Seasonal Affective Disorder: Exploratory Investigation of Seasonal Variations in Brain Structure and Connectivity as a Predictor for Depressive Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Changes in neural function
研究概览
简要总结
Seasonal Affective Disorder (SAD) is a subtype of Major Depressive Disorder, characterized by a recurrent temporal relationship between the season of year, the onset and the remission of a major depressive episode. Estimates of the annual prevalence state that 1-6% of the population will develop SAD with the larger prevalences found at greater extremes in latitude. SAD is most likely triggered by the shortening photoperiod experienced in the winter months leading to a deterioration of mood. Recent cross-sectional neuroimaging studies have found cellular and neurotransmitter changes in response to seasonality, ultimately having an impact on the affect of patients. Conversly, this study aims to investigate the changes in neurocircuitry related to depression and euthymic states. Patients with SAD offer a unique ability to study these changes since they have predictable triggers for the onset of depression (i.e. the winter months) and remission (i.e. the summer months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for SAD Cohort
- •Male or female between the ages of 18 to 65 years, inclusive
- •Patients who are able and willing to give consent and able to attend study visits
- •Agreement to use light therapy for four weeks
- •DSM-V diagnosis of seasonal affective disorder, at least 2 year history of the illness with a Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version (SIGH-SAD) score ≥ 25 at screening
排除标准
- •for SAD Cohort
- •Current alcohol and/or substance use disorder
- •Use of cigarettes
- •Past or present psychiatric disorders (axis I and II) other than SAD
- •Taken medications approved and/or employed off-label for depression
- •Previous use of light therapy
- •Use of photosensitive medications
- •Montreal Cognitive Assessment score < 24
- •Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc.
- •Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist) including advanced kidney disease
- •Severely impaired renal function (estimated glomerular filtration rate <30ml/min/1.73m2)
- •Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- •Pregnant and/or breastfeeding
- •Travelled to another a more southern latitude within 6 months of scan
- •Night shift workers
- •Are participating or have participated in clinical trial or research study in the last 30 days
- •Unable to communicate with investigator and/or staff
- •Diagnosis of a reading disability, dyslexia or significant learning disorder
- •Inclusion Criteria for Unipolar Depression Cohort contraindications
- •Male or female between the ages of 18 to 65 years, inclusive
- •Patients who are able and willing to give consent and able to attend study visits
- •DSM-V diagnosis of major depressive disorder, with a Hamilton Depression Rating Scale score ≥ 22 at screening
- •Exclusion Criteria for Unipolar Depression Cohort
- •Current alcohol and/or substance use disorder
- •Past or present psychiatric disorders (axis I and II) other than SAD
- •Montreal Cognitive Assessment score < 24
- •Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc.
- •Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist) including advanced kidney disease
- •Severely impaired renal function (estimated glomerular filtration rate <30ml/min/1.73m2)
- •Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- •Pregnant and/or breastfeeding
- •Are participating or have participated in clinical trial or research study in the last 30 days
- •Unable to communicate with investigator and/or staff
- •Diagnosis of a reading disability, dyslexia or significant learning disorder
- •Inclusion Criteria for Healthy Controls
- •Male or female between the ages of 18 to 65 years, inclusive
- •Patients who are able and willing to give consent and able to attend study visits
- •No current or past history of mental disorder
- •No unstable medical disorders
- •Exclusion Criteria for Healthy Controls
- •Use of any medication for a general medical disorder and/or condition that, in the opinion of the investigator, may affect neural structure
- •Alcohol or drug-use within 24 hours of MRI
- •Pregnant and/or breastfeeding
- •Montreal Cognitive Assessment score < 24
- •Patients with standard contraindications for MR imaging. For example, non-MRI compatible metallic implants including cardiac pacemaker, size limitations etc.
- •Known intolerance or allergies to MRI contrast agent (Gadolinium or Magnevist)
- •Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- •Are participating or have participated in clinical trial or research study in the last 30 days
- •Unable to communicate with investigator and/or staff
研究组 & 干预措施
Major Depressive Disorder
SAD patients will be compared to unipolar depressed patient cohort, who will be imaged in the winter and the summer.
Seasonal Affective Disorder
The primary objective is to use neuroimaging paradigms to identify perturbations in neural circuits of SAD patients when they are clinically depressed in the winter, after bright light therapy treatment, and when they are healthy in the summer
干预措施: Bright Light Therapy (Device)
Healthy Controls
SAD patients will be compared to healthy controls, who will be imaged in the winter and the summer.
结局指标
主要结局
Changes in neural function
时间窗: 12 months
Functional MRI Scan
Changes in connectivity
时间窗: 12 months
Diffusion Tensor Imaging Scan
次要结局
- Memory(12 months)
- Blood Serum Metabolomic seasonal variation(12 months)
- Depressive severity measured through the • Structured Interview Guide for the Hamilton Depression Rating Scale-SAD version(12 months)
- Executive Function(12 months)
- Concentration(12 months)
研究者
Dr. Nir Lipsman
Neurosurgeon, Scientist
Sunnybrook Health Sciences Centre