EUCTR2011-002292-41-GR进行中（未招募）不适用
A Phase 3, Short-Term, Multicenter, Placebo-Controlled, Randomized Withdrawal Study of LY2140023 Monohydrate in Patients with DSM-IV-TR Schizophrenia - HBDF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000)
- •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.
- •Patients must require a modification of antipsychotic medication or the initiation of antipsychotic medication, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product 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.
- •Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •Are Lilly employees
- •Patients for whom treatment with LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated
- •Are hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months of Visit 1
- •Have a CGI-S score >4 at Visit 1
- •Have any other current Axis I 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- •Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
- •Patients who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses >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. For this study, inadequate clinical response is defined as persistent and moderately severe hallucinations, delusions, or thought disorder after completion of 2 or more antipsychotic medication trials of at least 8 weeks duration the past 12 months prior to Visit 1.
- •Patients who require concomitant treatment with any other medication with primary central nervous system (CNS) activity, other than those allowed as specified in Section 9.8 (Concomitant Therapy) of the protocol or with any other medication specifically excluded in the Concomitant Medications attachment (Attachment 3) of the protocol
- •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
- •Patients who are actively suicidal
- •DSM-IV-TR diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to Visit 1
- •Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of Visit 1 (or at any time during the study)
- •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
- •Have a history of 1 or more seizures
- •Patients who have had electroconvulsive therapy (ECT) within 3 months of Visit 1 or who will have ECT at any time during the study
- •Patients with untreated hyper- or hypothyroidism.
- •Have leukopenia or a history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the patient’s lifetime
- •Patients with known medical history of human immunodeficiency virus positive (HIV+) status
- •Patients who test positive for (1) Hepatitis C virus antibody or (2)Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
- •Patients with ALT/SGPT or AST/SGOT values >2 times ULN of the performing laboratory, or total bilirubin values >1.5 times the ULN of the performing laboratory at Visit 1
研究者
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