Emotional memory and set shifting Mental and Behavioural Disorders Improving memory
Conditions
Interventions
1 tablet containing 500 mg Sokatin® or placebo taken in the morning.
Schedule:
Screening phase: up to 14 days
Treatment period 1: verum or placebo for 14 days once daily
Wash-out period: 14 days
Tre
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Memory tasks and set shifting measured with functional magnetic resonance imaging. Measured at day 15 (after treatment period 1) and day 43 (after treatment period 2) (no baseline measures for fMRI). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychometric testing with standardised questionnaires (Wisconsin Card Sorting test, emotional stroop test, Beck Depression Inventory [BDI], Social Adaptation Self-evaluation Scale [SASS], Cognitive Dissonance Test [DISS], Befindlichkeits Skala [Mood Scale, BF-S], Beschwerden Liste [Complaint List, B-L], Eigenschaftswörterliste [Adjective Checklist, EWL-60], 36-item short form health survey [SF-36], Quality of Life Enjoyment and Satisfaction Questionnaire [QLES-Q]) 2. Safety and tolerability Measured at day 1, day 15, day 29 and day 43. | — |
Countries
Germany
Outcome results
None listed