Neural Correlates of Stress and Perceived Control in Adolescent Depression
研究概览
详细说明
Participants in this research will include 40 female adolescents, aged 14-18, with Major Depressive Disorder (MDD) and 40 healthy adolescents from the greater Boston area by Dr. Emily Belleau, at McLean Hospital's Center for Depression, Anxiety and Stress Research.
The study will include four sessions:
- A clinical diagnostic interview as well as filling out a series of questionnaires and assessments.
- The second session will include a functional magnetic resonance imaging (fMRI) brain scan to be conducted at the McLean Hospital Imaging Center. Participants will be asked to respond to surveys on their cell phone in the week following the fMRI brain scan.
- The third session will include a diagnostic interview, assessments, and questionnaires to be completed three-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the week following this three month follow-up session.
- The fourth session will include a diagnostic interview, assessments, and questionnaires to be completed six-months after the fMRI brain scan. Participants will be asked to complete surveys on their cell phone during the week following this six month follow-up session.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Emily L Belleau, PhD
- 电话号码:6178554245
- 邮箱:ebelleau@mclean.harvard.edu
学习地点
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Massachusetts
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Belmont、Massachusetts、美国、02478
- 招聘中
- Mclean Hospital
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接触:
- Emily L Belleau, PhD
- 电话号码:617-855-4245
- 邮箱:ebelleau@mclean.harvard.edu
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首席研究员:
- Emily L Belleau, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Inclusion Criteria: All Participants
- Females of all ethnic origins See Section: Inclusion of Women and Minorities);
- Ages 14-18 (See Section: Inclusion of Children);
- Written informed assent/consent from adolescent and parent/guardian (if under age 18);
- English as a first language or English fluency;
- Right handed111;
- Personal cell-phone (for Ecological Momentary Assessment [EMA]) 7 All participants will be in the follicular phase of their menstrual cycle when completing the functional magnetic resonance imaging (fMRI) study session
Inclusion Criteria: MDD Sample
- Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS)
- Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants);
Inclusion Criteria: Healthy Control (HC) Sample
- No history or current diagnosis of any DSM-5 psychiatric or substance/alcohol-related disorder (as diagnosed with the KSADS)
- No first-degree relatives with a history of depression, bipolar disorder, or psychosis
Exclusion Criteria:
Exclusion Criteria: All Participants
- History of head trauma with loss of consciousness;
- History of seizure disorder;
- Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
- History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);
- History of use of dopaminergic drugs (including methylphenidate);
- Use of hormonal replacement therapy, anabolic steroids, or hormonal contraception;
- Clinical or laboratory evidence of hypothyroidism;
- Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow;
- Failure to meet standard exclusion criteria for fMRI scanning (e.g., claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other metal objects in the body);
- Pregnancy
- Testing positive on a drug test on the day of the scan which testis for stimulants, marijuana, barbiturates, benzodiazepine, buprenorphine, 3,4-Methyl enedioxy methamphetamine (MDMA), methadone, opiates, oxycodone, phencyclidine;
- History of electroconvulsive therapy
- Participants with suicidal ideation where study participation is deemed unsafe by the study clinician;
Additional Exclusion Criteria: Major Depressive Disorder (MDD) Sample
1. Major depressive disorder diagnosis secondary to another disorder (selected comorbid anxiety disorders such as generalized anxiety disorder, specific phobia, and social anxiety disorders are allowed if they are secondary to MDD)
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Computer Task Manipulation
Participants will complete computer tasks while undergoing an fMRI brain scan
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Participants will complete computer tasks.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Blood-Oxygen-Level-Dependent Imaging (BOLD) activation of the ventral striatum and ventral medial prefrontal cortex
大体时间:1.5 hour long scan during session 2
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BOLD activation of frontostriatal regions in response to computer tasks performed during the fMRI Brian scan
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1.5 hour long scan during session 2
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cortisol Rating
大体时间:collected as part of 1.5 hour long scan during session 2
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Saliva rating to be collected throughout the fMRI brain scan
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collected as part of 1.5 hour long scan during session 2
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Mood Rating
大体时间:collected as part of 1.5 hour long scan during session 2
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Self-reported mood rating to be collected throughout the fMRI brain scan
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collected as part of 1.5 hour long scan during session 2
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Stress Reactivity Score
大体时间:Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Stress Reactivity Survey Item collected via smart-phone delivered ecological momentary assessment
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Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Stress Reactive Rumination Score
大体时间:Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Stress Reactive Rumination Scale collected via smart-phone delivered ecological momentary assessment
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Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Positive Affect Score
大体时间:Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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Positive Affect Survey Items collected via smart-phone delivered ecological momentary assessment
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Longitudinal, three time points (baseline, 3-month follow-up, 6-month follow-up)
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合作者和调查者
调查人员
- 首席研究员:Emily L Belleau, PhD、Mclean Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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