ISRCTN31235821已完成不适用
Multi-centre, open-label clinical trial to evaluate the efficacy and safety of Rhodiola rosea extract WS® 1375 in patients with burnout symptoms
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 120 人开始时间: 2011年6月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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