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

NCT05049447 | Completed Phase 4

• 1 other identifier: 200S14PF
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Brain Activity; Passiflora Incarnata; Test Anxiety

Outcome Measures

Primary Outcomes (1)

• Comparison of verum and placebo Beta 1 power

  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

  day A (treatment day) - 1 day

Secondary Outcomes (2)

• Tolerability in a 4- Point scale

  Final examination (day AB) -1 day

• Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.

  Final examination - 1 day

Study Arms (2)

Verum arm

ACTIVE COMPARATOR

Intervention: Drug: Verum (Pascoflair)

Drug: Pascoflair

Placebo arm

PLACEBO COMPARATOR

Intervention: Drug: Placebo

Other: Placebo

Interventions

Pascoflair DRUG

1 x 2 tablets (single-dose)

Verum arm

Placebo OTHER

1 x 2 tablets (single-dose)

Placebo arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead
• NeuroCode AG: collaborator

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 20, 2021
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 20, 2021

Record last verified: 2021-09