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临床试验/NL-OMON39023
NL-OMON39023已完成不适用

Somatic Depression in the Picture; a fMRI study comparing depression in patients with chronic kidney disease and depression in a regular outpatient population - Somatic depression in the picture

niversitair Medisch Centrum Groningen0 个研究点目标入组 112 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
112

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Inclusion criteria for all groups are:
  • - Age > 18 yr
  • - signing informed consent form ;Depression in patients with chronic kidney disease (CKD):
  • - Predialysis patients or patients receiving either hemodialysis (HD) or peritoneal dialysis (PD) treatment
  • - Medical condition sufficient to participate as established by physician.
  • - Severity of depression established with BDI II, a score of 14 or more (mild-depression).;Non-depressed patients with CKD:
  • - Predialysis patients or patients receiving either HD or PD treatment
  • - Medical condition sufficient to participate as established by physician.
  • - No history of a previous or current depression
  • - Having a total BDI score lower than 14 ;Regular depression:
  • - Having a total BDI score of 14 or more. ;Healthy controls:
  • - Not fulfilling any of the above criteria

排除标准

  • General exclusion criteria:
  • I) Current neurological problems that may interfere with task performance, determined by questions
  • II) Use of drugs that may influence the task performance: We primarily aim at including patients without any psychotrophic medication. If we find out during the study that there are not enough medication free patients to include in the study, we will try to match the participants in the non-CKD depression group on antidepressant and benzodiazepine use with participants in the CKD depression group.
  • III) Not being able to communicate in Dutch
  • IV) In case participants report concrete suïcidal plans in the MINI-SCAN interview a psychiatric advisor will be contacted by the interviewer. If the advisor confirms that the suicidal ideation is clinically relevant, the researcher will advise the participant to seek treatment and ask the participant permission to inform the participants psychiatrist or general practitioner (controls).The participant will be excluded from participating in the study. ;V) Due to the use of MRI scanning, the following additional criteria will apply:
  • The participants will have to fill out a detailed questionnaire covering safety aspects of the research in relation to the 3 Tesla magnetic field and the MRI environment.
  • These criteria are:
  • - MR incompatible implants in the body (such as ear prothesis or other metal implants)
  • - Any risk of having metal particles in the eyes due to manual work without proper eye protections
  • - Tattoos containing red pigments
  • - (Suspected) Pregnancy
  • - Claustrophobia
  • - The refusal to be informed of structural brain abnormalities that could be detected during the experiment ;Specific exclusion criteria per experimental group:
  • Depression in patients with CKD:
  • - Presence of any life-time and current psychiatric disorder, excluding nicotine dependence or history of alcohol dependence / abuse, any lifetime Anxiety Disorder and MDD in patients on HD as established by: I)Screening questions and eligible sections from MINI-scan interview
  • II)Questions on the use of psychotropic medication (antidepressive / anti-psychotic or sedative medication)
  • III)And, if possible, confirmation of this with information from the UMCG medical record ;Non-depressed patients with CKD:
  • -Presence of any life-time and current psychiatric disorder, excluding nicotine dependence or history of alcohol dependence / abuse, as established by the screening questions and eligible sections from the MINI-SCAN interview and a BDI score > 13.;Regular depression:
  • -Presence of any life time and current psychiatric disorder as diagnosed with the MINI scan, except MDD, nicotine dependence or history of alcohol dependence / abuse, any lifetime (not current) Anxiety Disorder (GAD) as established by:
  • I)Screening questions and eligible sections from the MINI-SCAN interview
  • II)Questions on the use of psychotropic medication (antidepressive / anti-psychotic or sedative medication)
  • III)And, if possible, confirmation of this with information from the UMCG medical record
  • -Any cardiovascular disease, (MI, heart failure, CVA, serious stenosis of a major vessel) or end-stage renal disease as indicated in a self report inventory. ;Healthy controls:
  • -Presence of any Life-time and current psychiatric disorder excluding nicotine dependence or history of alcohol dependence / abuse, as established by the screening questions and el

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