ISRCTN36202964已完成3 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
Dr Willmar Schwabe (Germany)0 个研究点目标入组 577 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 577
研究概览
简要总结
2024 Results article in https://doi.org/10.1007/s00406-024-01783-2 (added 17/06/2024)
研究设计
- 研究类型
- Interventional
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
- •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. 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
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 (single episode: F32.2, recurrent episode: F33.2) 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
- •4. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics (F10- F19)
- •5. Risk of suicide, or previous suicide attempt or clear display of auto-aggressive behaviour as defined (but not limited to) MADRS item 10 suicidal thoughts” score =1 and or a (BSS)-5-Item Screen score =1
- •6. Lack of response to any adequate antidepressant therapy in the present episode of depression or lack of response to Sertraline 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, pimozide, 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, long-term prophylactic treatment (e.g. lithium, carbamazepine), central-acting antihypertensive medication (guanethidine, guanoxan, clonidin, prazosine, a-methyldopa, reserpine), digoxin, 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, 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 (SIADH) or hyponatremia in the laboratory analysis at visit 1
- •15. Clinically significant abnormality of ECG and/or laboratory value
- •16. Any abnormal baseline finding considered by the investigator to be indicative of conditions that might affect study results
- •17. Positive pregnancy test during visit 1
- •18. Pregnancy, planning of pregnancy or lactation
- •19. Patients capable of childbearing if not using adequate contraception, depending on the gender of the patient the respective contraception applies to their partners during the trial period
- •20. Gastrointestinal disorders with uncertain absorption of orally administered drugs
- •21. Unable to read, understand and/or complete questionnaires
- •22. History or suspicion of unreliability, poor cooperation or
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