A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group,Three Week Placebo Controlled Trial Evaluating the Safety andEfficacy of Asenapine in Subjects With Bipolar 1 DisorderExperiencing an Acute Manic or Mixed Episode (Protocol P05691[Formerly 041044])

Schering-Plough Research Institute, a Division of Schering0 个研究点目标入组 366 人开始时间: 2012年5月19日最近更新: 2014年11月3日

适应症

试验速览

暂无简介。

•- Each participant must be at least 18 years of age
•- Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating,
•and is using a medically accepted method of contraception
•- Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or
•- Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1
•- Each participant must have discontinued the use of all prohibited psychotropic medications
•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 331
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•- A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis
•1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and
•functional impairment)
•- A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical
•Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance
•abuse or dependence (excluding nicotine)
•- A participant must not be at imminent risk of self-harm or harm to others, in the investigator's
•opinion based on clinical interview and responses provided on the Columbia Suicide Severity
•Rating Scale (CSSRS).

发起方

Schering-Plough Research Institute, a Division of Schering