Beyond Monoamines: The Role of the Nociceptin/Orphanin FQ Receptor in Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Salivary Cortisol
研究概览
简要总结
This study looks at the role of the Nociceptin/Orphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.
详细描述
The overarching goals of this research are to investigate: (1) the activity of the Nociceptin/Orphanin FQ receptor system among individuals with current or remitted MDD; (2) neural foundations of approach/avoidance behaviors in current or remitted MDDs; (3) stress-induced inflammation in individuals with remitted MDD; (4) neural markers that predict future disease course.
This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task, in addition to a resting positron emission tomography (PET) scan.
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
- 18 Years 至 45 Years（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
研究组 & 干预措施
MDD subjects
Subjects diagnosed with Major Depression Disorder
干预措施: Aversive stimuli (Device)
MDD subjects
Subjects diagnosed with Major Depression Disorder
干预措施: PET radiotracer (Drug)
Remitted MDD subjects
Subjects with a history of major depressive disorder episode in the past
干预措施: Aversive stimuli (Device)
Remitted MDD subjects
Subjects with a history of major depressive disorder episode in the past
干预措施: PET radiotracer (Drug)
Control subjects
Subjects with no history of known neurological and psychiatric illness.
干预措施: Aversive stimuli (Device)
Control subjects
Subjects with no history of known neurological and psychiatric illness.
干预措施: PET radiotracer (Drug)
结局指标
主要结局
Salivary Cortisol
时间窗: Baseline
For assessing stress level
Clinical Interview
时间窗: Baseline
For assessing psychological state
MRI Data
时间窗: within 30 days of Screening Visit
For testing the neural correlates of approach-avoidance decision making behaviors
PET Data
时间窗: within 30 days of Screening Visit
For assessing the Nociceptin/Oprhanin FQ receptor system activity
Follow-up Clinical Interviews
时间窗: Change from Baseline at 6 months and 12 months after the PET visit
To assess psychological state changes
Behavioral Performance on the Probabilistic Reward Task (PRT)
时间窗: Baseline
the PRT assesses individuals' ability to learn from rewards
Arterial blood data
时间窗: Baseline
for PET modeling and assessing Nociceptin/Orphanin FQ levels in bloodstream
次要结局
- Childhood Trauma Questionnaire (CTQ)(Baseline)
- Medical Outcome Survey-Short form (SF-36)(Change from Baseline at 6 months and 12 months after the PET visit)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(Change from Baseline at 6 months and 12 months after the PET visit)
- Snaith Hamilton Pleasure Scale (SHAPS)(Change from Baseline at 6 months and 12 months after the PET visit)
- Thought and Feeling Questionnaire (TFQ)(Baseline)
- Temporal Experience of Pleasure Scale (TEPS)(Change from Baseline at 6 months and 12 months after the PET visit)
- Stress and Adversity Inventory (STRAIN)(Change from Baseline at 12 months after the PET visit)
- Perceived Stress Scale (PSS)(Change from Baseline at 6 months and 12 months after the PET visit)
- PRT Post-task Questionnaire(Baseline)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline)
- Positive and Negative Affect Schedule (PANAS)(Baseline)
- Hamilton-Depression Rating Scale (HAMD-17)(Change from Baseline at 6 months and 12 months after the PET visit)
- Beck Depression Inventory-II (BDI)(Change from Baseline at 6 months and 12 months after the PET visit)
- Mood and Anxiety Symptom Questionnaire (MASQ)(Baseline)
- Cognitive-Behavioral Avoidance Scale (CBAS)(Baseline)
- Defeat Scale (DS)(Baseline)
- Questionnaire of Unpredictability in Childhood (QUIC)(Change from Baseline at 6 months and 12 months after the PET visit)
- State-Trait Anxiety Inventory (STAI)(Baseline)
- Quick Inventory of Depressive Symptomatology (QIDS)(Change from Baseline at 6 months and 12 months after the PET visit)
研究者
Diego Pizzagalli
Director, Center for Depression, Anxiety and Stress Research
Mclean Hospital