Long-term Observation of Participants With Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Score on Beck Depression Inventory (suicide item removed)
研究概览
简要总结
Background:
More than 12,000 people have taken part in research at the Experimental Therapeutics & Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk. Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments.
Objective:
To learn the long-term impact of depression, bipolar disorder, and suicide risk.
Eligibility:
Adults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago.
Design:
This study has 2 phases: an online phase and a telephone phase. It has no in-person or face-to-face contact.
In Phase 1, participants will fill out online surveys. They will access the surveys through the study website. The questions will focus on their current thoughts and feelings. The surveys will also ask about their current treatments for their mental health symptoms. At the end of the surveys, they will be asked if they would like to take part in Phase 2. If so, they will mark yes. Phase 2 includes a phone interview. They will be contacted by email to schedule the interview.
In Phase 2, participants will be asked more in-depth questions about how they are feeling. They will also be asked which psychiatric medicines and treatments they have used since they left NIH.
In both phases, participants can skip any questions they do not want to answer.
The online surveys will take 30 minutes to complete. The phone interview will last 1-4 hours.
The information that participants give in this study may be linked to their other NIH research records.
详细描述
Study Description: The proposal will leverage existing data on former participants with mood disorders collected in the Experimental Therapeutics and Pathophysiology Branch in order to identify predictors of long-term depressive symptoms, suicide attempts and ketamine utilization. The ETPB has collected a wealth of clinical, biologic, neuroimaging and sleep data on individuals with treatment resistant depression and bipolar disorder over the last 20 years. This study would re-contact these individuals for online and telephone assessment of current symptoms. We would then determine the ability of these clinical and biological measures to predict long-term outcomes. For individuals who do not participate in online or telephone data collection, we would like to identify incidence of premature death, including suicide, using linkage to data sources such as the National Death Index. We will also use this protocol for recruitment for in-person neurobiological studies and clinical trials of treatment resistant depression, bipolar disorder and suicide risk, both for ETPB and other branches of the NIMH IRP.
Objectives: The primary objective is to identify predictors of long-term treatment-resistant depression. The secondary and tertiary objectives are to identify predictors of long-term risk for suicide attempt and identify predictors of repeat use of ketamine, respectively
Endpoints:
Primary Endpoint: Score on Beck Depression Inventory
Secondary Endpoint: Self-reported suicide attempt after NIH study participation
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Score on Beck Depression Inventory (suicide item removed)
时间窗: Follow-up assessment
Rating of depression without assessment of suicidal ideation
次要结局
- Self-reported suicide attempt(Follow-up assessment)
- Identify predictors of death by suicide(Follow-up assessment)
- Ketamine utilization at non-NIH facility(Follow-up assessment)