EUCTR2004-005069-39-CZ进行中（未招募）1 期
A double-blind, randomised, multicenter, comparative study of escitalopram and duloxetine in outpatients with Major Depressive Disorder
H.Lundbeck A/S0 个研究点目标入组 260 人开始时间: 2005年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- •Any patient who meets all of the following criteria is eligible for inclusion in this study:
- •1. The patient is able to read and understand the Patient Information Sheet.
- •2. The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form.
- •3. The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria
- •(classification code 296.xx) (current episode assessed with the MINI).
- •4. The patient is an outpatient, male or female.
- •5. The patient is aged = 18 and = 65 years.
- •6. The patient has a MADRS total score = 26 at the baseline visit.
- •7. The patient has a CGI-S score = 4 at the baseline visit.
- •8. The patient, in the opinion of the investigator, is otherwise healthy on the basis of a physical examination, medical history and vital signs.
- •Are the trial subjects under 18?
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.The patient has previously participated in this study.
- •2.The patient has a significant risk of suicide according to investigator’s opinion or presents a score =5 on item 10 (suicidal thoughts) of the MADRS.
- •3.The patient meets DSM-IV-TR criteria (as assessed with the MINI) for:
- •-current Obsessive-Compulsive Disorder,
- •-current Post-traumatic Stress Disorder,
- •-current Panic Disorder,
- •-past or current manic or hypomanic episode,
- •-past or current psychotic symptoms or disorder,
- •-current drug or alcohol abuse or dependence,
- •-current eating disorder (anorexia or bulimia).
- •4.The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- •5.The patient presents a personality disorder that might compromise the study.
- •6.The patient has increased intra-ocular pressure or is at risk of acute narrow-angle glaucoma.
- •7.The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance. (If there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient’s participation in the study, the patient may be included).
- •8.The patient uses disallowed recent or concomitant medication.
- •9.The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to citalopram, escitalopram, or duloxetine.
- •10.The patient has hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency.
- •11.The patient is pregnant or breast-feeding.
- •12.The patient, if a woman of childbearing potential, is not using adequate contraception.
- •13.The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
研究者
相似试验
进行中（未招募）
不适用
A double-blind, randomised, multicenter, comparativestudy of escitalopram and duloxetine in outpatients withMajor Depressive DisorderEUCTR2004-005069-39-DEH. Lundbeck A/S260
进行中（未招募）
1 期
A double-blind, randomised, multicenter, comparativestudy of escitalopram and duloxetine in outpatients withMajor Depressive DisorderMajor depressive disorderEUCTR2004-005069-39-SEH. Lundbeck A/S260
进行中（未招募）
1 期
A double-blind, randomised, multicenter, comparative study of escitalopram and duloxetine in outpatients with Major Depressive DisorderMajor depressive disorderEUCTR2004-005069-39-GBH. Lundbeck A/S260
进行中（未招募）
不适用
A double-blind, randomised, multicenter, comparative study of escitalopram and duloxetine in outpatients with Major Depressive DisorderMedDRA version: 6.1Level: PTClassification code 10057840Major Depressive DisorderEUCTR2004-005069-39-ITDBECK ITALIA260
进行中（未招募）
1 期
A multicentre, randomised, double-blind, comparative trial of a novel CCR5 antagonist, UK427,857, in combination with zidovudine/lamivudine versus efavirenz in combination with zidovudine/lamivudine for the treatment of antiretroviral-naïve HIV-1 infected subjectsK-427,857 is an antagonist of the human chemokine receptor, and is intended to help prevent the development and progression of AIDS in indivuduals HIV-1 positive.MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestationsEUCTR2004-001914-15-GBViiV Healthcare UK Limited891