跳至主要内容
临床试验/NL-OMON44883
NL-OMON44883已完成不适用

ight Therapy for better Mood and Metabolic control: a randomised double-blind placebo-controlled clinical trial in patients with Type 2 Diabetes Mellitus and Depression - Light therapy for Depression and Diabetes (LiDDia)

Vrije Universiteit Medisch Centrum0 个研究点目标入组 98 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Healthy subjects (pilot studie):
  • (1) Age 18-75 years
  • (2) Physically and psychiatrically healthy, as judged by an expert panel;Patients:
  • (1) Age 18 years or older
  • (2) Type 2 Diabetes Mellitus, as judged by an expert panel
  • (3) Depression (DSM-IV)

排除标准

  • Healthy subjects (pilot studie):
  • (1) A recent history of a serious medical event, as judged by an expert panel
  • (2) Hypersensitivity to drugs used
  • (3) Pregnancy
  • (4) Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
  • (5) Individuals who are investigator site personnel directly affiliated with the study, or are immediate family;Patients:
  • (1) Recent history (<2 months ago) of, or current light therapy
  • (2) Type 1 Diabetes Mellitus
  • (3) Recent history of a serious medical event or a serious medical condition, as judged by an expert panel
  • (4) Current use of oral glucocorticoids, melatonin, or cytostatics
  • (5) Recent change in antidepressant (<1 months ago) or blood-glucose lowering (<1 months ago) medication
  • (6) Psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, and severe acute suicidality, as judged by an expert panel
  • (7) Visual Acuity <60%, severe non-proliferative or preproliferative retinopathy, photocoagulated retinopathy, proliferative retinopathy (EURODIAB grades 3,4, and 5), recent history (<6 months ago) of relevant eye surgery, relevant eye surgery scheduled in the near future, senile macula degeneration
  • (8) A history of light-induced migraine or epilepsy, or severe side effects to light therapy in the past
  • (9) Hypersensitivity to drugs used
  • (10) Pregnancy
  • (11) Shift workers
  • (12) Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
  • (13) Individuals who have previously completed or withdrawn from the experimental phase of this study
  • (14) Individuals who are investigator site personnel directly affiliated with the study, or are immediate family

研究者

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