DRKS00024756招募中2 期
Immunological Parameters and Functional Magnetic Resonance Imaging in Seasonal Affective Disorder - Immunology and fMRI in SAD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 55 Years(—)
- 性别
- All
入选标准
- •Inclusion criteria for SAD patients
- •1. Age 20 to 55 years;
- •2. DSM-5 diagnosis of recurrent major depressive disorder with current depressive episode with seasonal pattern specifier (current seasonal depressive episode) established by diagnostic interview according to the SCID;
- •3. Global Seasonality Score = 10 on the Seasonal Pattern Assessment Questionnaire (SPAQ);
- •4. SIGH-SAD score of =20 at screening visit;
- •5. Somatic health based on history, physical examination, ECG, and laboratory screening;
- •6. No treatment of SAD in the last 6 months (especially antidepressants and light therapy);
- •7. Willingness and competence to complete the informed consent process.
- •Inclusion criteria for healthy controls (matching regarding age and sex with SAD)
- •1. Age 20 to 55 years;
- •2. Somatic and psychiatric health based on history, physical examination, ECG, laboratory screening, SCID;
- •3. Willingness and competence to complete the informed consent process.
排除标准
- •Exclusion criteria for SAD and HC
- •1. Present psychiatric disorders;
- •2. Suicidal ideations (corresponding to a score of =3 on the SIGH-SAD);
- •3. Major (unstable) medical or neurological illness;
- •4. Disallowed concomitant medication (see chapter 5.4) during the last 6 months;
- •5. Intake of nutritional supplements containing n-3 PUFA;
- •6. Bright light therapy (as antidepressant treatment) within the last 6 months;
- •7. 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-5;
- •8. Failure to comply with the study protocol or follow the instructions of the investigators;
- •9. Positive urine pregnancy test.
研究者
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