The Assessment of the Safety, Efficacy, and Practicality of an Algorithm Including Amantadine, Metformin and Zonisamide for the Prevention of Olanzapine-Associated Weight Gain in Outpatients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Change From Baseline to Endpoint in Weight
研究概览
简要总结
The goal of this study is to answer the following questions:
- Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine
- Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain
- How weight gain associated with olanzapine can affect people
- Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •You must have been diagnosed with schizophrenia or schizoaffective disorder
- •You must be able to visit the doctor's office once every two weeks for three months, then once every four weeks for the next three months with a possible bi-weekly visit during the fifth month
- •If you are currently taking a medication for schizophrenia or schizoaffective disorder, you have been taking it for at least 30 days without any changes
- •If you are a female, you must have a negative pregnancy test and be using an effective method of contraception
排除标准
- •You have a diagnosis of bipolar I disorder, diabetes, very high triglyceride level (fasting triglycerides greater than or equal to 500 mg/dL), recent heart attack, stroke, uncontrolled seizures, serious infection, unstable heart disease (such as ischemic heart disease or congestive heart failure), an uncorrected narrow angle glaucoma or human immunodeficiency virus (HIV)
- •You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood
- •You have a diagnosis of an eating disorder
- •You have a history of Parkinson's Disease or any related disorders
- •You are allergic to sulfa drugs or any of the medications involved in this study
研究组 & 干预措施
Olanzapine
olanzapine plus behavioral information
干预措施: olanzapine (Drug)
Olanzapine
olanzapine plus behavioral information
干预措施: Wellness education (Behavioral)
Olanzapine + Amantadine
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
干预措施: olanzapine (Drug)
Olanzapine + Amantadine
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
干预措施: amantadine (Drug)
Olanzapine + Amantadine
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
干预措施: metformin (Drug)
Olanzapine + Amantadine
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
干预措施: zonisamide (Drug)
Olanzapine + Amantadine
Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information
干预措施: Wellness education (Behavioral)
Olanzapine + Metformin
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
干预措施: olanzapine (Drug)
Olanzapine + Metformin
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
干预措施: amantadine (Drug)
Olanzapine + Metformin
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
干预措施: metformin (Drug)
Olanzapine + Metformin
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
干预措施: zonisamide (Drug)
Olanzapine + Metformin
Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information
干预措施: Wellness education (Behavioral)
结局指标
主要结局
Change From Baseline to Endpoint in Weight
时间窗: Baseline to endpoint (22 weeks)
次要结局
- Mean Change From Baseline to Endpoint in Fasting Triglycerides(Baseline to endpoint (22 weeks))
- Mean Change From Baseline to Endpoint in Fasting Total Cholesterol(Baseline to endpoint (22 weeks))
- Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol(Baseline to endpoint (22 weeks))
- Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol(Baseline to endpoint (22 weeks))
- Mean Change From Baseline to Endpoint in Fasting Glucose(Baseline to endpoint (22 weeks))
- Mean Change From Baseline to Endpoint in Hemoglobin A1c(Baseline to endpoint (22 weeks))
- Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score(Baseline to endpoint (22 weeks))
- Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Baseline to endpoint (22 weeks))
- Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)(Baseline to endpoint (22 weeks))
- Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks(Baseline to endpoint (22 weeks))