Mild Stress/AnxietyPhase 4NCT01411709
A Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress
A Phase 4 study testing Vitano in people with Mild Stress/Anxiety, run by University of Surrey at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Stress/Anxiety
- What is being tested?
- Vitano
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read more
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®.
- Conditions
- Mild Stress/Anxiety
- Being tested
- Vitano
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitanoDrug
two 200mg tablets per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Vitano | Active comparator | Not described Receives: Drug: Vitano |
| Control | No intervention | No tablets - control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurements
Blood pressure readings taken under laboratory conditions during cognitive testing and relaxation periods
Measured: Measurements over 14 days (Day 0, Day 7 and Day 14)
Secondary outcomes (1)
Measures of cognitive function
cognitive function assessed four times during the 14 day study period
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Stress/AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Willmar Schwabe GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411709
- Sponsor's protocol ID
- CRC287
- Status last verified
- Mar 2015
- First submitted
- 28 Jul 2011
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01411709
- Acronym / sponsor ID
- CRC287
- Conditions
- Mild Stress/Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Dr. Willmar Schwabe GmbH & Co. KG
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitano | Active comparator | Drug: Vitano |
| Control | No intervention | –No tablets - control group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitanotwo 200mg tablets per day for 14 days | Drug | Vitano |
Primary outcome
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
1 secondary outcome
Measures of cognitive function
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitano in people with Mild Stress/Anxiety, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurements (time frame: Measurements over 14 days (Day 0, Day 7 and Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.