The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16,000
- 试验地点
- 1
- 主要终点
- Eligibility for research
研究概览
简要总结
The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Experimental Therapeutics and Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. In addition the protocol will allow clinicians to gain more experience in the use of a variety of polysomnographic and high-density EEG recordings. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. Subjects may also be asked to complete questionnaires about attitudes towards research and motivation for research participation. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved ETPB protocols.
详细描述
The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols on mood and anxiety disorders at the National Institute of Mental Health (NIMH) and for the collection of natural history data. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); computed tomography (CT); electroencephalography (EEG); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Years 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Subjects ages 3 to 99 may enroll in the protocol.
- •Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. Minors will be asked to assent and their parents will sign the consent form.
排除标准
- •Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment, but not including self-help groups).
研究组 & 干预措施
Adult Patients
Adult patients with mood and anxiety disorders
Adult Healthy Volunteers
Adult Healthy Volunteers
Minor Healthy Volunteers
Minor Healthy Volunteers
Minor Patients
Minor patients with mood and anxiety disorders
Parents of Minor Healthy Volunteers
Parents and guardians of minor healthy volunteers
Parents of Minor Patients
Parents and guardians of minor patients with mood and anxiety disorders
结局指标
主要结局
Eligibility for research
时间窗: Current and historical
Evaluations of psychiatric and other medical conditions and histories to determine if the subjects are appropriate for participation in NIMH IRB approved protocols and for the collection of natural history data.
次要结局
未报告次要终点
