EUCTR2011-003006-25-IT进行中（未招募）不适用
Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant.
SHIRE PHARMACEUTICALS LTD0 个研究点目标入组 1,034 人开始时间: 2013年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,034
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
- •- Subject has a primary diagnosis of non-psychotic MDD (single or recurrent) as defined by Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition – Text Revision? (SCID-CT) that has lasted ?8 weeks prior to the Screening Visit (Visit 1). - Subject has a MADRS total score ?24 at the Lead-in Baseline Visit (Visit 2)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1012
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •- Subject whose current episode of MDD has not responded to an adequate treatment regimen (at least 6 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more approved single antidepressant agents. Any subject whose current episode of MDD has not responded to an approved adjunctive treatment strategy is to be excluded. - Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment (at least 8 weeks of treatment at the maximum tolerated adult dose approved for the indication) with 2 or more treatment regimens, including, distinct classes of approved single antidepressant agents and adjunctive treatment strategies. - Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. - Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Excluded are: any significant Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa. - a history of serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a simulant medication, a history of moderate to severe hypertension or an average (of 3 readings) resting sitting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at the Screening Visit (Visit 1) and/or the Lead-in Baseline Visit (Visit 2), or current chronic or acute illness or unstable medical conditions that may deteriorate that could confound the results of safety assessments, increase risk to subjetc, or lead to difficulty complying with the protocol.
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