EUCTR2010-022686-10-AT进行中（未招募）不适用
Multi-centre, open-label clinical trial to evaluate the efficacy and safety of Rhodiola rosea extract WS® 1375in Subjects with Burnout Symptoms - Burnout Austria
Dr. W. Schwabe GmbH & Co. KG0 个研究点开始时间: 2011年4月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
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 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.
研究者
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