Major Depressive Disorder Clinical Trial
Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft
and are the current first line of pharmacological antidepressive treatment. Yet, there is a
missing link between this first molecular step in their mechanism of action and observed
clinical improvement. We have determined to establish a framework combining genuine molecular
and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human serotonergic system
in order to predict antidepressant treatment response.
Objectives:
1. To predict antidepressant treatment response from data obtained using hybrid PET/MR with
acute pharmacological challenge.
2. To discriminate healthy from depressed subjects using this paradigm.
3. To establish models connecting regional changes in occupancy of serotonin transporters
(5-HTT) following citalopram infusion, with changes in brain activation and connectivity
of major resting-state hub networks.
Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.
Materials and methods:
40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS
mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural
imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a
bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT
occupancy with drug challenge, applied after 70min, in a single session. Scanning will be
terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment
with repeated evaluation of response for 3 months.
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