Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750402.01.028
Study information
Scientific title
The effects of Sokatin® on mood and cognitive function: a double-blind, placebo-controlled, randomised cross-over study
Acronym
Study hypothesis
To investigate if daily oral intake of 500 mg Sokatin® improves mood and cognitive function in healthy subjects.
Ethics approval
The Research Subjects and Patients Medical Ethical Review (Medisch-Ethische Toetsing Onderzoek Patienten en Proefpersonen [METOPP]) approved on the 20th October 2010 (ref: M375; NL 33836.028.10)
Study design
Explorative randomised double blind placebo controlled crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mood/cognitive function
Intervention
Daily intake of one tablet Sokatin® for a period of eight weeks (test) or daily intake of one placebo tablet for a period of eight weeks (control) and vice versa with a wash-out period of 2 weeks in between.
Intervention type
Drug
Phase
Phase I/II
Drug names
Sokatin®
Primary outcome measures
1. Cognitive performance:
1.1. Emotional Stroop Test
1.2. Colour Word Vigilance Test
1.3. N-back Test
1.4. Vigilance and Tracking Test
1.5. Switching Attention Test
1.6. Long-term Memory Task
2. Profile of Mood States Questionnaire
The assessment of mood and cognitive performance using the selected cognitive tests of a computerised validated test system are performed on day 01, day 57, day 71 and day 127.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
25/10/2010
Overall trial end date
28/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy volunteers (male and female) aged 30 to 50 years
2. Able to perform easy actions on a computer
3. Candidates with scores greater than or equal to 45 in the State-Trait Anxiety Inventory (STAI-T) during screening
4. Having given written informed consent
5. Willing to comply with the study procedures
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
34
Participant exclusion criteria
1. Participation in any clinical trial up to 90 days before Day 01 of this study
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study
3. Having a history of medical or surgical events that may significantly affect the study outcome, including psychiatric disorders
4. Being colour-blind
5. Use of antidepressants
6. Being hypersensitive to any ingredient of the study substances
7. Use of supplements from screening towards the end of the study
8. Being a regular user of recreational drugs
9. Excessive alcohol consumption or excessive use of tobacco
10. Reported slimming or medically prescribed diet
11. Pregnant or lactating or wishing to become pregnant in the period of the study
12. Not having a general practitioner
Recruitment start date
25/10/2010
Recruitment end date
28/02/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Utrechtseweg 48
Zeist
3700
Netherlands
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary