Trial Outcomes & Findings for Stress and Inflammation in Late-Life Depression (NCT NCT02389465)
NCT ID: NCT02389465
Last Updated: 2023-10-02
Results Overview
IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
119 participants
Primary outcome timeframe
up to week 6
Results posted on
2023-10-02
Participant Flow
SEPTA and PATCO advertisements, radio advertisements on WHYY, WMGK, and WURD, Newspaper advertisements in Metro, Milestones, Golden Times, and Haddonfield Sun, recruitment flyers, iConnect, emailing doctors for referrals, and advertising in clinics
Total recruitment was 119 but 24 screen failed so the actual recruitment was 95
Participant milestones
| Measure |
Healthy Control
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Experimental - Placebo
Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study
|
Escitalopram
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
20
|
29
|
16
|
|
Overall Study
COMPLETED
|
29
|
16
|
24
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
5
|
3
|
Reasons for withdrawal
| Measure |
Healthy Control
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Experimental - Placebo
Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study
|
Escitalopram
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Control
n=30 Participants
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Placebo
n=20 Participants
Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study
|
Escitalopram
n=29 Participants
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
n=16 Participants
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=95 Participants
|
|
Age, Customized
18-55
|
10 Participants
n=30 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=29 Participants
|
5 Participants
n=16 Participants
|
26 Participants
n=95 Participants
|
|
Age, Customized
56-65
|
7 Participants
n=30 Participants
|
11 Participants
n=20 Participants
|
13 Participants
n=29 Participants
|
11 Participants
n=16 Participants
|
42 Participants
n=95 Participants
|
|
Age, Customized
66-75
|
10 Participants
n=30 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
22 Participants
n=95 Participants
|
|
Age, Customized
Over 75
|
3 Participants
n=30 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
5 Participants
n=95 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=30 Participants
|
9 Participants
n=20 Participants
|
13 Participants
n=29 Participants
|
9 Participants
n=16 Participants
|
44 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=30 Participants
|
11 Participants
n=20 Participants
|
16 Participants
n=29 Participants
|
7 Participants
n=16 Participants
|
51 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=30 Participants
|
20 Participants
n=20 Participants
|
28 Participants
n=29 Participants
|
16 Participants
n=16 Participants
|
93 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=30 Participants
|
10 Participants
n=20 Participants
|
14 Participants
n=29 Participants
|
5 Participants
n=16 Participants
|
40 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=30 Participants
|
10 Participants
n=20 Participants
|
15 Participants
n=29 Participants
|
11 Participants
n=16 Participants
|
54 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=95 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
1.27 Total score (sum of points)
STANDARD_DEVIATION 1.64 • n=30 Participants
|
25.53 Total score (sum of points)
STANDARD_DEVIATION 5.41 • n=20 Participants
|
27.08 Total score (sum of points)
STANDARD_DEVIATION 5.56 • n=29 Participants
|
26.21 Total score (sum of points)
STANDARD_DEVIATION 4.79 • n=16 Participants
|
20.02 Total score (sum of points)
STANDARD_DEVIATION 1.84 • n=95 Participants
|
|
IL-6 Levels
|
4.89 pg/mL
STANDARD_DEVIATION 3.75 • n=30 Participants
|
13.9 pg/mL
STANDARD_DEVIATION 10.53 • n=20 Participants
|
4.12 pg/mL
STANDARD_DEVIATION 4.05 • n=29 Participants
|
9.18 pg/mL
STANDARD_DEVIATION 10.29 • n=16 Participants
|
8.02 pg/mL
STANDARD_DEVIATION 4.57 • n=95 Participants
|
|
IL-10 Levels
|
4.8 pg/mL
STANDARD_DEVIATION 7.64 • n=30 Participants
|
43.53 pg/mL
STANDARD_DEVIATION 67.4 • n=20 Participants
|
13.93 pg/mL
STANDARD_DEVIATION 39.18 • n=29 Participants
|
17.9 pg/mL
STANDARD_DEVIATION 27.49 • n=16 Participants
|
20.04 pg/mL
STANDARD_DEVIATION 24.98 • n=95 Participants
|
PRIMARY outcome
Timeframe: up to week 6Population: Not everybody completed the final blood draw
IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.
