The effects of Sokatin® on mood and cognitive function

ISRCTN ISRCTN59780402
DOI https://doi.org/10.1186/ISRCTN59780402
Secondary identifying numbers 750402.01.028
Submission date
22/10/2010
Registration date
03/12/2010
Last edited
03/12/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Esther Boelsma
Scientific

Utrechtseweg 48
Zeist
3700
Netherlands

Study information

Study designExplorative randomised double blind placebo controlled crossover study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effects of Sokatin® on mood and cognitive function: a double-blind, placebo-controlled, randomised cross-over study
Study objectivesTo investigate if daily oral intake of 500 mg Sokatin® improves mood and cognitive function in healthy subjects.
Ethics approval(s)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)
Health condition(s) or problem(s) studiedMood/cognitive function
InterventionDaily 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I/II
Drug / device / biological / vaccine name(s)Sokatin®
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date25/10/2010
Completion date28/02/2011

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants34
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment25/10/2010
Date of final enrolment28/02/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Utrechtseweg 48
Zeist
3700
Netherlands

Sponsor information

Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry

Willmar-Schwabe-Strasse 4
Karlsruhe
76227
Germany

ROR logo "ROR" https://ror.org/043rrkc78

Funders

Funder type

Industry

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan