Trial Outcomes & Findings for Inflammation-Induced CNS Glutamate Changes in Depression (NCT NCT03004443)
NCT ID: NCT03004443
Last Updated: 2023-10-27
Results Overview
Left basal ganglia glutamate was measured by magnetic resonance spectroscopy (MRS). Left basal ganglia glutamate tends to be increased during inflammation and is also associated with an increase in depressive symptoms.
TERMINATED
PHASE4
22 participants
Baseline, Day 3, Week 2
2023-10-27
Participant Flow
Participants were recruited from Emory University Hospitals and Clinics in Atlanta, Georgia, USA. Participant enrollment began May 15, 2017 and the final follow-up assessment occurred November 27, 2019. The study was suspended in March 2020 during the coronavirus disease 2019 (COVID-19) pandemic. Due to the intervention being an immune suppressant it was not safe to reopen the study to enrollment and the decision was made to terminate the study in March 2023.
Participant milestones
| Measure |
Infliximab
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Infliximab
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Inflammation-Induced CNS Glutamate Changes in Depression
Baseline characteristics by cohort
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 3, Week 2Population: Eleven distinct participants in the placebo study arm were examined at least one time point but some had a poor signal scan resulting in non-usable data. One participant in the placebo study arm was removed from the study following the baseline assessment.
Left basal ganglia glutamate was measured by magnetic resonance spectroscopy (MRS). Left basal ganglia glutamate tends to be increased during inflammation and is also associated with an increase in depressive symptoms.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Central Nervous System (CNS) Glutamate
Baseline
|
7.71 mmol/kg
Standard Deviation 0.69
|
6.73 mmol/kg
Standard Deviation 0.64
|
|
Central Nervous System (CNS) Glutamate
Day 3
|
7.19 mmol/kg
Standard Deviation 0.93
|
7.81 mmol/kg
Standard Deviation 0.56
|
|
Central Nervous System (CNS) Glutamate
Week 2
|
7.41 mmol/kg
Standard Deviation 0.74
|
7.17 mmol/kg
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment.
The SHAPS-C is a 14-item, clinician-administered instrument assessing pleasure response/hedonic experience. Responses are scored as 1 = lots of pleasure, 2 = average/usual pleasure, 3 = some pleasure, and 4 = no pleasure. Total scores range from 14 to 56 where higher scores indicate increasing severity of anhedonia.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Snaith-Hamilton Pleasure Scale - Clinician Administered (SHAPS-C) Score
Baseline
|
37.9 score on a scale
Standard Deviation 8.2
|
41.7 score on a scale
Standard Deviation 6.8
|
|
Snaith-Hamilton Pleasure Scale - Clinician Administered (SHAPS-C) Score
Day 3
|
37.2 score on a scale
Standard Deviation 9.4
|
39.1 score on a scale
Standard Deviation 7.8
|
|
Snaith-Hamilton Pleasure Scale - Clinician Administered (SHAPS-C) Score
Week 2
|
32.9 score on a scale
Standard Deviation 10.9
|
41.0 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the infliximab study arm did not complete this assessment at the Day 3 time point. One participant in the placebo study arm was removed from the study following the baseline assessment.
The Mood and Pleasure Scale is an 18-item self-report inventory that was created to disentangle state-wise motivational and consummatory components of everyday activities over a 24-hour period. Responses are given on a 5-point Likert scale where 0 = no pleasure/not at all and 4 = extreme pleasure/very often. Total scores range from 0 to 72 and higher scores indicate greater motivation and pleasure during everyday activities.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Mood and Pleasure Scale - Self Report (MAP-SR) Score
Day 3
|
29.4 score on a scale
Standard Deviation 8.5
|
23.6 score on a scale
Standard Deviation 9.5
|
|
Mood and Pleasure Scale - Self Report (MAP-SR) Score
Baseline
|
29.3 score on a scale
Standard Deviation 3.9
|
23.4 score on a scale
Standard Deviation 11.1
|
|
Mood and Pleasure Scale - Self Report (MAP-SR) Score
Week 2
|
30.8 score on a scale
Standard Deviation 9.6
|
22.6 score on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Some participants did not complete this assessment at the indicated study visits.
