This study aims to assess impairments in cognition and psychiatric function in ileal NET patients and relate this to 5-HT metabolism, by investigating the relation between psychiatric and cognitive function of ileal M1 NET patients to peripheral 5-…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
cognitieve stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the severity of cognitive dysfunction and depressive symptoms in
ileal NET patients and to relate this to peripheral 5-HT production.
Secondary outcome
- To assess the prevalence of formal psychiatric diagnoses (depressive
disorder, anxiety disorder) in patients with metastatic ileal NET and relate
this to peripheral 5-HT production
- To assess the severity of irritability and anger in patients with metastatic
ileal NET and to relate this to peripheral 5-HT production.
- To identify subgroups of patients with metastatic ileal NET that are more
vulnerable for depressive symptoms (e.g. with a (family) history of depression
or a polymorphism in serotonin transporter genes).
- To assess the prevalence of cognitive problems on specific domains in
patients with metastatic ileal NET and relate this to peripheral 5-HT
production.
- To assess the emotional bias in NET patients and to relate this to 5-HT
production, depressive symptoms and irritability
- To assess the association between psychiatric symptoms and cognitive
impairment and peripheral 5-HT production.
- To assess the quality of life of the patients and to relate this to
peripheral 5-HT
Background summary
Patients with neuroendocrine tumours (NET) report cognitive problems and
psychiatric symptoms such as depressed mood, anxiety and irritability. These
problems and symptoms are thought to be related to cerebral shortage of the
serotonin precursor tryptophan, that is depleted by peripheral overproduction
by the tumour. The clinical manifestation of serotonin (5-HT) overproduction
(diarrhoea, flushes and wheezing) is known as carcinoid syndrome (CS) which can
be present in metastasized (M1) ileal NET tumours. The exact role of 5-HT
metabolism in psychopathology, however, is still unclear.
Study objective
This study aims to assess impairments in cognition and psychiatric function in
ileal NET patients and relate this to 5-HT metabolism, by investigating the
relation between psychiatric and cognitive function of ileal M1 NET patients to
peripheral 5-HT production.
The study has two main objectives: First, to study the relation between
cognitive function and peripheral 5-HT production. Second, to study the
relation between the severity of depressive symptoms and peripheral 5-HT
production.
Secondary objectives are to assess psychiatric diagnoses within the patient
group and relate them to 5-HT production and to assess the severity of
irritability and its relation to 5-HT production.
Study design
observational study
Study burden and risks
The risks of this study are negligible. The burden of the study is one site
visit to the hospital. 2 extra blood samples will be taken during the blood
sample withdrawal as part of the standard care. 24 hour urine sample is extra
and will be done by the patient during the 24 hours prior to hospital visit.
During the hospital visit questionnaires, neuropsychological testing and
psychiatric evaluation will take place. The estimated time for the evaluation
is 2 * hours.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with ileal NET with metastatic disease, diagnosed between 2012 and 2017
- Signed informed consent
Exclusion criteria
- No sufficient understanding of the Dutch language.
- A previous cerebro vascular accident (assessed through review of the chart and checked with the patient)
- Severe cognitive problems such as a dementia.
- Delirium in the past 3 months
- Use of 5-HT modulating medication, such as SSRIs or SNRIs, or tryptophan
- Current chemotherapy, or chemotherapy in the past 5 years
- Previous malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin.
- Life expectancy shorter than 3 months
- Patients with a primary psychotic disorder (schizophrenia)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61238.031.17 |