Trial Outcomes & Findings for Study of Ibuprofen Effects on Brain Function (NCT NCT02507219)
NCT ID: NCT02507219
Last Updated: 2018-02-23
Results Overview
Change in amygdala activation following administration of placebo, 200mg of ibuprofen or 600mg of ibuprofen
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
24 participants
Primary outcome timeframe
3-6 weeks
Results posted on
2018-02-23
Participant Flow
24 participants were recruited for the study at the Laureate Institute for Brain Research in Tulsa, Oklahoma.
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.
Participant milestones
| Measure |
Placebo, Ibuprofen 200mg, Ibuprofen 600mg
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.
|
Placebo, Ibuprofen, 600mg, Ibuprofen 200mg
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.
|
Ibuprofen, 200mg, Placebo, Ibuprofen 600mg
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.
|
Ibuprofen 200mg, Ibuprofen 600mg, Placebo
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.
|
Ibuprofen 600mg, Placebo, Ibuprofen 200mg
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.
|
Ibuprofen 600mg, Ibuprofen 200mg, Placebo
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
3
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
4
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo, Ibuprofen 200mg, Ibuprofen 600mg
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.
|
Placebo, Ibuprofen, 600mg, Ibuprofen 200mg
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.
|
Ibuprofen, 200mg, Placebo, Ibuprofen 600mg
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.
|
Ibuprofen 200mg, Ibuprofen 600mg, Placebo
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.
|
Ibuprofen 600mg, Placebo, Ibuprofen 200mg
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.
|
Ibuprofen 600mg, Ibuprofen 200mg, Placebo
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Ibuprofen Effects on Brain Function
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.75 Years
STANDARD_DEVIATION 6.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-6 weeksPopulation: Scans that had average Euclidean norm of motion parameters less than 0.15 were included in the analyses.
Change in amygdala activation following administration of placebo, 200mg of ibuprofen or 600mg of ibuprofen
Outcome measures
| Measure |
Placebo
n=19 Participants
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.
|
Ibuprofen, 200mg
n=18 Participants
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.
|
Ibuprofen, 600mg
n=19 Participants
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.
|
|---|---|---|---|
|
Dose-dependent Differences in the BOLD Response to fMRI Tasks in the Amygdala
Left amygdala
|
0.20 percent signal change
Standard Error 0.045
|
0.21 percent signal change
Standard Error 0.032
|
0.23 percent signal change
Standard Error 0.047
|
|
Dose-dependent Differences in the BOLD Response to fMRI Tasks in the Amygdala
Right amygdala
|
0.23 percent signal change
Standard Error 0.037
|
0.23 percent signal change
Standard Error 0.037
|
0.17 percent signal change
Standard Error 0.063
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen, 200mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen, 600mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Martin Paulus
Laureate Institute for Brain Research
Phone: 918-502-5120
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place