The aim of this (pilot) study is to investigate if stress affects memory and attention skills by impacting the dopamine and noradrenalinesystem.
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference in fMRI activity (measurement of brain
blood flow) during the attention/memory task between placebo and atomoxetine
session in relation to cortisol, alpha-amylase, blood pressure, heart rate and
mood after the mild stressor
Secondary outcome
Behavioural performance (reaction time, errors) on learning and attention tasks
will be compared between placebo and atomoxetine session.
Background summary
Psychiatric disorders such as depression, psychosis and addiction are serve and
costly illnesses. The causes that lead to psychiatric symptoms are not entirely
clear, although it is well known that stress plays an important role in the
development of psychiatric symptoms. It has been demonstrated previously that
stress induces memory and attention problems (a key feature of psychiatric
disorders) by lowering noradrenaline and dopamine in the brain. However, this
evidence has been demonstrated in animal studies; such findings are strongly
lacking in humans.
Study objective
The aim of this (pilot) study is to investigate if stress affects memory and
attention skills by impacting the dopamine and noradrenalinesystem.
Study design
In a 1-hour session, we will once measure the effect of mild stress on
psychological (mood) and physiological (cortisol and alpha-amylase) parameters
in 20 male participants. In the same 20 male participants, we will also measure
memory and attention-related skills using 7 tesla MRI (30 min. non-invasive)
and computerised tasks. Participants complete memory and attention-related
tasks twice; once after placebo (a fake pill) and once after atomoxetine 60mg
(oral; a safe challenge that temporarily increases noradrenaline and dopamine
in the brain). This will happen according to a double-blind (researcher and
participant) randomized cross-over design.
Intervention
During sessie 1, participant are subjected to a mild stress task. In session
two and three, a non-invasive MRI measurement will be performed on a 7 tesla
MRI system; once after placebo and once after 60mg atomoxetine.
Study burden and risks
* Participation takes time: one session of 1 hour, and two sessions of 3 hours.
* Taking a pil twice: once placebo, once atomoxetine
* Lying down in the MRI scanner for half an hour twice
* Performing on computer tasks twice.
* Filling in a questionnaire about mental health and lifestyle once
The risk of participation is deemed negligible, because atomoxetine is well
tolerated. If there are any side effects, these are mild and temporary (please
also see section 5.3 and 11 in the research protocol).
Universiteitssingel 50
Maastricht 6226NB
NL
Universiteitssingel 50
Maastricht 6226NB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Male
* No use of any psychopharmacological treatment at in the past or at time of inclusion.
* No presence of a physical/medical condition that may interfere with the study
* No contradiction for MRI
* Age between 18 and 30
* right handedness
Exclusion criteria
* Diagnosis of a psychiatric disorder (DSM-V)
* Diagnosis of a neurological disorder
* Very high (>30) or low (>18) BMI
* Current recreational drug use/dependence (CIDI)
* Current alcohol dependence (CIDI)
* High blood pressure (>150 systolic, >100 diastolic)
* Non-responders to the mild stressor in session 1
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53913.068.15 |
| OMON | NL-OMON24350 |