Complex Dynamic Systems in Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the relationship between voice samples, heart rate, respiration, movement, galvanic skin conductance, and sleep architecture with mood states in patients with Major Depressive Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability, movement, arousal, and sleep stage data.
详细描述
Aim 1: To assess multichannel physiologic measures associated with mood disorders.
Hypothesis: The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability (RR intervals), movement, arousal, and sleep stage data.
Aim 2: To assess differences in patterns and complexity of multiple physiological measures in patients with MDD compared to healthy controls.
Hypothesis: MDD will be associated with decreased measures of complexity and increased measures of approximate entropy compared to healthy controls.
Aim 3: To assess differences in patterns and complexity of multiple physiologic measures in patients with BD compared to healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- 是
入选标准
- •Age > 18 and <
- •Meet DSM-IV criteria for MDD (n=5), BD (n=5), or healthy controls with no psychiatric diagnosis (n=5).
- •Willing and able to wear a wearable device to measure sleep parameters
- •Willing and able to provide voice samples.
- •Subjects with MDD must not be taking psychiatric medications at the time of evaluation.Subjects with BD can be taking psychiatric medications, since it is not feasible for patients with BD to be completely free of mood stabilizing medications. These medications will be limited to lithium, second generation antipsychotics.
- •Currently a patient or research participant at the DCRP or the BCRP or are healthy controls enrolled in evaluation studies.
排除标准
- •Primary sleep disorder, including restless legs syndrome, difficulties in initiating and maintaining sleep.
- •Movement disorders (e.g. Parkinson's, Huntington's, tardive dyskinesia, primary chorea).
- •Active substance abuse or dependence in the past 3 months.
- •Cardiovascular or pulmonary disease, including uncontrolled hypertension, arrhythmias, history of myocardial infarction, asthma, COPD, or pulmonary carcinoma.
- •Cardiovascular or pulmonary medications (aspirin and statins are allowable).
- •Anticonvulsants.
- •Sedative/hypnotics (e.g. benzodiazepines, eczopiclone).
- •Pregnancy.
研究者
Andrew A. Nierenberg, MD
Director of Research, Bipolar Clinic and Research Program
Massachusetts General Hospital