A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects with Acute Exacerbation of Schizophrenia

Alkermes Inc0 个研究点目标入组 390 人开始时间: 2016年2月25日最近更新: 2017年5月29日

适应症

试验速览

暂无简介。

•Each subject must meet all of the following inclusion criteria to be qualified to participate in this study.
•Is age 18–70 years, inclusive, at screening
•Has a body mass index (BMI) of 18.0–40.0 kg/m2, inclusive at screening
•Meets criteria for the diagnosis of schizophrenia.
•Resides in a stable living situation when not hospitalized
•Is willing and able to provide government-issued identification
•Additional criteria may apply
•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 370
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
•Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
•Subject poses a current suicide risk
•Subject has a history of treatment resistance
•Subject has a history of poor or inadequate response to treatment with olanzapine
•Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
•Subject has a diagnosis of moderate or severe alcohol or drug use disorder
•Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
•Additional criteria may apply

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