Effects of Sokatin® on emotional memory and set shifting

ISRCTN ISRCTN70153100
DOI https://doi.org/10.1186/ISRCTN70153100
Secondary identifying numbers 750402.01.020
Submission date
25/02/2010
Registration date
14/04/2010
Last edited
01/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francesca Regen
Scientific

Eschenallee 3
Berlin
14050
Germany

Study information

Study designSingle centre double-blind randomised placebo-controlled cross-over trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study objectivesThe 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(s)Ethik Kommission des Landes Berlin approved on the 8th December 2009 (ref: ZS EK 15 533/09)
Health condition(s) or problem(s) studiedEmotional memory and set shifting
Intervention1 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)Sokatin® (WS® 1261)
Primary outcome measureMemory 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 measures1. 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 study start date01/03/2010
Completion date31/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants2 x 24 (48 in total)
Key inclusion criteria1. Aged 20 - 30 years
2. Male
3. Caucasian
4. Informed consent in accordance with the legal requirements
5. Healthy
6. Normal body weight
Key exclusion criteria1. 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
Date of first enrolment01/03/2010
Date of final enrolment31/10/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

Eschenallee 3
Berlin
14050
Germany

Sponsor information

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

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

http://www.schwabe.de/schwabe/
ROR logo https://ror.org/043rrkc78

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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