Evaluating the efficacy and safety of Rhodiola rosea extract WS® 1375 in patients with burnout symptoms

Completed

• Conditions: Burnout symptoms; Mental and Behavioural Disorders; Mood [affective] disorders

• Registration Number: ISRCTN31235821
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures