Clinical trial, performed in several trial sites, to evaluate the therapeutic effects and the safety of the herbal drug Rhodiola rosea extract WS® 1375 in patients with Burnout symptoms

• Conditions: Burnout symptoms like exhaustion, fatigue, mild anxiety, mood disturbances; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-022686-10-AT
• Lead Sponsor: Dr. W. Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-18
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified