Condition category
Mental and Behavioural Disorders
Date applied
25/02/2010
Date assigned
14/04/2010
Last edited
01/09/2011
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 Francesca Regen

ORCID ID

Contact details

Eschenallee 3
Berlin
14050
Germany

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

http://www.schwabe.de/schwabe/

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