NCT06482554招募中3 期
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Louisiana State University Health Sciences Center Shreveport1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in AES-C Score
研究概览
简要总结
This study is looking to determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy (Apathy Evaluation Scale - Clinician - Apathy) assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.
详细描述
- To determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy assessment.
- To examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.
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
- Double (Participant, Investigator)
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 between the ages of 18-65 that have been diagnosed with Schizophrenia, Schizoaffective Disorder or Schizophrenia Spectrum and Other Psychotic Disorders.
- •A BPRS score > 35 at the screening visit.
- •An AES-C score > 32 at the screening visit.
- •If the subject is on a therapeutic regimen, that regimen must be stable for at least 30 days prior to screening. A therapeutic regimen may include medication, supplements, and/or probiotics.
- •In the opinion of the Investigator, the subject is able to participate in all scheduled evaluations, and likely to be compliant and complete all required assessments.
- •Female subjects of childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative urine pregnancy test. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 30 days after the last dose of study drug.
- •Must speak and understand English, as the consent and all evaluations will be conducted in English.
- •Must be willing to take and pass a urine drug screen with a negative result in order to rule out psychotic symptoms due to drugs of abuse.
排除标准
- •A BPRS score < 35 at the screening visit.
- •An AES-C score < 32 at the screening visit.
- •Have any clinically significant medical condition or an unstable intercurrent illness that would, in the opinion of the Investigator, preclude study participation.
- •Are currently taking more than one antipsychotic medication.
- •Are currently taking a long-acting injectable medication for psychotic symptoms.
- •Have a substance use disorder or show a positive drug screen for stimulants.
- •Are pregnant or of female sex with no evidence of measures for pregnancy prevention.
- •Presence of dementia.
- •Intellectual disability or cognitive impairment that would affect the symptom/apathy assessments, in the view of the investigator.
- •A diagnosis of Parkinson's disease.
研究组 & 干预措施
Lumateperone
Active Comparator
42mg capsule, once a day for 8 weeks
干预措施: Lumateperone 42 mg (Drug)
Existing medication
Active Comparator
Existing medication reformulated in capsule, once or twice daily (as currently prescribed) for 8 weeks
干预措施: Risperidone 2 mg (Drug)
结局指标
主要结局
Change in AES-C Score
时间窗: 8 weeks
Difference between the mean change in the AES-C score from baseline (V1) to Week 8 (V3) for 42 mg/day lumateperone vs. current antipsychotic medication.
次要结局
- Change in PANSS Score(8 weeks)
- Change in BPRS Score(8 weeks)
- Correlations between AES-C and PANSS Scores(8 weeks)
研究者
Shawn McNeil
Principal Investigator
Louisiana State University Health Sciences Center Shreveport
研究点 (1)
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