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Study of Ibuprofen Effects on Brain Function

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ClinicalTrials.gov Identifier: NCT02507219
Recruitment Status : Completed
First Posted : July 23, 2015
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Major Depressive Disorder
Intervention Drug: Ibuprofen
Enrollment 24
Recruitment Details 24 participants were recruited for the study at the Laureate Institute for Brain Research in Tulsa, Oklahoma.
Pre-assignment Details 22 of 24 participants who signed informed consent were randomized. 2 participants withdrew from the study prior to randomization due to work schedule and no response to scheduling attempts.
Arm/Group Title Placebo, Ibuprofen 200mg, Ibuprofen 600mg Placebo, Ibuprofen, 600mg, Ibuprofen 200mg Ibuprofen, 200mg, Placebo, Ibuprofen 600mg Ibuprofen 200mg, Ibuprofen 600mg, Placebo Ibuprofen 600mg, Placebo, Ibuprofen 200mg Ibuprofen 600mg, Ibuprofen 200mg, Placebo
Hide Arm/Group Description Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Placebo, Ibuprofen 200mg, Ibuprofen 600mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced. Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Placebo, Ibuprofen 600mg, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced. Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 200mg, Placebo, Ibuprofen 600mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced. Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 200mg, Ibuprofen 600mg, Placebo. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced. Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 600mg, Placebo, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced. Subjects will receive one dose of placebo or ibuprofen at three testing sessions in a randomized, double-blind, counter-balanced order. In this arm, the subject will receive the doses in the following order: Ibuprofen 600mg, Placebo, Ibuprofen 200mg. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
Period Title: Overall Study
Started 5 4 3 3 4 3
Completed 4 4 3 3 3 3
Not Completed 1 0 0 0 1 0
Reason Not Completed
Physician Decision             1             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             1             0
Arm/Group Title All Study Participants
Hide Arm/Group Description Subjects received either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter-balanced study. Each participant received all interventions. Each study session occurred 1-2 weeks following the previous session. Ibuprofen was capsuled, and identical placebo capsules were produced.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
The analysis population is based on the 20 participants who completed all 3 arms of the study: placebo, ibuprofen 200mg and 600mg. The 2 participants who entered drug randomization but did not complete the study are not included. The 2 participants who signed informed consent but were not randomized are also not included.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
31.75  (6.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
2
  10.0%
Not Hispanic or Latino
18
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Dose-dependent Differences in the BOLD Response to fMRI Tasks in the Amygdala
Hide Description Change in amygdala activation following administration of placebo, 200mg of ibuprofen or 600mg of ibuprofen
Time Frame 3-6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Scans that had average Euclidean norm of motion parameters less than 0.15 were included in the analyses.
Arm/Group Title Placebo Ibuprofen, 200mg Ibuprofen, 600mg
Hide Arm/Group Description:

Subjects will receive one dose of placebo (sugar pill) at one of the three testing sessions . Placebo capsules will be produced in the same manner as the ibuprofen by a local compounding pharmacy in Tulsa, OK.

Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.

Subjects will receive one oral dose of 200mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.

Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.

Subjects will receive one oral dose of 600mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.

Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.

Overall Number of Participants Analyzed 19 18 19
Mean (Standard Error)
Unit of Measure: percent signal change
Left amygdala 0.20  (0.045) 0.21  (0.032) 0.23  (0.047)
Right amygdala 0.23  (0.037) 0.23  (0.037) 0.17  (0.063)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen, 200mg, Ibuprofen, 600mg
Comments A linear mixed effects model was run for the left amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.000055
Confidence Interval (2-Sided) 95%
-0.00011 to 0.00022
Estimation Comments Slope is percent signal change per milligram of ibuprofen.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen, 200mg, Ibuprofen, 600mg
Comments A linear mixed effects model was run for the right amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.00012
Confidence Interval (2-Sided) 95%
-0.00030 to 0.000067
Estimation Comments Slope is the percent signal change per mg of ibuprofen.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ibuprofen, 200mg Ibuprofen, 600mg
Hide Arm/Group Description

Subjects will receive one dose of placebo (sugar pill) at one of the three testing sessions . Placebo capsules will be produced in the same manner as the ibuprofen by a local compounding pharmacy in Tulsa, OK.

Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.

Subjects will receive one oral dose of 200mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.

Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.

Subjects will receive one oral dose of 600mg at one of the three testing sessions. Ibuprofen capsules will be produced by a local compounding pharmacy in Tulsa, OK.

Ibuprofen: On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.

All-Cause Mortality
Placebo Ibuprofen, 200mg Ibuprofen, 600mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ibuprofen, 200mg Ibuprofen, 600mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ibuprofen, 200mg Ibuprofen, 600mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/21 (0.00%) 
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. Martin Paulus
Organization: Laureate Institute for Brain Research
Phone: 918-502-5120
EMail: mpaulus@laureateinstitute.org
Publications:
Layout table for additonal information
Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT02507219     History of Changes
Other Study ID Numbers: 2015-007-00
First Submitted: July 22, 2015
First Posted: July 23, 2015
Results First Submitted: May 5, 2017
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018