NCT00683709已完成不适用
Metabolic Side Effects, Diet and Exercise Counseling and Brain Function in a Naturalistic Clinical Trial of Clozapine for Treatment Resistant Bipolar and Schizoaffective Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Increases in BMI in subjects with BD and SA after 12 months of clozapine treatment will be smaller in subjects treated with CBT ex/diet compared with those receiving CAU.
研究概览
简要总结
Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients.
- determine if after 12 months of treatment with clozapine, the BMI changes with clients who are councelled as usual regarding weight gain while on Clozapine.
- determine if after 12 months of treatment with clozapine, the BMI changes with intense, structured councelling about diet and exercise.
详细描述
To determine whether the changes in BMI produced in subjects with Bipolar Disorder (BD) and Schizoaffective Disorder (SA) by 12 months of treatment with clozapine, can be diminished after an intense and highly structured intervention focused on diet and exercise, compared with the usual brief counseling regarding weight gain on this drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clients diagnosed with bipolar disorder or schizoaffective disorder
- •Clients who respond poorly to treatment
- •Males and females ages 18 years or older
- •Clients who have had a trial of antipsychotics, incl. at least one atypical antipsychotic plus at least 2 mood stabilizers
- •Clients who are capable of providing informed consent
排除标准
- •Clients who take carbamazepine
- •Clients with a history of extremely low white blood counts
- •Clients with severe kidney, liver or heart disease, or heart operation
- •Clients are hypersensitive to clozapine
- •Clients who have a history of serious side effects after previous treatment with clozapine
- •Clients with alcohol or drugs abuse within the last 3 months
- •Clients who have a seizure disorder
- •Clients who have metal in the head, neck or eyes, shrapnel, bullets, or body piercing, a pacemaker, brain aneurism clips, cochlear implant, hearing aid, tens unit, spinal implant, or pregnancy. These safety measures are necessary because of the magnetic fields of the MRI scan.
结局指标
主要结局
Increases in BMI in subjects with BD and SA after 12 months of clozapine treatment will be smaller in subjects treated with CBT ex/diet compared with those receiving CAU.
时间窗: 5 years
次要结局
- Adverse changes in plasma lipids, blood sugar, and fitness level will be greater in subjects treated with CBT ex/diet compared with those receiving CAU after 12 months of clozapine treatment.(5 years)
研究者
研究点 (1)
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