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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Collaborator: NeuroCode AG

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.