Condition category
Mental and Behavioural Disorders
Date applied
16/02/2012
Date assigned
05/03/2012
Last edited
05/03/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Münte

ORCID ID

Contact details

Universitätsklinikum Schleswig-Holstein
Campus Lübeck
Klinik für Neurologie
Ratzeburger Allee 160
Lübeck
23538
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

578001.01.019

Study information

Scientific title

Single center, open-label clinical trial to study the effects of Rhodiola rosea extract WS 1375 on neuropsychological and neurophysiological measures of attention and mental resource allocation in healthy volunteers

Acronym

Study hypothesis

To gain initial insight in the possible influence of Rhodiola rosea extract WS 1375 on visual attention and mental resource allocation in healthy subjects at risk for stress symptomatology

Ethics approval

Medical Association of Schleswig-Holstein [Ethik Kommission des Universitätsklinikums Schleswig-Holstein], 14 February 2012, ref: 11-244

Study design

Single center open label exploratory trial

Primary study design

Interventional

Secondary study design

Non 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

Neuropsychological and neurophysiological measures

Intervention

One treatment arm only - Rhodiola rosea Extract WS 1375 (2 x 200mg) administered orally for 12 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Attention Network Task
2. Go/NoGo-Test
3. Divided Attention Test
4. Number Connection Test
5. Beck Depression Inventory II
6. Recent Perceived Stress Questionnaire
7. Event-related potentials

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/03/2012

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy male or female volunteers aged 30 to 50 years (both inclusive)
2. Signed Informed consent in accordance with the legal requirements
3. Sufficient language skills, readiness, and ability on the part of the subject to comply with the physicians instructions, respond to all interview questions, and to fill in the self-assessment scales without evident difficulties and without the assistance of an interpreter
4. Participants are required to work with a computer at least 15 hrs per week
5. Self-report of occasional visual and mental fatigue during computer work (scores 5 on at least 3 questions of the Ermdung und Computerarbeit questionnaire)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 subjects eligible for treatment

Participant exclusion criteria

1. Participation in another experimental drug trial at the same time or within the past 12 weeks before enrollment
2. Current hospitalization of the subject
3. Any clinically significant disease
4. Risk of suicide
5. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within the last 5 years
6. History of Axis I disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) at least one year before enrollment
7. History of head trauma that might be causally related to cognitive impairment
8. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) at least 4 weeks before the study
9. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment
10. Any clinically relevant hepatic, renal (serum creatinine or serum ASAT, ALAT or Gamma GT above 3 times the upper limit of the reference range), cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer (exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy), haematologic diseases or thyroid insufficiency, epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson's disease, diabetes mellitus
11. Any acute or chronic form of infection including Human immunodeficiency virus (HIV) infection or Lues of any stage (according to medical history or clinical signs and symptoms)
12. Known hypersensitivity to Rhodiola rosea extract
13. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
14. Pregnancy, lactation
15. Women capable of childbearing if not using adequate contraception (intra-uterine devices, injectable contraception, oral contraceptives plus one other contraceptive measure)
16.Score of 14 or higher on Beck Depression Inventory II (BDI II)

Recruitment start date

15/03/2012

Recruitment end date

31/07/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Schleswig-Holstein
Lübeck
23538
Germany

Sponsor information

Organisation

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

Sponsor details

Willmar Schwabe Str. 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

http://www.schwabepharma.com/

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