Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Blood Analysis
研究概览
简要总结
This study consists of three separate appointments including a clinical assessment (interview and questionnaires), a blood draw, a social stress test, and a brain MRI.
详细描述
This is a research study looking at the biology of mood disorders in youth. The investigator ask participants to come in for three visits. The first visit includes a diagnostic interview, some questionnaires, and a blood draw. The blood draw will take place at the Fairview Outpatient Lab. A trained technician will take about 4 teaspoons of blood from the participant's arm. This sample will be sent to Dr. Andreazza in Toronto, Ontario for further analysis. No results will be shared with the participant.
The second visit would take place at the Fairview Riverside Ambulatory Research Center (ARC). This appointment will include the Trier Social Stress Test (TSST). For this, participants will be asked to prepare a short speech for 5 minutes and deliver that speech for in front of an audience with another task to follow. This task will be videotaped. After the participant has completed the speech task, the participant will be asked to complete a number of laptop games which will test for things like attention and memory. Participants will be asked to provide 5 saliva samples throughout the course of this visit so the investigators can look at Cortisol which is a hormone naturally found in saliva. The investigators will also ask participants to complete an additional set of 5 spit samples at home during the course of a normal day and bring those back to their next appointment.
The third visit would take place at the Center for Magnetic Resonance Research (CMRR) and would include a brain MRI. The MRI scan is noninvasive and takes about 2 hours. Participants will be asked to provide a urine sample and complete a urine toxicology screen (drug test) and pregnancy test (if female) prior to the MRI scan. Participants may not participate if drug or pregnancy testing is positive. The MRI involves taking pictures of the brain, from which measures of the integrity of certain brain tissues can be derived. For the scan, participants will be asked to lie down quietly on a scanner bed. Once they are inside the scanner, it will start to take pictures. While in the scanner, participants will be doing things like resting, or listening to music.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Past history of brain damage, a seizure disorder, increased intracranial pressure, history of head trauma with loss of consciousness for >15 minutes, history of stroke, mental retardation, or other serious neurological disorder
- •MRI contraindications such as braces, metal implants, implanted medical devices, or claustrophobia
- •Intelligence quotient < 80
- •Severe or acute medical illness
- •A history of current (past 3 months) substance disorder (defined by DSM-5) with the exception of Nicotine
- •Refusal to cooperate with study procedures
- •Active suicidal ideation with intent
- •Self-injury that requires medical attention (e.g. stitches) or gets significantly worse during the course of the study
结局指标
主要结局
Blood Analysis
时间窗: Baseline
Blood samples will be analysed for mitochondrial dysfunction and resulting oxidative damage to lipids, and protein and messenger ribonucleic acid levels of inflammatory cytokines
次要结局
- Beck Depression Inventory (BDI-II)(Baseline and within 6 weeks of baseline)
- MRI Data(Up to 6 weeks after baseline)
- Saliva Cortisol(Up to 6 weeks of baseline)
- Children's Depression Rating Scale - Revised (CDRS-R)(Baseline)