Neuropsychological and neurophysiological measures Mental and Behavioural Disorders
Conditions
Interventions
One treatment arm only - Rhodiola rosea Extract WS 1375 (2 x 200mg) administered orally for 12 weeks.
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Germany
Outcome results
None listed