Brain Activity, Passiflora Incarnata, Stress, Test Anxiety
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGPascoflair
1 x 2 tablets (single-dose)
OTHERPlacebo
1 x 2 tablets (single-dose)
Sponsors
NeuroCode AG
Pascoe Pharmazeutische Praeparate GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Healthy male and female subjects. * Age between 18 and 40 years (both included). * Anxiety questionnaire PAF (pre-selection of subjects) - values above T\> 60 are regarded as conclusive. * Inconclusive case history and diagnosis. * Subject must be capable of giving informed consent. * Acceptance of written consent to participate in the study after education in written and oral form (informed consent).
Exclusion criteria
* Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. * Clinically relevant pathological findings from clinical and laboratory findings. * Presence of clinically relevant pathological EEG features or artifact-free portion of the screening EEG \<30%. * Clinically relevant allergic symptoms. * Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history. * Detection of drugs (positive drug test) at the time of initial examination (day SC). * Consumption of clinically relevant medication during last fourteen days before and during the active study period based on the notification of the subject or his case history. * Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensives). * Known intolerance / hypersensitivity (allergy) to plant derived extracts (Passion flower dry extract) or any of the ingredients of the investigational product (anamnestic). * Presence of a rare, genetic disease such as fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency (anamnestic). * BMI (Body Mass Index) \<18 or\> 32. * Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day) or tobacco (more than 20 cigarettes per day). * Smoking on day of A.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of verum and placebo Beta 1 power | day A (treatment day) - 1 day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability in a 4- Point scale | Final examination (day AB) -1 day | Tolerability in a 4- Point scale (very good, good, moderately, poor) |
| Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges. | Final examination - 1 day | Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges. |
Outcome results
None listed