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The effects of Sokatin® on mood and cognitive function

The effects of Sokatin® on mood and cognitive function: a double-blind, placebo-controlled, randomised cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59780402
Enrollment
34
Registered
2010-12-03
Start date
2010-10-25
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood/cognitive function Mental and Behavioural Disorders Cognitive function

Interventions

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 b

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026