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

This study has been completed.
Sponsor:
Collaborator:
Dr. Willmar Schwabe GmbH & Co. KG
Information provided by:
University of Surrey
ClinicalTrials.gov Identifier:
NCT01411709
First received: July 28, 2011
Last updated: August 5, 2011
Last verified: August 2010
  Purpose

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®.


Condition Intervention Phase
Mild Stress/Anxiety
Drug: Vitano
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress Assessed Under Laboratory Conditions And In Everyday Life

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Blood pressure measurements [ Time Frame: Measurements over 14 days (Day 0, Day 7 and Day 14) ] [ Designated as safety issue: No ]
    Blood pressure readings taken under laboratory conditions during cognitive testing and relaxation periods


Secondary Outcome Measures:
  • Measures of cognitive function [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    cognitive function assessed four times during the 14 day study period


Enrollment: 80
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitano Drug: Vitano
two 200mg tablets per day for 14 days
No Intervention: Control
No tablets - control group
Drug: Vitano
two 200mg tablets per day for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411709

Locations
United Kingdom
University of Surrey
Guildford, Surrey, United Kingdom, GU2 7XP
Sponsors and Collaborators
University of Surrey
Dr. Willmar Schwabe GmbH & Co. KG
  More Information

No publications provided

Responsible Party: Dr Hubert Bland, University of Surrey
ClinicalTrials.gov Identifier: NCT01411709     History of Changes
Other Study ID Numbers: CRC287
Study First Received: July 28, 2011
Last Updated: August 5, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Anxiety Disorders
Stress, Psychological
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014