Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750402.01.020
Study information
Scientific title
A phase I study to assess the effects of repeated oral doses of Sokatin® (WS® 1261) for 2 weeks on emotional memory and set shifting in healthy volunteers
Acronym
Study hypothesis
The objective of this clinical trial is to describe the influence of a two weeks treatment with Sokatin® (WS® 1261) on emotional memory and set shifting as well as working memory measured with functional magnetic resonance imaging and with a battery of psychometric test scales in healthy volunteers.
Ethics approval
Ethik Kommission des Landes Berlin approved on the 8th December 2009 (ref: ZS EK 15 533/09)
Study design
Single centre double-blind randomised placebo-controlled cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Emotional memory and set shifting
Intervention
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
Treatment period 2: placebo or verum for 14 days once daily
Total duration after baseline: day 1 to day 43
Intervention type
Drug
Phase
Phase I
Drug names
Sokatin® (WS® 1261)
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/03/2010
Overall trial end date
31/10/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
2 x 24 (48 in total)
Participant 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
Recruitment start date
01/03/2010
Recruitment end date
31/10/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Eschenallee 3
Berlin
14050
Germany
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