NCT04510298已完成1 期
A Pilot, 4-Week, Randomized, Double-Blind, Placebo-Controlled, Inpatient, Multicenter Study of the Safety, Population Pharmacokinetics, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.
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
- •Is willing and able to provide written informed consent to participate in the study.
- •Has an identified reliable informant.
- •Is, in the investigator's opinion, suitable for initiating a washout from the subject's current antipsychotic regimen, if applicable, and is willing to abstain from prohibited psychotropic medications in accordance with study requirements.
- •Subjects must meet screening eligibility criteria and be in an inpatient setting prior to discontinuing antipsychotic medications.
- •Subject must be able, in the investigator's opinion, to safely discontinue prohibited psychotropic medications prior to Baseline without increased suicidality.
- •Has a primary diagnosis of schizophrenia based on the Diagnostic and Statistical Manual 5th edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders Studies.
- •Is experiencing an acute exacerbation or relapse of symptoms.
- •Is in generally good physical health, in the investigator's opinion, based on Screening medical history, physical examination, vital signs, and clinical laboratory values.
- •Has a body mass index (BMI) between 18 and 40 kg/m2, inclusive.
- •For women of reproductive potential: has a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
- •For women of reproductive potential and men with female partners of reproductive potential: agrees to remain abstinent from sexual intercourse or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug.
排除标准
- •Is a woman who is pregnant, breastfeeding, or less than 6 months postpartum at Screening.
- •Has any primary DSM-5 disorder other than schizophrenia, as confirmed by the MINI.
- •Fails to discontinue prohibited psychotropic medications.
- •Has, in the investigator's opinion, a significant risk of violent or destructive behavior.
- •Is currently hospitalized involuntarily or incarcerated.
- •Has a history or presence of any clinically significant medical condition, disease, or surgical history that could, in the investigator's opinion, jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug.
- •Is, in the investigator's opinion, not a suitable candidate for the study.
研究组 & 干预措施
SP-624
Experimental
SP-624 oral capsule, 20 mg once daily
干预措施: SP-624 (Drug)
Placebo
Placebo Comparator
Placebo oral capsule, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 8 weeks
次要结局
- Change from Baseline in Pulse Rate (beats per minute)(Up to 4 weeks)
- Number of Participants with Abnormal Clinical Laboratory Values(Up to 4 weeks)
- Change from Baseline in Body Weight (kilograms)(Up to 4 weeks)
- Change from Baseline in Blood Pressure (mmHg)(Up to 4 weeks)
- Change from Baseline in Body Temperature (degrees celsius)(Up to 4 weeks)
- Change from Baseline in ECG Heart Rate (beats per minute)(Up to 4 weeks)
- Change from Baseline in ECG RR Interval (seconds)(Up to 4 weeks)
- Change from Baseline in ECG PR Interval (milliseconds)(Up to 4 weeks)
- Change from Baseline in ECG QTcF Interval (milliseconds)(Up to 4 weeks)
- Number of Participants with Abnormal Physical Examination Findings(Up to 4 weeks)
- Number of Participants with treatment-emergent suicidal ideation or behavior(Up to 5 weeks)
- Number of Participants with treatment-emergent abnormal movements(Up to 4 weeks)
研究者
研究点 (2)
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