The FTT uses a specially adapted tapper that the participant taps as fast as possible using the index finger. The participant is given 5 consecutive 10-second trials for the dominant hands. The finger tapping score is the mean of 5 trials. The FTT is designed to assess subtle motor impairment and is altered in subjects with basal ganglia disorders and lesions. A lower score indicates motor impairment.
Outcome measures
| Measure |
Infliximab
n=10 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=10 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Finger Tapping Task (FTT) Score
Baseline
|
47.0 number of taps
Standard Deviation 7.8
|
42.4 number of taps
Standard Deviation 8.7
|
|
Finger Tapping Task (FTT) Score
Day 3
|
48.4 number of taps
Standard Deviation 7.2
|
46.0 number of taps
Standard Deviation 9.0
|
|
Finger Tapping Task (FTT) Score
Week 2
|
46.1 number of taps
Standard Deviation 5.7
|
46.7 number of taps
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Some participants did not complete this assessment at the indicated study visits.
The DSST is a subtest of the Wechsler Adult Intelligence Scale (WAIS) and consists of rows of blank squares, each printed with a randomly assigned number. The test involves graphomotor speed, visual scanning and memory, with about half of the variance being accounted for by graphomotor speed, a third by visual scanning and 4-5% by memory. Performance on the DSST has been found to correlate with subcortical atrophy in disorders involving basal ganglia.The DSST is scored as the number of correct responses in 120 seconds, with higher scores indicating better performance.
Outcome measures
| Measure |
Infliximab
n=10 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=10 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Digit Symbol Substitution Task (DSST) Score
Baseline
|
55.5 correct responses
Standard Deviation 15.0
|
60.0 correct responses
Standard Deviation 16.6
|
|
Digit Symbol Substitution Task (DSST) Score
Day 3
|
63.8 correct responses
Standard Deviation 16.4
|
67.9 correct responses
Standard Deviation 21.1
|
|
Digit Symbol Substitution Task (DSST) Score
Week 2
|
64.2 correct responses
Standard Deviation 17.4
|
62.9 correct responses
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Some participants did not complete this assessment at the indicated study visits.
The scale measures cognitive processing speed using a series of non-sequentially arranged numbers where the participant is asked to sequentially track the numbers occurring to numerical order as quickly as possible. The score is the time time it takes to complete the task, measured in seconds. A longer time to finish may indicate cognitive impairment.
Outcome measures
| Measure |
Infliximab
n=10 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Trails Making Test A (TMT-A) Score
Baseline
|
28.4 seconds
Standard Deviation 7.6
|
24.9 seconds
Standard Deviation 7.9
|
|
Trails Making Test A (TMT-A) Score
Day 3
|
23.5 seconds
Standard Deviation 8.0
|
22.4 seconds
Standard Deviation 8.2
|
|
Trails Making Test A (TMT-A) Score
Week 2
|
19.4 seconds
Standard Deviation 3.6
|
20.9 seconds
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment.
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure motivation and fatigue, covering the dimensions of General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Participants respond to fatigue related statements using a 5-point scale where 1 = "yes, that is true" and 5 = "no, that is not true". Total scores range from 20 to 100 and higher scores indicate greater fatigue.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Multidimensional Fatigue Inventory (MFI) Score
Baseline
|
77.3 score on a scale
Standard Deviation 11.8
|
75.8 score on a scale
Standard Deviation 11.9
|
|
Multidimensional Fatigue Inventory (MFI) Score
Day 3
|
71.4 score on a scale
Standard Deviation 14.4
|
72.8 score on a scale
Standard Deviation 16.1
|
|
Multidimensional Fatigue Inventory (MFI) Score
Week 2
|
72.3 score on a scale
Standard Deviation 15.1
|
71.6 score on a scale
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment.
