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Dynamics of Inflammation and Its Blockade on Motivational Circuitry in Depression

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ClinicalTrials.gov Identifier: NCT03006393
Recruitment Status : Completed
First Posted : December 30, 2016
Results First Posted : October 19, 2021
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michael Treadway, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Infliximab
Other: Placebo
Enrollment 42
Recruitment Details Participants were enrolled at Emory University in Atlanta, Georgia, USA. Enrollment began in August 2016 and all follow up was complete by September 26, 2020.
Pre-assignment Details  
Arm/Group Title Infliximab Placebo
Hide Arm/Group Description Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period. Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
Period Title: Overall Study
Started 21 21
Completed 20 18
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             1
Pregnancy             0             1
Lost to Follow-up             0             1
Arm/Group Title Infliximab Placebo Total
Hide Arm/Group Description Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period. Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period. Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
40.1  (9.2) 38.0  (7.9) 39.03  (8.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
18
  85.7%
19
  90.5%
37
  88.1%
Male
3
  14.3%
2
   9.5%
5
  11.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Hispanic or Latino
3
  14.3%
2
   9.5%
5
  11.9%
Not Hispanic or Latino
18
  85.7%
18
  85.7%
36
  85.7%
Unknown or Not Reported
0
   0.0%
1
   4.8%
1
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  14.3%
3
   7.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  38.1%
12
  57.1%
20
  47.6%
White
13
  61.9%
5
  23.8%
18
  42.9%
More than one race
0
   0.0%
1
   4.8%
1
   2.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 21 participants 42 participants
21 21 42
1.Primary Outcome
Title Effort-based Decision-making (EBDM) Task Score
Hide Description Reward motivation as assessed by a laboratory effort-based decision-making (EBDM) task administered at Baseline and Day 14. On each trial, participants make a choice about expending more or less physical effort (rapid button pressing) in exchange for varying amounts of monetary rewards. The range of possible values is not fixed. Reported values reflect a model-derived summary statistic for effort discounting behavior, with lower values associated with greater motivation.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants who completed the indicated study visit.
Arm/Group Title Infliximab Placebo
Hide Arm/Group Description:
Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 21 participants 21 participants
2.13  (1.76) 2.09  (1.52)
Day 14 Number Analyzed 20 participants 18 participants
1.85  (1.28) 2.78  (1.70)
2.Secondary Outcome
Title Plasma C-reactive Protein (CRP) Level
Hide Description C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood. CRP level was measured at baseline and Day 14. Lower result correlates with better outcome.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants who completed the indicated study visit and had usable blood samples. Some participants did not complete the trial and another participant had a blood sample of poor quality.
Arm/Group Title Infliximab Placebo
Hide Arm/Group Description:
Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline Number Analyzed 20 participants 21 participants
4.18  (3.28) 7.81  (7.85)
Day 14 Number Analyzed 19 participants 18 participants
2.78  (4.63) 6.35  (6.96)
3.Secondary Outcome
Title Plasma Interleukin-6 (IL-6) Level
Hide Description Plasma IL-6 level will be collected via blood draw. IL-6 level was collected at baseline and Day 14. Lower result correlates with better outcome.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants who completed the indicated study visit and had usable blood samples. Some participants did not complete the trial and another participant had a blood sample of poor quality.
Arm/Group Title Infliximab Placebo
Hide Arm/Group Description:
Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period.
Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: pg/ml
Baseline Number Analyzed 20 participants 21 participants
1.13  (0.96) 1.07  (0.97)
Day 14 Number Analyzed 19 participants 18 participants
0.97  (1.00) 1.19  (1.25)
Time Frame Adverse events were tracked from the time of consent through the 30-Day Post-Infusion Follow-Up Phone Call.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab Placebo
Hide Arm/Group Description Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period. Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period.
All-Cause Mortality
Infliximab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/21 (0.00%)    
Hide Serious Adverse Events
Infliximab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Infliximab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/21 (90.48%)      13/21 (61.90%)    
Ear and labyrinth disorders     
Vertigo *  1/21 (4.76%)  1 0/21 (0.00%)  0
Gastrointestinal disorders     
Heartburn *  2/21 (9.52%)  2 0/21 (0.00%)  0
Bloody stool *  1/21 (4.76%)  1 1/21 (4.76%)  1
Nausea *  2/21 (9.52%)  2 1/21 (4.76%)  1
Stomach ache *  1/21 (4.76%)  1 1/21 (4.76%)  1
General disorders     
Headache *  8/21 (38.10%)  8 8/21 (38.10%)  8
Syncope *  1/21 (4.76%)  1 0/21 (0.00%)  0
Sore throat *  4/21 (19.05%)  4 0/21 (0.00%)  0
Chills *  0/21 (0.00%)  0 1/21 (4.76%)  1
Allergies *  1/21 (4.76%)  1 2/21 (9.52%)  2
Dizziness *  2/21 (9.52%)  2 1/21 (4.76%)  1
Chest pain *  1/21 (4.76%)  1 0/21 (0.00%)  0
Change in blood pressure *  1/21 (4.76%)  1 0/21 (0.00%)  0
Motor vehicle accident *  1/21 (4.76%)  1 1/21 (4.76%)  1
Fatigue *  2/21 (9.52%)  2 0/21 (0.00%)  0
Swelling *  1/21 (4.76%)  1 2/21 (9.52%)  2
Change in appetite *  1/21 (4.76%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in joints *  1/21 (4.76%)  1 0/21 (0.00%)  0
Pain in leg *  1/21 (4.76%)  1 0/21 (0.00%)  0
Muscle tension *  3/21 (14.29%)  3 0/21 (0.00%)  0
Pain in neck *  0/21 (0.00%)  0 1/21 (4.76%)  1
Laceration *  11/21 (52.38%)  0/21 (0.00%)  0
Back pain *  0/21 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders     
Numbness *  1/21 (4.76%)  1 0/21 (0.00%)  0
Migraine *  1/21 (4.76%)  1 0/21 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Pregnancy *  0/21 (0.00%)  0 1/21 (4.76%)  1
Renal and urinary disorders     
Change in urination *  2/21 (9.52%)  2 0/21 (0.00%)  0
Reproductive system and breast disorders     
Menstruation *  1/21 (4.76%)  1 2/21 (9.52%)  2
Skin and subcutaneous tissue disorders     
Itchiness *  2/21 (9.52%)  2 2/21 (9.52%)  2
Vascular disorders     
Bruises *  5/21 (23.81%)  5 5/21 (23.81%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Treadway
Organization: Emory University
Phone: (404) 727-3166
EMail: mtreadway@emory.edu
Layout table for additonal information
Responsible Party: Michael Treadway, Emory University
ClinicalTrials.gov Identifier: NCT03006393    
Other Study ID Numbers: IRB00087941
R01MH108605 ( U.S. NIH Grant/Contract )
First Submitted: December 28, 2016
First Posted: December 30, 2016
Results First Submitted: September 22, 2021
Results First Posted: October 19, 2021
Last Update Posted: October 19, 2021