Clinical trial NCT05049447: Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress
Brain Activity
Passiflora Incarnata
Test Anxiety
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
Collaborators: name: NeuroCode AG
First posted: 2021-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of verum and placebo Beta 1 power
timeFrame: day A (treatment day) - 1 day
Secondary outcomes:
measure: Tolerability in a 4- Point scale
timeFrame: Final examination (day AB) -1 day
measure: Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.
timeFrame: Final examination - 1 day
Other outcomes:
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