Burnout symptoms like exhaustion, fatigue, mild anxiety, mood disturbances
Conditions
Interventions
Trade Name: Vitango 200 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Sponsors
Dr. W. Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female outpatient employed subjects 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): a) Emotional exhaustion: level 1,81 – 2,80 b) reduced personal performance: level 3,90 – 4,79 4. At least 3 of perceived Life Stress Symptoms listed below assessed between 5 and 8 on NAS: a) Somatic symptoms b) Loss of zest for life c) Exhaustion d) Irritability e) Impairment of concentration f) Feeling of heteronomy g) Anxiety 5. CGI Item 1: Score or = 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 HAM-D > 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 DSM IV at least one year before enrolment. 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 (specified in section 6). 9. Clinical significant abnormality of ECG and/or laboratory value(s). 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. 11. Any form of diabetes mellitus. 12. Clinically significant anaemia. 13. Clinically significant thyroid dysfunction as expressed by significant abnormality in TSH, T3 and/or T4 levels. 14. Any acute or chronic form of infection including 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to describe the therapeutic effects, safety and tolerability of Rhodiola rosea extract WS® 1375 in subjects with Burnout symptoms;Secondary Objective: None;Primary end point(s): Treatment effect outcome variables: Maslach Burnout Inventory (MBI) Burnout Screening Scales BOSS I + II 7 NASs of Subjective Stress Symptoms Perceived Stress Questionnaire (PSQ) Numbers Connecting Test Sheehan Disability Scale (SDS) Multidimensional Mood State Questionnaire (MDMQ) NAS for Impairment of Sexual Life together with Patient´s Sexual Function Questionnaire (PSFQ) Clinical Global Impressions (CGI) Safety outcome variables: Physical Examination Vital Signs Adverse Events Laboratory Tests;Timepoint(s) of evaluation of this end point: Treatment effect outcome variables: Screening (Day -2) Day 7 Week 8 Week 12 Safety outcome variables: Physical Examination: Day -2, Week 12 Vital Signs: Days -2, 0, 7, week 8, week 12 Adverse Events: Day 7 and weeks 4, 8 and 12 Laboratory Tests: Day -2 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Austria
Contacts
Public ContactClinical Research
Dr. W. Schwabe GmbH & Co. KG
Outcome results
None listed