Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in metabolic syndrome components
研究概览
简要总结
Background: Most psychotropic medications that are effective in the treatment of Bipolar Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no long-term study in BD that has examined specifically the association of inflammation with EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults with BD who are being started on a medication ; 2) to compare change in EMCs in youth and adults treated for BD; 3) to measure change in EMCs associated with use of different medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are associated with EMCs will be measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Diagnosis of BD type I, II, or NOS as determined by DSM-IV diagnostic criteria (confirmed using SCID or K-SADS)
- •Both females and males, age14 to 65 years
- •Decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic
- •Able to understand and comply with requirements of the study
- •Proficient in English.
排除标准
- •A primary psychiatric disorder other than bipolar disorder I, II or NOS (comorbid Axis I or II disorders are permitted, as long as clinician judges that bipolar disorder is the primary condition)
- •Initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit
- •Patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit
- •Significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics
- •Patients who are receiving pharmacological treatment for diabetes mellitus (DM), hyperlipidemia, or obesity
- •Acute or chronic medical illness (e.g. urinary tract infection, bronchitis, rheumatoid arthritis) that, as judged by the investigator, would significantly alter inflammatory, metabolic, or endocrine indices
- •Screening bloodwork that identifies any other clinically significant deviation from the reference range in clinical laboratory test results, as judged by the investigator.
结局指标
主要结局
Change in metabolic syndrome components
时间窗: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit
i.e. weight glucose, lipids, blood pressure, etc.
次要结局
- Cytokines, Chemokines, Insulin, Prolactin, Thyroid Hormone(Screening, week 4/visit 2, week 12/visit 3, week 52/final visit)
研究者
Dr. Ayal Schaffer
Head, Mood & Anxiety Disorders Program; Deputy Psychiatrist-in-Chief, Department of Psychiatry; Associate Professor, University of Toronto
Sunnybrook Health Sciences Centre