ong-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients with Schizophrenia - A Long-Term, Open-Label Safety Study in Schizophrenia

Eli Lilly and Company0 个研究点目标入组 282 人2011年12月27日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Eli Lilly and Company
入组人数: 282
状态: 进行中（未招募）
最后更新: 13年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2011年12月27日

结束日期

待定

最后更新

13年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Eli Lilly and Company

入排标准

入选标准

•Patients are male or female, 18 to 65 years of age (inclusive) at study entry with a diagnosis of schizophrenia as defined in the DSM\-IV\-TR (APA 2000\) (Disorganized, 295\.10; Catatonic, 295\.20; Paranoid 295\.30; Residual 295\.60; or Undifferentiated, 295\.90\) and confirmed by the SCID. Patients who roll over from a feeder study are 18 to 65 years of age (inclusive) at time of entry into the feeder study, and no confirmatory diagnostic scale is needed.
•Female patients of childbearing potential must test negative for pregnancy at Visit 1 and agree to use a single, effective, medically acceptable method of birth control.
•In the opinion of the investigator, at Visit 1, new patients must require initiation of or modification to current antipsychotic treatment, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients.Criterion does not apply to patients rolling over from a feeder study.
•Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures.
•Patients must be able to understand the nature of the study and have given their own informed consent.
•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 282
•F.1\.3 Elderly (\>\=65 years) no

排除标准

•Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an IP or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, except for patients who are rolling over from a feeder study who will have completed a clinical trial of Pomaglumetad Methionil.
•Are investigator site personnel directly affiliated with this study and/or their immediate families.
•Are Lilly employees.
•Are hospitalized within 2 weeks of Visit 1 or have been hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months. For patients rolling over from a feeder study who are hospitalized within 2 weeks of rollover, contact sponsor to determine eligibility.
•Have any other current Axis I psychiatric diagnoses (as defined in DSM\-IV\-TR) in addition to schizophrenia.
•Have previously completed or withdrawn from this study, or any other study investigating Pomaglumetad Methionil or any predecessor molecules with glutamatergic activity, except for patients who are rolling over from a feeder study who will have completed a clinical trial of Pomaglumetad Methionil.
•Patients who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1\.
•Patients who have a history of an inadequate clinical response, in the opinion of the investigator, to antipsychotic treatment for schizophrenia.
•Patients who require concomitant treatment with any other medication with primary central nervous system (CNS) activity, other than those allowed.
•Patients who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1\.