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
Scientific
Utrechtseweg 48
Zeist
3700
Netherlands
Study information
| Study design | Explorative randomised double blind placebo controlled crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effects of Sokatin® on mood and cognitive function: a double-blind, placebo-controlled, randomised cross-over study |
| Study objectives | To 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Sokatin® |
| Primary outcome measure | 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 study start date | 25/10/2010 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 34 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 25/10/2010 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Utrechtseweg 48
Zeist
3700
Netherlands
3700
Netherlands
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Willmar-Schwabe-Strasse 4
Karlsruhe
76227
Germany
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
