临床试验/NCT00274677

NCT00274677已完成3 期

A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 221 人开始时间: 2003年11月最近更新: 2016年9月15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: 221
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

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

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

未提供

排除标准

未提供

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: lamotrigine (Drug)

lamotrigine

Experimental

干预措施: Placebo (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: Eight 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)(Eight 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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