Somatic Depression in the Picture; a fMRI study comparing depression in patients with chronic kidney disease and depression in a regular outpatient populatio
- Conditions
- 10027946depression with CKDdepression10038430
- Registration Number
- NL-OMON39023
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
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
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters are structural differences on MRI scans and signal change<br /><br>in fMRI BOLD response to reward, self-evaluation and emotion regulation<br /><br>processes as well as behavioural differences between groups in terms of<br /><br>percentages correct and reaction times regarding the experimental tasks. </p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>