The effects of Sokatin® on mood and cognitive functio

Completed

Conditions: Mood/cognitive function
Mental and Behavioural Disorders
Cognitive function

Registration Number: ISRCTN59780402

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 34

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cognitive performance: <br>1.1. Emotional Stroop Test<br>1.2. Colour Word Vigilance Test<br>1.3. N-back Test<br>1.4. Vigilance and Tracking Test<br>1.5. Switching Attention Test<br>1.6. Long-term Memory Task<br>2. Profile of Mood States Questionnaire<br><br>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