Outcome measures
| Measure |
Healthy Control
n=18 Participants
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Placebo
n=10 Participants
Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study
|
Escitalopram
n=18 Participants
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
n=12 Participants
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
|---|---|---|---|---|
|
IL-6 Levels
|
5.25 pg/mL
Standard Deviation 4.12
|
18.24 pg/mL
Standard Deviation 15.63
|
3.69 pg/mL
Standard Deviation 3.73
|
6.84 pg/mL
Standard Deviation 4.83
|
PRIMARY outcome
Timeframe: Week 6This 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
Outcome measures
| Measure |
Healthy Control
n=23 Participants
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Placebo
n=12 Participants
Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study
|
Escitalopram
n=23 Participants
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
n=12 Participants
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
|---|---|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
1.27 Total Score (Sum of Points)
Standard Deviation 1.64
|
19.14 Total Score (Sum of Points)
Standard Deviation 7.92
|
14.04 Total Score (Sum of Points)
Standard Deviation 9.13
|
12.93 Total Score (Sum of Points)
Standard Deviation 9.59
|
PRIMARY outcome
Timeframe: up to 6 weeksPopulation: Not everybody completed the last blood draw
IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given
Outcome measures
| Measure |
Healthy Control
n=18 Participants
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Placebo
n=10 Participants
Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study
|
Escitalopram
n=18 Participants
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
n=12 Participants
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
|---|---|---|---|---|
|
IL10 Levels
|
4.21 pg/mL
Standard Deviation 5.83
|
64.9 pg/mL
Standard Deviation 82.16
|
12.24 pg/mL
Standard Deviation 29.32
|
18.56 pg/mL
Standard Deviation 28.9
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Escitalopram
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Escitalopram + Celecoxib
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Control
n=30 participants at risk
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Placebo
n=20 participants at risk
Participants meet DSM-IV criteria for MDD, and receieved placebo pills daily for the 6 week duration of the study
Escitalopram + Placebo: Participants will receive a placebo in addition to escitalopram.
|
Escitalopram
n=29 participants at risk
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
n=16 participants at risk
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
|---|---|---|---|---|
|
Cardiac disorders
Elevated Blood Pressure
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
|
General disorders
Dizziness
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Nervous system disorders
Confusion
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Psychiatric disorders
Thoughts of Suicide in Response to Cognitive Task Item
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
Other adverse events
| Measure |
Healthy Control
n=30 participants at risk
Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study
|
Placebo
n=20 participants at risk
Participants meet DSM-IV criteria for MDD, and receieved placebo pills daily for the 6 week duration of the study
Escitalopram + Placebo: Participants will receive a placebo in addition to escitalopram.
|
Escitalopram
n=29 participants at risk
Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.
|
Escitalopram + Celecoxib
n=16 participants at risk
Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study
|
|---|---|---|---|---|
|
Vascular disorders
Vasovagal Response
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
|
General disorders
Headache
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
13.8%
4/29 • Number of events 5 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
|
Nervous system disorders
Dizziness/Light Headed
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
6.9%
2/29 • Number of events 2 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Nervous system disorders
Jittery
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Renal and urinary disorders
Urinating Frequently
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
General disorders
Yawning Frequently
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Psychiatric disorders
Claustophobia
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
|
Reproductive system and breast disorders
Loss of Libido
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 2 • Baseline to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
|
Ear and labyrinth disorders
Grinding Teeth
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
|
Nervous system disorders
More Tired/Lethargy
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
6.9%
2/29 • Number of events 2 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
General disorders
Dry Mouth
|
0.00%
0/30 • Baseline to 6 weeks
|
5.0%
1/20 • Number of events 1 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Psychiatric disorders
Withdraw Symptoms from Discontinuing Escitalopram Improperly
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
6.2%
1/16 • Number of events 1 • Baseline to 6 weeks
|
|
Cardiac disorders
Elevated Blood Pressure
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
12.5%
2/16 • Number of events 2 • Baseline to 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Injury, poisoning and procedural complications
Slipped on Escalator When Leaving Visit
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Surgical and medical procedures
Sore Chest
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Sore Lower Back
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
6.9%
2/29 • Number of events 3 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • Baseline to 6 weeks
|
0.00%
0/20 • Baseline to 6 weeks
|
3.4%
1/29 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
General disorders
Change in Sleep Pattern
|
0.00%
0/30 • Baseline to 6 weeks
|
5.0%
1/20 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
|
Reproductive system and breast disorders
Sexual Side Effect Delayed Ejaculation
|
0.00%
0/30 • Baseline to 6 weeks
|
5.0%
1/20 • Number of events 1 • Baseline to 6 weeks
|
0.00%
0/29 • Baseline to 6 weeks
|
0.00%
0/16 • Baseline to 6 weeks
|
Additional Information
Dr. Yvette Sheline, McLure Professor of Radiology, Neurology and Psychiatry
University of Pennsylvania
Phone: (215) 573-0082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place