The Inventory of Depressive Symptomatology-Self-Report (IDS-SR) is a 30-item self-report instrument designed to measure symptom constructs consistent with current Diagnostic and Statistical Manual of Mental Disorders (DSM) nosology and that has been widely used as a self-report outcome measure of depression. Participants complete 28 of the 30 items, depending on if they experienced an increase or decrease in appetite and weight. Each item is scored on a 4-point scale where 0 means that the symptom is absent and 3 means that the symptom is very strongly felt. Total scores can range between 0 and 84 and higher scores indicate more severe symptoms of depression.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Inventory of Depressive Symptoms-Clinician Rating (IDS-SR) Score
Baseline
|
30.7 score on a scale
Standard Deviation 8.2
|
39.7 score on a scale
Standard Deviation 14.6
|
|
Inventory of Depressive Symptoms-Clinician Rating (IDS-SR) Score
Day 3
|
26.4 score on a scale
Standard Deviation 12.6
|
32.6 score on a scale
Standard Deviation 14.6
|
|
Inventory of Depressive Symptoms-Clinician Rating (IDS-SR) Score
Week 2
|
23.5 score on a scale
Standard Deviation 10.9
|
32.7 score on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. Increases in hsCRP are seen when inflammation is present.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of High-sensitivity C-reactive Protein (Hs-CRP)
Baseline
|
5.70 mg/L
Standard Deviation 5.74
|
5.85 mg/L
Standard Deviation 7.54
|
|
Plasma Concentrations of High-sensitivity C-reactive Protein (Hs-CRP)
Day 3
|
4.74 mg/L
Standard Deviation 5.58
|
6.32 mg/L
Standard Deviation 5.71
|
|
Plasma Concentrations of High-sensitivity C-reactive Protein (Hs-CRP)
Week 2
|
9.02 mg/L
Standard Deviation 14.60
|
4.97 mg/L
Standard Deviation 4.99
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. TNF-α is elevated in patients experiencing inflammation and a decrease in serum TNF-α is an indication of effective treatment.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of Tumor Necrosis Factor Alpha (TNF-α)
Baseline
|
3.78 pg/mL
Standard Deviation 1.45
|
4.50 pg/mL
Standard Deviation 1.75
|
|
Plasma Concentrations of Tumor Necrosis Factor Alpha (TNF-α)
Day 3
|
1.69 pg/mL
Standard Deviation 1.13
|
4.12 pg/mL
Standard Deviation 1.99
|
|
Plasma Concentrations of Tumor Necrosis Factor Alpha (TNF-α)
Week 2
|
2.69 pg/mL
Standard Deviation 1.21
|
4.65 pg/mL
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. TNFR2 has proinflammatory effects and has strong anti-inflammatory activities.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of Tumor Necrosis Factor (TNF) Receptor 2 (TNFR2)
Baseline
|
1610.66 pg/mL
Standard Deviation 647.10
|
1956.91 pg/mL
Standard Deviation 698.70
|
|
Plasma Concentrations of Tumor Necrosis Factor (TNF) Receptor 2 (TNFR2)
Day 3
|
1451.14 pg/mL
Standard Deviation 589.90
|
2028.00 pg/mL
Standard Deviation 774.03
|
|
Plasma Concentrations of Tumor Necrosis Factor (TNF) Receptor 2 (TNFR2)
Week 2
|
1774.36 pg/mL
Standard Deviation 1042.49
|
2049.67 pg/mL
Standard Deviation 814.24
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. IL-1Ra is an anti-inflammatory protein secreted by immune cells, epithelial cells, and adipocytes.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of Interleukin-1 Receptor Antagonist (IL-1Ra)
Baseline
|
463.53 pg/mL
Standard Deviation 171.46
|
394.40 pg/mL
Standard Deviation 174.07
|
|
Plasma Concentrations of Interleukin-1 Receptor Antagonist (IL-1Ra)
Day 3
|
482.49 pg/mL
Standard Deviation 279.85
|
404.43 pg/mL
Standard Deviation 169.55
|
|
Plasma Concentrations of Interleukin-1 Receptor Antagonist (IL-1Ra)
Week 2
|
519.32 pg/mL
Standard Deviation 296.09
|
440.34 pg/mL
Standard Deviation 226.75
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, illness, and in patients with mood disorders. IL-6 is not present or is low in healthy individuals and exact reference ranges vary by lab, with an example normal reference range of 0.31 to 5.00 picograms per milliliter (pg/mL).
