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 280 人2012年1月26日

适应症Schizophrenia MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Schizophrenia
发起方: Eli Lilly and Company
入组人数: 280
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

2012年1月26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 clinically diagnosed with schizophrenia
•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
•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 280
•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 LY2140023
•Have any other current psychiatric diagnoses in addition to schizophrenia
•Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity, except for patients who are rolling over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 LY2140023
•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 to antipsychotic treatment for schizophrenia
•Patients who, for any reason, are considered to be a danger to themselves, or who are actively exhibiting suicidal behaviors
•Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
•Have known, uncorrected, narrow\-angle glaucoma
•Patients with current or a history of seizure disorder, leucopenia, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
•Patients who have had electroconvulsive therapy (ECT) within 3 months of Visit 1 or who will have ECT at any time during the study