A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adult Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 21
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of 3 different doses of CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on stable dopaminergic antipsychotic medication.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of schizophrenia for the past 2 years
- •Patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (PANSS) total score of 70-110
- •Patients currently treated with one antipsychotic medication
排除标准
- •Patients who, in the opinion of the Investigator, have a history of antipsychotic treatment resistance
- •Patients currently taking clozapine
- •History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first Screening Visit
- •Patients with positive blood screen for human immunodeficiency virus (HIV) antibody and/or hepatitis B virus surface antigen
- •Patients with history of renal disease or those taking medications to treat renal disease
研究组 & 干预措施
Placebo
Participants received CTP-692 matched-placebo powder for oral solution, once daily (QD) for up to 12 weeks.
干预措施: Placebo (Drug)
CTP-692 1 gram QD
Participants received CTP-692 1 gram powder for oral solution, QD for up to 12 weeks.
干预措施: CTP-692 (Drug)
CTP-692 2 grams QD
Participants received CTP-692 2 grams powder for oral solution, QD for up to 12 weeks.
干预措施: CTP-692 (Drug)
CTP-692 4 grams QD
Participants received CTP-692 4 grams powder for oral solution, QD for up to 12 weeks.
干预措施: CTP-692 (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
时间窗: Baseline, Week 12
PANSS measures symptom severity in participants with schizophrenia. PANSS includes 30 items (7 items for positive symptoms, 7 items for negative symptoms, and 16 items for general psychopathology symptoms), and each item is rated with 1 to 7 points. The PANSS is scored by summation of ratings across items such that the score ranges are 7 to 49 for each of the Positive and Negative Scales and 16 to 112 for the General Psychopathology Scale. The PANSS total score is a sum of scores from all the 30 items and the scores range from 30 to 210, where a higher score represents more severe symptoms, and lower scores represent a better quality of life in participants with schizophrenia. A negative change from baseline indicates low severity of symptoms.
次要结局
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12(Baseline, Week 12)
- Change From Baseline in Personal and Social Performance (PSP) Scale at Week 12(Baseline, Week 12)