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

This is an interventional treatment trial for Mild Stress/Anxiety Read More

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.