NCT06799559尚未招募3 期
A Multicenter, Randomized, Double-blind, Parallel Controlled Study on the Efficacy and Safety of QLM1016 in the Treatment of Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 402
- 主要终点
- change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
研究概览
简要总结
The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.
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
- •male or female subjects, ages 18-65 inclusive, with a clinical diagnosis of schizophrenia
- •PANSS total score ≥ 70 and ≤ 120，Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behavior, conceptual disorganization, and unusual thought content
- •CGI-S score ≥ 4
排除标准
- •Currently, meet DSM-5 diagnostic criteria for other psychiatric disorders ( for example schizoaffective disorder, schizophreniform disorder, bipolar I and II disorder; pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders；
- •known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study
研究组 & 干预措施
QLM1016
Experimental
干预措施: 3-6mg QLM1016 (Drug)
Aripiprazole oral solution film
Active Comparator
干预措施: 10-20 mg Aripiprazole oral solution film (Drug)
结局指标
主要结局
change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
时间窗: Time Frame: 6 weeks
次要结局
未报告次要终点
研究者
相似试验
Unknown
不适用
Validating and Optimizing Model of Antipsychotics SelectionSchizophreniaNCT03237052Shanghai Mental Health Center2,000
终止
2 期
Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).CoronavirusHypoxic Respiratory FailureHypoxemic Respiratory FailureRespiratory ComplicationRespiratory InsufficiencyCardiac DysfunctionPulmonary InflammationCytokine StormCOVID 19SARS-CoV-2PneumoniaCardiac EventCardiac ComplicationCardiac FailureCardiac InfarctRespiratory FailureAcute Respiratory Distress SyndromePulmonary EdemaNCT04433546PhaseBio Pharmaceuticals Inc.54
进行中（未招募）
不适用
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity SpasticitySpasticity, Cerebral or Spinal ConditionNCT06340451Pacira Pharmaceuticals, Inc132
已完成
3 期
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT01007435Hoffmann-La Roche1,162
已完成
3 期
An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) TherapyRheumatoid ArthritisNCT03155347Hoffmann-La Roche340