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of IL-6
Baseline
|
0.75 pg/mL
Standard Deviation 0.48
|
0.91 pg/mL
Standard Deviation 0.33
|
|
Plasma Concentrations of IL-6
Day 3
|
0.62 pg/mL
Standard Deviation 0.36
|
0.98 pg/mL
Standard Deviation 0.63
|
|
Plasma Concentrations of IL-6
Week 2
|
0.58 pg/mL
Standard Deviation 0.22
|
1.00 pg/mL
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. Working with the pro-inflammatory cytokine IL-6, sIL-6R regulates pro-inflammatory reactions.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of Soluble IL-6 Receptor (sIL-6R)
Baseline
|
30539.70 pg/mL
Standard Deviation 5791.88
|
31108.64 pg/mL
Standard Deviation 8243.70
|
|
Plasma Concentrations of Soluble IL-6 Receptor (sIL-6R)
Day 3
|
32963.18 pg/mL
Standard Deviation 6499.08
|
30732.30 pg/mL
Standard Deviation 7834.47
|
|
Plasma Concentrations of Soluble IL-6 Receptor (sIL-6R)
Week 2
|
31062.73 pg/mL
Standard Deviation 7594.65
|
32156.56 pg/mL
Standard Deviation 7290.96
|
POST_HOC outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. IL-1 Beta is a mediator of the inflammatory response and increased levels are present with a stronger inflammatory stimulus.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of IL-1 Beta
Baseline
|
0.24 pg/mL
Standard Deviation 0.0
|
0.25 pg/mL
Standard Deviation 0.06
|
|
Plasma Concentrations of IL-1 Beta
Day 3
|
0.24 pg/mL
Standard Deviation 0.04
|
0.24 pg/mL
Standard Deviation 0.11
|
|
Plasma Concentrations of IL-1 Beta
Week 2
|
0.25 pg/mL
Standard Deviation 0.06
|
0.48 pg/mL
Standard Deviation 0.68
|
POST_HOC outcome
Timeframe: Baseline, Day 3, Week 2Population: One participant in the placebo study arm was removed from the study following the baseline assessment. Samples were not obtained for one participant in the Infliximab group at Baseline and for one participant in the Placebo group at Week 2.
This study collected blood samples to assess inflammatory markers. Elevated levels of MCP-1 are present with several disease conditions including neuroinflammatory diseases.
Outcome measures
| Measure |
Infliximab
n=11 Participants
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 Participants
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Plasma Concentrations of Monocyte Chemoattractant Protein-1 (MCP-1)
Baseline
|
122.59 pg/mL
Standard Deviation 18.72
|
121.70 pg/mL
Standard Deviation 31.92
|
|
Plasma Concentrations of Monocyte Chemoattractant Protein-1 (MCP-1)
Day 3
|
123.51 pg/mL
Standard Deviation 28.42
|
124.32 pg/mL
Standard Deviation 25.55
|
|
Plasma Concentrations of Monocyte Chemoattractant Protein-1 (MCP-1)
Week 2
|
117.96 pg/mL
Standard Deviation 15.81
|
128.50 pg/mL
Standard Deviation 24.41
|
Adverse Events
Infliximab
Placebo
Serious adverse events
| Measure |
Infliximab
n=11 participants at risk
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 participants at risk
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Product Issues
Serotonin syndrome after study completion and after receiving escitalopram
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
Other adverse events
| Measure |
Infliximab
n=11 participants at risk
Participants randomized to receive one intravenous (IV) infusion of infliximab.
|
Placebo
n=11 participants at risk
Participants will be randomized to receive one intravenous (IV) infusion of placebo.
|
|---|---|---|
|
Surgical and medical procedures
Venipuncture site bruise
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
36.4%
4/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Surgical and medical procedures
Venipuncture stie pain
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
18.2%
2/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Surgical and medical procedures
Infusion site pain
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Surgical and medical procedures
Vascular access failure
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Surgical and medical procedures
Adhesive reaction
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
General disorders
Fatigue
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Musculoskeletal and connective tissue disorders
Shoulder tightness
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
General disorders
Headache
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
18.2%
2/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
General disorders
Lightheadedness
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
General disorders
Dizziness
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
18.2%
2/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Surgical and medical procedures
Puncture site pain
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Musculoskeletal and connective tissue disorders
External ear pain
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Nervous system disorders
Parethesia
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
18.2%
2/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
18.2%
2/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
General disorders
Increased appetite
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
|
Surgical and medical procedures
Infusion site irritation
|
0.00%
0/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
9.1%
1/11 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Week 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place