EUCTR2020-000688-22-DE进行中（未招募）1 期
Multi-centre, double-blind, placebo- and reference-controlled, randomised trial to prove the efficacy and safety of Silexan (WS®1265) in patients with a major depressive episode of mild to moderate severity
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 498
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. Age of at least 18 years
- •2. Diagnosis of a major depressive episode according to ICD 10 (single episode: F32.0, 32.1, recurrent episode: F33.0, 33.1) of mild to moderate intensity (a maximum of 2 main- and =4 additional symptoms) with a duration of at least two weeks but not longer than one year.
- •3. MADRS total score for the inclusion in the run-in and into the acute treatment phase: 19 - 34
- •4. Out-patient treatment by a general or specialized physician.
- •5. Body weight: BMI between 18 and 35 kg/m2
- •6. Written informed consent in accordance with the legal requirement.
- •7. Readiness and ability on the part of the patient to comply with the physician’s instructions and to fill in the self-assessment scales.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 398
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Participation in a further clinical trial at the same time or in the last 12 weeks before screening
- •2. Diagnosis of MDD of severe intensity as defined by ICD-10 or rating of the MADRS total score > 34 at baseline visit.
- •3. Any clinically important psychiatric or neurological diagnoses according to ICD-10, other than study indication, within 6 months before the study such as:
- •schizophrenia,
- •acute anxiety disorder as primary diagnosis,
- •episodes of depression with any characteristics of a psychotic nature, depressive disorders not defined as inclusion criteria, bipolar disorder, cyclothymia, mania
- •organic, including symptomatic, mental disorders
- •post-traumatic stress disorder
- •eating disorders
- •4. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics.
- •5. Risk of suicide, or previous suicide attempt or clear display of auto-aggressive behaviour as defined (but not limited to) MADRS item 10
- •6. Lack of response to any adequate antidepressant therapy in the present episode of depression (adequate means = 150 mg amitriptyline-equivalents per day or SSRI treatment during at least 6 weeks) or lack of response to Sertraline (= 50 mg and during at least 6 weeks) in any previous episode. Patients who are already well adjusted to an antidepressant therapy in the present episode may not be enrolled into this study.
- •7. Any of the following treatments within 30 days before baseline visit:
- •Antidepressants
- •depot neuroleptics
- •MAO inhibitors
- •benzodiazepines
- •other psychotropic drugs
- •intravenous methylene blue
- •linezolid.
- •8. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment. The following medication is not allowed during the study:
- •any psychotropic drugs including
- •benzodiazepines, non-benzodiazepines, neuroleptics, tranquilizer, antidepressives, anxiolytics, antiepileptics, antihistaminics, MAO inhibitors, fluoxetine, pimozide, lamotrigine, linezolid, intravenous methylene blue
- •long-term prophylactic treatment
- •central-acting antihypertensive medication
- •xanthine derivatives such as Theophylline
- •antiparkinson medication
- •phytopharmaceuticals with anxiolytic properties
- •muscle relaxants
- •analgesics of opiate type
- •anaesthetics
- •barbiturates
- •nootropics
- •coumarin derivates
- •9. Non-medicinal psychiatric treatment during the last two weeks prior to baseline visit and during the course of the study
- •10. History of hypersensitivity to Lavender preparations or Sertraline and/or known allergies to the IMP, placebo or excipients
- •11. Any unstable acute medical disorder or clinically relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer, haematologic diseases or thyroid insufficiency including, epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson’s disease
- •12. Any somatic disease that necessitate regular treatment with systemic steroids.
- •13. Medical history of angle-closure glaucoma or untreated anatomical narrow angles in any eye.
- •14. Medical history of syndrome of inappropriate antidiuretic hormone secretion or hyponatremia in the laboratory analysis at visit 1.
- •15. Clinically significant abnormality of ECG and/or laboratory value(s).
- •16. Any abnormal baseline finding considered by the investigator to be indicative of conditions that
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