Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety

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.

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).

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.