Influence of Light Exposure on Cerebral Monoamine Oxidase A in Seasonal Affective Disorder and Healthy Controls Measured by PET
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in MAO-A specific distribution volume (MAO-A DVs) assessed with PET
研究概览
简要总结
This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. In addition the investigators aim to demonstrate the impact of light therapy on MAO-A distribution
In addition, a pilot study and a sub-study in healthy controls were performed
详细描述
This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. In addition, the investigators aim to demonstrate the impact of light therapy on MAO-A distribution by investigating patients and controls in the winter before bright light therapy, in the winter after bright-light therapy, and in the summer. Bright light therapy will be placebo controlled, randomized, and double blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Patients:
- •DSM-IV diagnosis of SAD established by diagnostic interview according to the SCID.
- •Global Seasonality Score of 10 or higher on the Seasonal Pattern Assessment Questionnaire (SPAQ)
- •Somatic health based on history, physical examination, ECG, and laboratory screening
- •Aged 18 to 55 years
- •No therapeutic treatment of SAD in the last 6 months (drugs and light therapy)
- •Willingness and competence to complete the informed consent process
- •Inclusion criteria for healthy controls:
- •Aged 18 to 55 years
- •Somatic and psychiatric health based on history, physical examination, ECG, laboratory screening, SCID
- •Willingness and competence to complete the informed consent process
排除标准
- •for patients and healthy controls:
- •Concomitant major medical or neurological illness
- •Concomitant psychiatric disorders
- •Current smoking
- •Ingestion of antidepressants or other psychotropic agents targeting the serotonergic system, within the last 6 months.
- •Bright light therapy within the last 6 months.
- •Current substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to the DSM-IV.
- •Failure to comply with the study protocol or follow the instructions of the investigators.
- •Positive urine pregnancy test.
- •For participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 20 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at).
研究组 & 干预措施
Light Therapy
One subgroup of SAD patients and healthy controls respectively will receive bright light therapy using an artificial white light source (PhysioLight LD220 by DAVITA®, www.davita.de/shop/lichttherapiegeraete/lichtduschen-tageslicht/physiolight-ld-220.html) with full-spectrum 10.000lux light intensity. The treatment will be applied 30min per day at a distance of about of 50cm, preferably in the morning, during 3 weeks.
干预措施: Light Therapy (Other)
Placebo Light
The second subgroup of the SAD patients and healthy controls will receive a non-biologically active light source (<400nm or >500nm). Here, the lamp will have largely similar shape and size as compared to the therapeutic device, but the fluorescent tube with the high light intensity will be replaced by an ordinary bulb.
干预措施: Placebo Light (Other)
结局指标
主要结局
Change in MAO-A specific distribution volume (MAO-A DVs) assessed with PET
时间窗: PET2 (3 weeks after PET1) compared to PET 1 (baseline), PET3 (6 months after PET1) compared to PET 1 (baseline) and PET 2 (3 weeks after PET1)
次要结局
未报告次要终点
研究者
Rupert Lanzenberger
Assoc. Prof. PD Dr. Rupert Lanzenberger, MD
Medical University of Vienna