跳至主要内容
临床试验/NCT00086593
NCT00086593已完成3 期

A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects With Schizophrenia

GlaxoSmithKline40 个研究点 分布在 3 个国家目标入组 209 人开始时间: 2004年5月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
209
试验地点
40
主要终点
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.

研究概览

简要总结

This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.

时间窗: 12 Weeks

次要结局

  • - Efficacy - Change from baseline in PANSS positive symptoms at Week 12 - Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12 - Change from baseline in PANSS general psychopathology symptoms at Week 12.(12 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (40)

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