Status:
COMPLETED
A Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress
Lead Sponsor:
University of Surrey
Collaborating Sponsors:
Dr. Willmar Schwabe GmbH & Co. KG
Conditions:
Mild Stress/Anxiety
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01411709
Start Date
January 1 2011
End Date
July 1 2011
Last Update
March 30 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Surrey
Guildford, Surrey, United Kingdom, GU2 7XP