Proof of effectiveness of Pascoflair using qantitative measurement of electric brain activity during examination stress in 40 subjects suffering from test anxiety. A double-blind, randomized, placebo-controlled, 2-armed, Phase IV study in parallel design.
Anxiolytic effects of PASCOFLAIR® shall be tested in subjects suffering from test anxiety after single intake by aid of a newly developed, validated method consisting of a combination of eye tracking (following glances) with neurocode tracking (quantitative EEG with a time resolution of 364 ms).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
1 x 2 tablets (single-dose)
1 x 2 tablets (single-dose)
Comparison of verum and placebo Beta 1 power
Comparison of verum and placebo efficacy is performed on electric power in 17 different brain regions within six frequency ranges defined as target parameters in the presence of different stress inducing cognitive tests or exciting video scenes
Time frame: day A (treatment day) - 1 day
Tolerability in a 4- Point scale
Tolerability in a 4- Point scale (very good, good, moderately, poor)
Time frame: Final examination (day AB) -1 day
Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.
Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.
Time frame: Final examination - 1 day
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