A Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress

A Pilot Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress Assessed Under Laboratory Conditions And In Everyday Life

A pilot investigation into the stress relieving properties of Vitano® which will assess the following hypotheses

Individuals exposed to Vitano® will demonstrate diminished blood pressure and heart rate responses to mental stress compared to individuals in the control condition

Physiological recovery (BP, HR and cortisol) from mental stress will be enhanced in individuals exposed to Vitano® compared to individuals in the control condition

Vitano® will have positive effects on cognitive functioning.

Subjective ratings of stress will be reduced in individuals exposed to Vitano® compared to individuals in the control condition

There will be a significant improvement in subjective well-being in individuals taking Vitano®.

Study Overview

• Status: Completed
• Conditions: Mild Stress/Anxiety
• Intervention / Treatment: Drug: Vitano

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XP
      • University of Surrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• subject is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
• The subject has signed the ICF.
• Healthy male or female subjects aged 18-35 years inclusive. Attempts will be made to achieve an equal gender ratio through appropriate screening procedures, but a failure to do so will not preclude analysis of the final data set.
• A score above 30 on the Spielberger State-Trait Anxiety Inventory (STAI).
• The subject agrees to use suitable methods of contraception during the study and for 3 months afterwards.
• The subject is a non-smoker.
• The subject is, in the opinion of the Investigator, healthy on the basis of medical history, vital signs, and the results of routine laboratory tests.

Exclusion Criteria:

• The subject is pregnant or breast feeding.
• The subject consumes more than 5 caffeine-containing beverages per day.
• The subject is colour blind.
• Clinically significant hepatic or renal abnormality as determined by laboratory tests.
• BMI above 33.
• History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1.
• Positive alcohol breath test at any visit. A repeat test will not be allowed. [NOTE: subjects must be told to avoid consumption of alcoholic beverages for at least 24 hours prior to attending the Centre].
• Use of any other medication which may interfere with study outcome and/or interfere with IMP within the 2 weeks or 5 half lives preceding the first treatment phase, with the exception of contraceptive pill, non-steroidal analgesics, and paracetamol. [NOTE: Concomitant medications which do not influence study outcome and/or do not interfere with IMP may be allowed at the discretion of the Investigator].
• Current participation in another clinical trial with an investigational or non-investigational drug or device, or participation in another clinical trial within the 3 months preceding Visit 1 (screening visit).
• Any condition that, in the Investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
• Moderate or severe anxiety* *If participants are found to have moderate or severe anxiety during the screening process then they will be referred to the University Counselling service.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitano	Drug: Vitano; two 200mg tablets per day for 14 days
No Intervention: Control; No tablets - control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure measurements	Blood pressure readings taken under laboratory conditions during cognitive testing and relaxation periods	Measurements over 14 days (Day 0, Day 7 and Day 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of cognitive function	cognitive function assessed four times during the 14 day study period	14 days

Collaborators and Investigators

• Sponsor: University of Surrey
• Collaborators: Dr. Willmar Schwabe GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: CRC287