临床试验/NCT00056277

NCT00056277已完成3 期

Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 150 人开始时间: 2003年2月27日最近更新: 2017年4月7日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 150
试验地点: 1
主要终点: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients must provide written and informed consent
•Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
•Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior

排除标准

•Patients must not be suicidal
•Patients must not have a history or non-response to antidepressant treatment
•Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
•Patients must not have had epilepsy or hypothyroidism

研究组 & 干预措施

Arm 1

Other

干预措施: lamotrigine (Drug)

结局指标

主要结局

Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)

时间窗: 8 Weeks

次要结局

Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD - Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I).(8 Weeks)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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