Condition category
Mental and Behavioural Disorders
Date applied
22/10/2010
Date assigned
03/12/2010
Last edited
03/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Esther Boelsma

ORCID ID

Contact details

Utrechtseweg 48
Zeist
3700
Netherlands

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

Sponsor information

Organisation

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

Sponsor details

Willmar-Schwabe-Strasse 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes