Trial Outcomes & Findings for PharmacofMRI of Anxiolytic Medications (Pregabalin) (NCT NCT00706836)
NCT ID: NCT00706836
Last Updated: 2019-04-09
Results Overview
Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.
COMPLETED
PHASE4
16 participants
Week 1, 2, 3 (Cross-over Design)
2019-04-09
Participant Flow
Healthy subjects recruited by posted advertisements.
Subjects determined to be healthy based on physical examination, mental health examination, and routine bloodwork.
Participant milestones
| Measure |
All Study Participants
Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo
All participants received all 3 treatments on different days.
Sequence not available.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PharmacofMRI of Anxiolytic Medications (Pregabalin)
Baseline characteristics by cohort
| Measure |
All 3 Treatments (Cross-Over Design)
n=16 Participants
Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo
All subjects received all 3 treatments on different days.
Sequence data not available.
|
|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1, 2, 3 (Cross-over Design)Population: Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order.
Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.
Outcome measures
| Measure |
Pregabalin Low Dose (Crossover)
n=16 Participants
Pregabalin oral tablets (50 mg)
pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
|
Pregabalin High Dose (Crossover)
n=16 Participants
Pregabalin oral tablets (200 mg)
pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
|
Placebo (Crossover)
n=16 Participants
Placebo
placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan
|
|---|---|---|---|
|
Effect of Pregabalin (Two Doses) Versus Placebo
|
0.6 % signal change L amygdala + anticipn
Standard Error 0.2
|
-0.1 % signal change L amygdala + anticipn
Standard Error 0.1
|
0.6 % signal change L amygdala + anticipn
Standard Error 0.2
|
Adverse Events
Pregabalin Low Dose (Crossover)
Pregabalin High Dose (Crossover)
Placebo (Crossover)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregabalin Low Dose (Crossover)
n=16 participants at risk
Pregabalin oral tablets (50 mg)
pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan
|
Pregabalin High Dose (Crossover)
n=16 participants at risk
Pregabalin oral tablets (200 mg)
pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan
|
Placebo (Crossover)
n=16 participants at risk
Placebo
placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Acute within 2 hours of administration
Single dose acute adverse events
|
25.0%
4/16 • Number of events 4 • Acute within 2 hours of administration
Single dose acute adverse events
|
0.00%
0/16 • Acute within 2 hours of administration
Single dose acute adverse events
|
Additional Information
Murray B. Stein MD, MPH
University of California San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place