Linagliptin and Mesenchymal Stem Cells: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- SDF1-α (stromal cell-derived factor alpha) Concentration
研究概览
简要总结
The purpose of the present study is to gather pilot data on the effects of linagliptin on the concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in humans, and to demonstrate the feasibility of such a study in patients with psychosis in our setting.
详细描述
This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal thought disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment. The principal outcome measures will be the concentrations of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM (Diagnostic and Statistical Manual) criteria for schizophrenia.
- •Considered clinically stable, and on the same dose of antipsychotic for two weeks.
- •A score no greater than 3 on the PANSS (Positive and Negative Syndrome Scale) Conceptual Disorganization item.
- •Not taking any medications for diabetes, or any anti-inflammatories other than occasional aspirin or acetaminophen. Not taking Clozapine.
- •Age 18-45 years.
- •Can be available for regular morning appointments from 8:00 am to 10:00 am, preferably on Tuesdays, Wednesdays and Thursdays.
排除标准
- •Does not meet DSM criteria for substance abuse or dependence.
- •No serious current general medical condition, such as cancer, history of stroke or myocardial infarction, tuberculosis, HIV/AIDS, hemophilia, etc.
研究组 & 干预措施
Linagliptin patients with schizophrenia
This group will be made up of 8 participants with schizophrenia and minimal thought disorder who have been stable and taking their prescribed antipsychotics; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic treatment.
干预措施: Linagliptin (Drug)
Linagliptin control group
This group will be made up of 10 control participants with no diagnosis of mental disorder; they will have 12 weeks of treatment and week for assessment. They will receive linagliptin, 5 mg by mouth once per day.
干预措施: Linagliptin (Drug)
结局指标
主要结局
SDF1-α (stromal cell-derived factor alpha) Concentration
时间窗: Blood will be collected on the first week and then biweekly for 12 weeks.
次要结局
- CD271+ cells(Blood will be collected on the first week and then biweekly for 12 weeks.)
- DPP-4 (Dipeptidyl peptidase-4) Activity(Blood will be collected on the first week and then biweekly for 12 weeks.)
- Monocyte State(Blood will be collected on the first week and then biweekly for 12 weeks.)
- Absolute/Differential leukocyte count(Blood will be collected on the first week and then biweekly for 12 weeks.)