Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol.
Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).
详细描述
This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.
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
- •Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)
- •On clozapine treatment for at least 6 months
- •Stable dose of antipsychotic treatment for at least 1 month
- •Well established compliance with outpatient medications
- •Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.
排除标准
- •Psychiatrically unstable per clinical judgement by the principal investigator
- •Patients not on stable dose of antipsychotic medications
- •Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine
- •Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
- •History of a seizure disorder
- •Pregnancy or breastfeeding
- •On lumateperone treatment in the past 3 months
- •On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)
研究组 & 干预措施
Placebo
2 Placebo capsules taken orally per day for 12 weeks
干预措施: Placebo (Drug)
Lumateperone
42mg (two 21mg capsules) lumateperone (Caplyta) taken orally per day for 12 weeks
干预措施: Lumateperone (Drug)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: Week 0, Week 6, and Week 12
Participant Body Mass Index will be measured by standard methods
Waist Circumference
时间窗: Week 0, Week 6, and Week 12
Participant Waist Circumference will be measured by standard methods
Body Composition - Fat Mass
时间窗: Week 0 and Week 12
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat mass will be measured in grams.
Body Composition - Fat Percentage
时间窗: Week 0 and Week 12
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat Percentage will be calculated as fat mass (in grams) divided by total mass (in grams).
Body Composition - Total Body Mass
时间窗: Week 0 and Week 12
Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Total Body Mass will be measured in grams.
HBA1C
时间窗: Week 0 and Week 12
Participant HBA1C will be measured using standard labs
LDL Particle
时间窗: Week 0 and Week 12
LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Small LDL Particle
时间窗: Week 0 and Week 12
Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Large HDL Particle
时间窗: Week 0 and Week 12
Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Large VLDL Particle
时间窗: Week 0 and Week 12
Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Fasting Insulin
时间窗: Week 0, Week 6, and Week 12
Participant Fasting Insulin will be measured using standard labs
次要结局
- Positive and Negative Symptoms Scale (PANSS)(Week 0, Week 6, and Week 12)
- Calgary Depression Scale (CDRS)(Week 0, Week 6, and Week 12)
- Clinical Global Impression - Severity Scale (CGI-S)(Week 0, Week 6, and Week 12)
- Clinical Global Impression - Improvement Scale (CGI-I)(Week 0, Week 6, and Week 12)
- Insomnia Severity Index (ISI)(Week 0, Week 6, and Week 12)
- Henrichs Carpenter Quality of Life Scale (QLS)(Week 0, Week 6, and Week 12)
研究者
Xiaoduo Fan, MD, MPH
Director, UMass Mind
University of Massachusetts, Worcester