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

NCT ID: NCT05049447

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-08-31

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).

Conditions

Stress; Brain Activity; Passiflora Incarnata; Test Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verum arm

Intervention: Drug: Verum (Pascoflair)

Group Type: ACTIVE_COMPARATOR

Pascoflair

Intervention Type: DRUG

1 x 2 tablets (single-dose)

Placebo arm

Intervention: Drug: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

1 x 2 tablets (single-dose)

Interventions

Pascoflair

1 x 2 tablets (single-dose)

Intervention Type: DRUG

Placebo

1 x 2 tablets (single-dose)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroCode AG

UNKNOWN

Sponsor Role: collaborator

Pascoe Pharmazeutische Praeparate GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

200S14PF

Identifier Type: -

Identifier Source: org_study_id