EUCTR2010-024632-42-GR进行中（未招募）不适用
Y2216684 compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder - LNB
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,045
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
- •Clinical diagnosis of Major Depressive Disorder (MDD).
- •Using a reliable method of birth control.
- •Are taking an SSRI approved for MDD treatment within the patient's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country.
- •Have a partial response to SSRI treatment.
- •Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment.
- •Reliable and able to keep all scheduled appointments.
- •Have had at least 1 previous episode of MDD prior to the current episode within the past 5 years.
- •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 1840
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 205
排除标准
- •Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening.
- •Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias).
- •Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder.
- •Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSMIV-TR), not including caffeine and nicotine.
- •Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol.
- •Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, history of urinary hesitation or retention.
- •Use of excluded concomitant or psychotropic medication other than SSRI.
- •Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment.
- •Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery.
- •Have received electroconvulsive therapy (ECT) in the past year
- •Enrollment in a clinical study for an investigational drug.
- •Serious or unstable medical condition.
- •History of seizure disorders.
- •Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 12 weeks prior to enrollment or any time during the study.No change in intensity of psychotherapy within the last 6 weeks prior to enrollment or at any time during the study.
- •Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others.
- •Are pregnant or breastfeeding.
研究者
相似试验
进行中（未招募）
不适用
A Study in Prevention of Re-emergence of Depression Symptomsmajor depressive disorderMedDRA version: 14.1Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2010-024632-42-ITELI LILLY2,045
撤回
2 期
An evaluative study on the safety and efficacy of standard anti-emetics compared to standard anti-emetics plus natural cannabinoids extract for the treatment of chemotherapy induced nausea and vomitingEmetogenicityChemotherapy induced nausea and vomitingCancer - Any cancerCancerACTRN12615000414516The University of Sydney224
已完成
不适用
This study is to establish how Pine bark extract (Trademark: Pinorox) is effective and tolerable in normal and sports subjectsCTRI/2019/03/018174Ambe Phytoextract Pvt Ltd50
进行中（未招募）
1 期
Study of mepolizumab vs. placebo in patients with HES who receive standard therapysevere hypereosinophilic syndromeMedDRA version: 20.0 Level: PT Classification code 10048643 Term: Hypereosinophilic syndrome System Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2014-001232-11-GBGlaxoSmithKline Research & Development Ltd120
进行中（未招募）
1 期
Study of mepolizumab vs. placebo in patients with HES who receive standard therapyEUCTR2014-001232-11-PLGlaxoSmithKline Research & Development Ltd120