A 17-Week, Phase 2, Multicenter, Randomized, Double-Blind Study of Treatment With LY2140023 Combined With Standard of Care (SOC) Compared to Placebo With SOC in the Treatment of Patients With Prominent Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16)
研究概览
简要总结
The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.
详细描述
The primary objective of this study was to test the hypothesis that treatment with LY2140023 compared to placebo, when added to a fixed dose of a standard of care (SOC) antipsychotic, would demonstrate significantly greater reduction of negative symptoms, as assessed by the 16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. Patients included in this study were concurrently receiving 1 of 4 second generation antipsychotics (SGAs): aripiprazole, olanzapine, risperidone, or quetiapine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of schizophrenia
- •Participants must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine)
- •Disease symptoms must meet a certain range as assessed by the clinician
- •Participants must have evidence of prominent negative symptoms of schizophrenia (for example blunted affect, emotional withdrawal, or motor retardation)
- •Participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
- •Participants must be able to understand the nature of the study and have given their informed consent
排除标准
- •Participants who are actively suicidal
- •Participants who are pregnant or nursing
- •Participants who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
- •Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
- •Participants with Parkinson's disease, psychosis related to dementia or related disorders
- •Participants with known Human Immunodeficiency Virus positive (HIV+) status
研究组 & 干预措施
LY2140023
40 mg/day, given orally twice daily (BID) as a 20-mg tablet. LY2140023 dosage was adjustable from 10 mg to 40 mg BID.
干预措施: Standard of Care (Drug)
LY2140023
40 mg/day, given orally twice daily (BID) as a 20-mg tablet. LY2140023 dosage was adjustable from 10 mg to 40 mg BID.
干预措施: LY2140023 (Drug)
Placebo
Placebo tablets to match LY2140023 tablets
干预措施: Placebo (Drug)
Placebo
Placebo tablets to match LY2140023 tablets
干预措施: Standard of Care (Drug)
结局指标
主要结局
Change From Baseline in the 16-Item Negative Symptoms Assessment (NSA-16)
时间窗: Baseline, randomization treatment Week 16
The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The total score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measure (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values are controlled for visit, pooled investigative site, treatment, standard of care (SOC) type, baseline positive symptom stratum, treatment\*visit, baseline NSA-16 total score, and baseline NSA-16 total score\*visit.
次要结局
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score(Baseline, randomization treatment Week 16)
- Change From Baseline in Standing Blood Pressure (BP)(Baseline, randomization treatment Week 16)
- Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - General(Baseline to randomization treatment Week 16)
- Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Cholesterol(Baseline to randomization treatment Week 16)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline, randomization treatment Week 16)
- Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale(Baseline, randomization treatment Week 16)
- Change From Baseline in Barnes-Akathisia Scale (BAS) Global Score(Baseline, randomization treatment Week 16)
- Change From Baseline in Simpson Angus Scale (SAS) Total Score(Baseline, randomization treatment Week 16)
- Change From Baseline in Weight(Baseline, randomization treatment Week 16)
- Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) Overall Composite T-Score(Baseline, randomization treatment Week 16)
- Change From Baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) Total Score(Baseline, randomization treatment Week 16)
- Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Glucose(Baseline to randomization treatment Week 16)
- Percentage of Participants With Incidence of Potentially Clinically Significant Change of Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline to randomization treatment Week 16)
- Change From Baseline to Endpoint in Personal and Social Performance (PSP) Scale(Baseline, randomization treatment Week 16)
- Time to Discontinuation From the Study Due to Any Reason(First dose to randomization treatment Week 16)
- Schizophrenia Resource Use Module (S-RUM) - Number of Emergency Room (ER) or Equivalent Facility Visits and Outpatient Medical Visits(Baseline to randomization treatment Week 16)
- Schizophrenia Resource Use Module (S-RUM) - Number of Sessions With a Psychiatrist(Baseline to randomization treatment Week 16)
- Number of Participants With Incidence of Epileptiform Activity Outside of Normal Range in Electroencephalograms (EEGs)(Baseline to randomization treatment Week 16)
- Number of Participants With Incidence of Potentially Clinically Significant Changes in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) Electrocardiograms (ECGs)(Baseline to randomization treatment Week 16)
- Percentage of Participants With a Worsening of Neurological Symptoms From Baseline to Endpoint on the Neurological Examination(Baseline to randomization treatment Week 16)
- Change From Baseline to Endpoint in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-SF) Total Score(Baseline, randomization treatment Week 16)
- Change From Baseline in Standing Pulse Rate(Baseline, randomization treatment Week 16)
- Number of Participants With Incidence of Potentially Clinically Significant (PCS) Change in Laboratory Values Any Time Post-Baseline - Fasting Triglycerides(Baseline to randomization treatment Week 16)
- Change From Baseline to Endpoint in the EuroQol Questionnaire-5 Dimension (EQ-5D) Visual Analog Scale (VAS) Health State Score(Baseline, randomization treatment Week 16)