Evaluating the efficacy and safety of Rhodiola rosea extract WS® 1375 in patients with burnout symptoms
| ISRCTN | ISRCTN31235821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31235821 |
| Secondary identifying numbers | 578001.01.012 |
- Submission date
- 12/04/2011
- Registration date
- 22/06/2011
- Last edited
- 22/06/2011
- 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
Prof Siegfried Kasper
Scientific
Scientific
Universitätsklinik für Psychiatrie und Psychotherapie
Medizinische Universität Wien, AKH
Währinger Gürtel 18-20
Wien
1090
Austria
Study information
| Study design | Multi-centre open-label single arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | Burnout symptoms |
| Intervention | Treatment with Rhodiola rosea extract WS® 1375, 2 x 200 mg/day |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rhodiola rosea extract WS® 1375 |
| Primary outcome measure | 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 study start date | 31/07/2011 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 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 |
| Key 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 |
| Date of first enrolment | 31/07/2011 |
| Date of final enrolment | 30/04/2013 |
Locations
Countries of recruitment
- Austria
Study participating centre
Universitätsklinik für Psychiatrie und Psychotherapie
Wien
1090
Austria
1090
Austria
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
c/o Mrs Susanne Kraft
Willmar-Schwabe-Str. 4
Karlsruhe
76227
Germany
| Website | http://www.schwabepharma.com |
|---|---|
"ROR" |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
