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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01411709
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : March 30, 2015
Dr. Willmar Schwabe GmbH & Co. KG
Information provided by:
University of Surrey

Brief Summary:

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 or disease Intervention/treatment Phase
Mild Stress/Anxiety Drug: Vitano Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Active Comparator: Vitano Drug: Vitano
two 200mg tablets per day for 14 days

No Intervention: Control
No tablets - control group

Primary Outcome Measures :
  1. Blood pressure measurements [ Time Frame: Measurements over 14 days (Day 0, Day 7 and Day 14) ]
    Blood pressure readings taken under laboratory conditions during cognitive testing and relaxation periods

Secondary Outcome Measures :
  1. Measures of cognitive function [ Time Frame: 14 days ]
    cognitive function assessed four times during the 14 day study period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01411709

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

Responsible Party: Dr Hubert Bland, University of Surrey Identifier: NCT01411709     History of Changes
Other Study ID Numbers: CRC287
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms