Effects of Sokatin® on emotional memory and set shifting

Completed

• Conditions: Emotional memory and set shifting; Mental and Behavioural Disorders; Improving memory

• Registration Number: ISRCTN70153100
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

1. Aged 20 - 30 years
2. Male
3. Caucasian
4. Informed consent in accordance with the legal requirements
5. Healthy
6. Normal body weight

Exclusion Criteria

1. Subjects with conspicuous findings in medical history and pre-study examination
2. Blood donation of approximately 500 ml within 3 months prior to the study start
3. A history of relevant diseases of vital organs, of the central nervous system or other organs
4. Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
5. Febrile illness within 1 week before the start of the study
6. Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
7. Regular daily consumption of more than 10 cigarettes
8. Regular daily consumption of more than half a litre of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
9. Regular use of therapeutic or recreational drugs
10. Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
11. Relevant deviation from the normal range in the clinical examination
12. Relevant deviation from the normal range in clinical chemistry, haematology or urinalysis
13. Resting heart rate in the awake subject below 45 beats per minute (BPM) or above 90 BPM
14. Systolic blood pressure below 100 mmHg or above 140 mmHg
15. Diastolic blood pressure above 85 mmHg
16. Subjects testing positive in the drug screening
17. Excluded therapies (e.g., physiotherapy, acupuncture, etc)
18. Gastrointestinal disorders with uncertain absorption of orally administered drugs
19. Volunteer in custody or submitted to an institution due to a judicial order
20. Contraindications for magnetic resonance imaging: metallic implants (including non-removable body piercing), large tattoos, medical or biostimulation implants such as pacemaker, claustrophobia, allergy to the contrast agent

Study & Design

• Study Type: Interventional
• Study Design: Not specified