Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
2014年1月29日 更新者：Charles Nguyen、Southern California Institute for Research and Education
The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.
研究概览
研究类型
介入性
注册 (预期的)
15
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
Long Beach、California、美国、90822
- 招聘中
- VA Long Beach
-
接触：
- Susan Shakib, Pharm.D.
- 电话号码：4564 562-826-8000
- 邮箱：susan.shakib@va.gov
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
INCLUSION CRITERIA:
- Patients currently on atypical antipsychotics
- The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.
- Patient agreeable to follow up with provider at the scheduled appointments at week 1, week 2, week 4, week 8, week 12 and week 16 after initiation of medication.
EXCLUSION CRITERIA:
- Pregnancy in women or breastfeeding
- The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation
- Known hypersensitivity to lorcaserin
- The patient is taking another weight loss medication concurrently
- Dementia
- Age less than 18 or greater than 65
- No recent substance abuse within 3 months
- No suicidal ideation within 3 months
- Unable to give informed consent, unless patient is conserved, then the conservator can provide informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lorcaserin with intensive diet counseling
Patients will be taking lorcaserin 10mg tablet by mouth twice daily.
In addition, patients will be provided with intensive dietary counseling to promote weight loss.
|
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
其他名称：
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight loss
大体时间：initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
The primary objective of this study is to evaluate the effectiveness of lorcaserin for weight loss management in patients on an antipsychotic agent.
Will monitor the weight of the patient for evaluation.
|
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of glucose control
大体时间：At initial visit and at week 12 of the study
|
Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels
|
At initial visit and at week 12 of the study
|
|
Evaluation of cravings
大体时间：initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
Using various questionnaires to evaluate cravings of various foods.
|
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
|
Monitoring of mood
大体时间：At initial visit, then at week 4 and week 12 of the study
|
Using standard questionnaires to evaluate mental health.
|
At initial visit, then at week 4 and week 12 of the study
|
|
Evaluation of systolic blood pressure
大体时间：initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
|
|
Evaluation of diastolic blood pressure
大体时间：initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
|
|
Evaluation of pulse
大体时间：initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
|
|
Evaluation of body-mass index (BMI)
大体时间：initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
|
|
Evaluation of waist circumference
大体时间：initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
|
|
|
Evaluation of cholesterol control
大体时间：At initial visit and at week 12 of the study
|
Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)
|
At initial visit and at week 12 of the study
|
|
Evaluation of electrolytes
大体时间：At initial visit and at week 12 of the study
|
Will monitor basic metabolic panel
|
At initial visit and at week 12 of the study
|
|
Evaluation of liver
大体时间：At initial visit and at week 12 of the study
|
Will monitor liver enzymes
|
At initial visit and at week 12 of the study
|
|
Evaluation of blood count
大体时间：At initial visit and at week 12 of the study
|
Will monitor blood count
|
At initial visit and at week 12 of the study
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (预期的)
2015年7月1日
研究注册日期
首次提交
2013年10月8日
首先提交符合 QC 标准的
2013年10月9日
首次发布 (估计)
2013年10月14日
研究记录更新
最后更新发布 (估计)
2014年1月30日
上次提交的符合 QC 标准的更新
2014年1月29日
最后验证
2014年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.