EUCTR2006-001756-13-DE进行中（未招募）不适用
Multi-center, double-blind, placebo-controlled, four-arm, randomized phase II dose finding study with Sokatin® (WS® 1261) in patients with a Major Depressive Episode
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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 between 18 years and 65 years
- •2.Informed consent in accordance with the legal requirements. Patient is able to provide informed consent for the study (legally competent, physically and mentally capable of giving consent)
- •3.Diagnosis of a major depressive episode of moderate severity according to DSM-IV (single episode: 296.22, recurrent episode: 296.32; duration at least two weeks but not longer than one year). Anxiety may be present if not requiring specific treatment.
- •4.Severity of depression on the baseline visit: MADRS total score greater or equal 22
- •5.Patient is able to comply with the physician’s instructions and to fill in the self rating 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
- •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 a further clinical trial at the same time or within the past 4 weeks
- •2.Any of the following psychiatric diagnosis according to DSM-IV: schizophrenia (295.x, 297.x, 298.x), acute anxiety disorder (300.x, 302.x) as primary diagnosis, episodes of depression with any characteristics of a psychotic nature (296.24, 296.34) depressive disorders not defined as inclusion criteria (e.g. 300.4, 311), bipolar disorder (296.0, 296.4, 296.5, 296.6, 296.7, 296.8, 301.13), organic mental disorder (ICD-10: F06), acute post traumatic stress disorder (309.81), current abuse or dependence of any substance (except nicotine) or within the last two years
- •3.Risk of suicide, or previous suicide attempt or clear display of auto-aggresive behaviour as defined (but not limited to) MADRS item 10, score greater or equal 4
- •4.Lack of response to any adequate antidepressant therapy in the present episode of depression (adequate means: greater or equal 150 mg amitriptyline-equivalents per day or greater or equal 450 mg hypericum extract per day or SSRI treatment during at least 6 weeks)
- •5.Duration of the index episode > 1 year
- •6.Any of the following treatments within the indicated intervals before baseline visit: depot neuroleptics (2 months), MAO inhibitors (6 weeks, exception: moclobemide or other RIMAs), fluoxetine (6 weeks), benzodiazepines (2 weeks), other psychotropic drugs (1 week)
- •7.Non-medical psychiatric treatment during the last two weeks (e.g. standardised psychotherapy, sleep withdrawal, phototherapy, ECT)
- •8.Prohibited concomitant medication: any psychotropic drug (incl. benzodiazepines, antidepressants, OTC-drugs), antihypertensive medication with guanethidine, guanoxan, clonidin, prazosine, alpha-methyldopa, sedative drugs including antihistaminics (exception: less or equal 10 mg Stilnox® (zolpidem)/day), longterm prophylactic treatment (e.g. lithium, carbamazepine), reserpine
- •9.History of hypersensitivity to preparations from any part of cacteae
- •10.Any clinically relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer, haematologic diseases or thyroid insufficiency (exception: metabolic diseases like diabetes mellitus or anterior pituitary insufficiency on stable treatment), epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson’s disease
- •11.Pregnancy or lactation
- •12.Patients capable of childbearing if not using adequate contraception (intra-uterine devices, oral or injectable contraception)
- •13.Body Mass index > 35
- •14.Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
- •15. Patient is committted to an institution by order of authorities or a court's decision
研究者
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