wetenschappelijk onderzoek met gezonde vrijwilligers healthy
Conditions
Interventions
In one session, subjects will receive 40 mg of the selective norepinephrine
reuptake inhibitor atomoxetine (Navarra, et al., 2008), orally administered.
Although other recent studies have used dosag
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy adult subjects with no history of neurological disorder/disease and no counter-indications to 3 Tesla MRI or to atomoxetine, and no personal relationship with the researchers will be included in this study. All participants will be right-handed native Dutch speakers with normal vision or contact lenses.
Exclusion criteria
Exclusion criteria: Potential participants will be prescreened for contra-indications for 3 Tesla fMRI and atomoxetine, which include metal implants, heart arrhythmia, claustrophobia, glaucoma, hypertension and use of anti-depressants or psychotropic medication and possible pregnancy (in adult females). They will additionally be prescreened for head trauma, premature birth, learning disabilities, and history of neurological or psychiatric illness. Finally, left-handed individuals will be excluded from the study because some left-handers have substantially different brain organization relative to right-handers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ~Drug intervention~ In one session, subjects will receive 40 mg of the selective norepinephrine reuptake inhibitor atomoxetine (Navarra, et al., 2008), orally administered. Although other recent studies have used dosages of 80 mg (Graf, et al., 2011), here we opt for the typical starting dose used in clinical practice, 40 mg, to avoid the reported side effects of increased heart rate at high atomoxetine doses (Heil, et al., 2002). In the other session, either one week earlier or one week later, subjects will receive a placebo pill. ~MRI data acquisition~ Functional neuroimaging will be performed at the 3T fMRI scanner of the LIBC, located in the the LUMC. One resting-state fMRI scan series will last approximately 7 minutes. For registration purposes, one T1-weighted scan will be acquired for each subject. During RS-fMRI acquisition, the cardiac and respiratory signal will be acquired using a flexible pressure belt and a pulse oximeter. In addition, pupil diameter will be concurrently measured using an EyeLink 1000 fMRI-compatible eye tracker. ~Saliva samples~ We will collect saliva using Salivette sampling devices in order to measure corticol levels and the secretion of salivary alpha-amylase, a valid biomarker for central noradrenergic activity and NE release (reviewed in Segal & Cahill, 2009). Saliva will be collected three times per session: At baseline (right before the treatment); after completing the MRI scans; and after subjects complete all tasks. Saliva samples will be stored at -20 °C after completion of the session until biochemical analysis takes place. ~Questionnaires~ The State-Trait Anxiety Inventory for Adults (Spielberger, Goruch, Lushene, Vagg & Jacobs, 1983) is a standard anxiety questionnaire that measures trait anxiety. Two reviews have identified a relationship between anxiety and NE activity (Tanaka, Yoshida, Emoto & Ishii, 2000; Howells, Stein & Russell, 2012). Tanaka and colleagues reviewed anxiety and stress man | — |
Secondary
| Measure | Time frame |
|---|---|
| n.v.t. | — |
Countries
Netherlands
Outcome results
None listed