescription medications. Please include all prescribed medications for psychiatric or medical purposes, baby aspirin, etc, as best as you can remember. Please do not include over the counter supplements unless you were specifically directed to take by your doctor/medical professional).
* must provide value
Please note that we will need to know the names, dose, and frequency of all of your current medications before you can enroll in the study.
If you do not have dosing and frequency information available, you may bring a list with you to your screening visit.
If you are unsure how to spell the name of your medication, just do your best!
1st medication name:
* must provide value
example: 1 time a day
1st medication start date:
Today M-D-Y approximate start date is acceptable
2nd medication name:
* must provide value
example: 1 time a day
2nd medication start date:
Today M-D-Y approximate start date is acceptable
3rd medication name:
* must provide value
example: 1 time a day
3rd medication start date:
Today M-D-Y approximate start date is acceptable
4th medication name:
* must provide value
example: 1 time a day
4th medication start date:
Today M-D-Y approximate start date is acceptable
5th medication name:
* must provide value
example: 1 time a day
5th medication start date:
Today M-D-Y approximate start date is acceptable
6th medication name:
* must provide value
example: 1 time a day
6th medication start date:
Today M-D-Y approximate start date is acceptable
7th medication name:
* must provide value
example: 1 time a day
7th medication start date:
Today M-D-Y approximate start date is acceptable
8th medication name:
* must provide value
example: 1 time a day
8th medication start date:
Today M-D-Y approximate start date is acceptable
9th medication name:
* must provide value
example: 1 time a day
9th medication start date:
Today M-D-Y approximate start date is acceptable
Have you had any significant past surgeries, major illnesses, or hospitalizations that you have NOT already indicated?
Yes
No
Please describe what significant past surgeries, major illnesses, or hospitalizations you've had.
Have you ever had an MRI before?
Yes
No
Unsure
On what part of your body?
Do you have any metal in your body?
* must provide value
Yes
No
Unsure
Please briefly describe the metal in your body to the best of your ability (i.e., location, type, etc).
Do you have claustrophobia?
* must provide value
Yes
No
Unsure
On average, how often do you drink alcohol per week?
* must provide value
I never drink alcohol Less than once per week 1-2 times per week 3-4 times per week 5-6 times per week Daily
On a typical day that you drink alcohol, how many drinks do you have?
1-2 3-4 5-6 7 or more
Do you smoke or use tobacco?
Yes
No
In the LAST 6 months, have you used any recreational (aka street) drugs or gotten hooked on a prescribed medicine or taken a lot more of it than you were supposed to?
* must provide value
Yes
No
What recreational drugs/prescription medication have you used in the LAST 6 months?
Please mark all that apply.
Marijuana
Cocaine
Stimulants/Uppers (e.g., amphetamine, speed, meth, etc)
Opioids (e.g., heroin, codeine, oxycodone, morphine, etc.)
Hallucinogens (e.g., LSD or acid, mushrooms, MDMA or ecstasy, etc.)
PCP or Ketamine
Sedatives/Downers (e.g., Valium, roofies, Ambien, Ativan, Lunesta, etc.)
Other
How frequently do you use this drug?
Less than once per week 1-2 times per week 3-4 times per week 5-6 times per week Daily
How frequently do you use marijuana?
Less than once per week 1-2 times per week 3-4 times per week 5-6 times per week Daily
How frequently do you use cocaine?
Less than once per week 1-2 times per week 3-4 times per week 5-6 times per week Daily
How frequently do you use stimulants or uppers?
Less than once per week 1-2 times per week 3-4 times per week 5-6 times per week Daily
How frequently do you use opioids?
Less than once per week 1-2 times per week 3-4 times per week 5-6 times per week Daily
How frequently do you use hallucinogens?
Less than once per week 1-2 times per week 3-4 times per week 5-6 times per week Daily
Have you ever been treated for drug or alcohol abuse?
Yes
No
Please briefly describe.
What were you treated for?
When?
Have you used since?
Have you donated blood or plasma in the last 6 weeks?
Yes
No
Do you have any problems with blood draws?
Yes
No
Fear of needles? Difficulties getting blood drawn or fainting? Etc.
What are these problems with blood draws?
What is your height? (In inches)
Inches (Feet x 12 + inches = total inches) 5 ft = 60 inches; 6 ft = 72 inches
What is your approximate weight? (In pounds)
Have you ever participated in research in the past?
Yes
No
Are you currently participating in any other research studies?
Yes
No
Thank you for your interest!
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