NCT01125358终止2 期
A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Clinical Utility Index (CUI)
研究概览
简要总结
This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID)
- •Non pregnant female participants who agree to use acceptable birth control
- •At entry to the study must be considered moderately ill in the opinion of the investigator
- •1 year history of Schizophrenia prior to entering the study
- •At study entry participants with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study based on the investigator's clinical judgment. Participants who have never taken antipsychotic treatment may enter the study even without a history of hospitalization
- •At study entry participants with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Participants who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years
- •At study entry participants must have experienced an exacerbation of illness within the 4 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in participants who are presently hospitalized, the participants must not have been hospitalized longer than 60 days at entry of the study
排除标准
- •Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1
- •Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
- •Have any known history of receiving treatment with clozapine at any dose, as determined at baseline
- •Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study
- •Participants who are currently suicidal
- •Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
- •Participants with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, untreated thyroid condition or other serious or unstable illnesses
- •Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years
- •Participants are excluded if their biological father, mother, brother, sister, or child has a history of idiopathic epilepsy
- •Within 1 year of study enrollment, participants have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive
- •Participants are excluded if they have a lifetime history of any of the following:
- •head trauma, stroke, or central nervous system (CNS) infection with persistent neurological deficit (focal or diffuse);
- •brain surgery;
- •an electroencephalogram with paroxysmal (epileptiform) activity, or
- •brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome
- •Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study
- •Leukopenia
- •Medical history of Human Immunodeficiency Virus positive (HIV+) status
- •Higher than normal blood prolactin levels
- •Certain electrocardiogram results
研究组 & 干预措施
10 milligrams (mg) LY2140023
Experimental
干预措施: LY2140023 (Drug)
80 mg LY2140023
Experimental
干预措施: LY2140023 (Drug)
160 mg LY2140023
Experimental
干预措施: LY2140023 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Utility Index (CUI)
时间窗: Baseline through Week 6
CUI measures the efficacy (response), tolerability (time on treatment) and safety \[incidence of adverse events (AEs)\] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.
次要结局
- Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale(Baseline, Week 6)
- Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)(Baseline, Week 6)
- Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)(Baseline, Week 6)
- The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline up to Week 6)
- Percentage of Participants Who Discontinued (Rate of Discontinuation)(Baseline through Week 6)
研究者
研究点 (1)
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