E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Burnout symptoms like exhaustion, fatigue, mild anxiety, mood disturbances |
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E.1.1.1 | Medical condition in easily understood language |
symptoms of life stress, caused by professional, social and and other external burdens. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 4 at Baseline
6. A level > 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | 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
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The clinical trial is concluded on reaching the target number of patients.
The entire trial can be terminated prematurely when:
- serious adverse drug reactions indicate that this is appropriate
- new data about the properties of the test drug are made known or medical / ethical reasons make this necessary.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 21 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 21 |
E.8.9.2 | In all countries concerned by the trial days | 0 |