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临床试验/DRKS00024756
DRKS00024756招募中2 期

Immunological Parameters and Functional Magnetic Resonance Imaging in Seasonal Affective Disorder - Immunology and fMRI in SAD

Medizinische Universität Wien0 个研究点目标入组 80 人开始时间: 2021年3月11日最近更新:
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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