Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Siegfried Kasper


Contact details

Universitätsklinik für Psychiatrie und Psychotherapie
Medizinische Universität Wien
Währinger Gürtel 18-20

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Multi-centre, open-label clinical trial to evaluate the efficacy and safety of Rhodiola rosea extract WS® 1375 in patients with burnout symptoms


Study hypothesis

Evaluation of the clinical efficacy of Rhodiola rosea extract WS® 1375 to treat burnout symptoms and improve quality of life, mood, concentration and general health

Ethics approval

Ethics Committee of the Medical University of Vienna (Ethikkommission der Medizinischen Universität Wien und des AKH) approved on 31st May 2011 ref: EK-No 348/2011

Study design

Multi-centre open-label single arm trial

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Burnout symptoms


Treatment with Rhodiola rosea extract WS® 1375, 2 x 200 mg/day

Intervention type



Not Applicable

Drug names

Rhodiola rosea extract WS® 1375

Primary outcome measures

1. Maslach Burnout Inventory (MBI)
2. Burnout-Screening-Scales BOSS I and BOSS II
3. Seven Numerical Analogue Scales of subjective stress symptoms (NAS)
4. Subjects perceived stress level: 30 – items Recent Perceived Stress Questionnaire (PSQ)
5. Numbers Connecting Test
6. Sheehan Disability Scale (SDS)
7. Multidimensional Mood State Questionnaire (MDMQ)
8. NAS for Impairment of Sexual Life and Patient´s Sexual Function Questionnaire (PSFQ)
9. Clinical Global Impressions (CGI)

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Male or female outpatient employed subjects (police officers and other officers, nurses, physicians, IT specialists etc.) and subjects with other comparable burdens (e.g home caring of handicaped or demented family members) aged 30 to 60 years (both inclusive)
2. Signed Informed consent in accordance with the legal requirements
3. Moderate level of burnout for the following dimensions of the Maslach-Burnout Inventory (MBI):
3.1. Emotional exhaustion: level 1.81 – 2.80
3.2. Reduced personal performance: level 3.90 – 4.79
4. At least three of perceived Life Stress Symptoms listed below assessed between 5 and 8 on Negative Affectivity Scale (NAS):
4.1. Somatic symptoms: gastrointestinal or cardio-vascular disturbances, muscle tension or backache, frequent headaches
4.2. Loss of zest for life
4.3. Exhaustion
4.4. Irritability (exploding easily at seemingly inconsequential things)
4.5. Impairment of concentration
4.6. Feeling of heteronomy
4.7. Anxiety
5. Clinical Global Impression (CGI) Item 1: Score <4 at baseline
6. A level of >5 on the NAS for impairment of sexual life
7. Sufficient language skills, readiness, and ability on the part of the patient to comply with the physician’s instructions, respond to all interview questions, and to fill in the self-assessment scales without evident difficulties and without the assistance of an interpreter

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Participation in another experimental drug trial at the same time or within the past 12 weeks before enrolment
2. Current hospitalisation of the patient
3. Risk of suicide, item 3 of Hamilton Depression Rating Scale (HAM-D) assessed > 2
4. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within the last 5 years
5. History of Axis I disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) at least one year before enrolment
6. Generalized anxiety disorder (GAD) is excluded by module O of the M.I.N.I. and a major depression is excluded by module A of the M.I.N.I. and by a total score ≤ 16 in the Hamilton Scale of Depression (HAM-D) at screening
6. Non-medical psychiatric treatment (e.g. specific standardized psychotherapy) at least 4 weeks before the study
7. Intake of any prescribed psychotropic medication (see exclusion criterion no. 8) within one year before enrolment.
8. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment
9. Clinical significant abnormality of electrocardiogram (ECG) and/or laboratory value(s)
10. Any clinically relevant hepatic, renal [serum creatinine or serum aspartate transaminase (ASAT), alanine transaminase (ALAT) or gamma-GT above three 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, parkinsons disease
11. Any form of diabetes mellitus
12. Clinically significant anaemia
13. Clinically significant thyroid dysfunction as expressed by significant abnormality in thyroid-stimulating hormone (TSH), T3 and/or T4 levels
14. 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)
15. Known hypersensitivity to Rhodiola rosea extract or any ingredient of the drug under study

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Universitätsklinik für Psychiatrie und Psychotherapie

Sponsor information


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

Sponsor details

c/o Mrs Susanne Kraft
Willmar-Schwabe-Str. 4

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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