Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
研究概览
简要总结
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age 18 to 65 years
- •Body mass index (BMI) >=25;
- •Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;
- •Able to give basic informed consent
- •Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.)
- •Epworth Scale Score > 7
- •Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study
排除标准
- •Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
- •Not competent to provide informed consent in the opinion of the investigator
- •Ultra-rapid cycling (>4 episodes per month) bipolar I disorder
- •Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
- •Women who are planning to become pregnant, currently pregnant, or breast-feeding;
- •Current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. If that drug screen is positive, the subject will be excluded. If the second drug screen is negative, the subject will be considered for the study;
- •Subjects who have previously failed an adequate trial of aripiprazole.
- •Subjects with a suicide attempt in the past 2 years;
- •Subjects with a history of inpatient admission in the past 1 year;
- •Subjects with a history of homicidal ideation;
- •Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.
研究组 & 干预措施
A
Aripiprazole
干预措施: Aripiprazole (Drug)
结局指标
主要结局
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
时间窗: 3 months
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
时间窗: 3 month
次要结局
- Hamilton Rating Scale for Depression(3 months)
- Quality of Life Enjoyment Questionnaire(3 months)
- Young Mania Rating Scale(3 months)
- Global Assessment of Functioning(3 months)
研究者
Holly Swartz
Professor of Psychiatry
University of Pittsburgh