To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated patients with depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
Charité - Universitätsmedizin Berlin
Berlin, Germany
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)
The primary endpoint was the mean BOLD signal % change in an emotional paradigm, based on the emotional faces from the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) in the corticolimbic system comprising the following eight brain regions of interest: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right
Time frame: A 50 min scan, 6 hours following drug intake.
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).
The secondary endpoint was the mean BOLD signal % change in an emotional paradigm (affective picture set - OASIS task) in the corticolimbic system, consisting of eight brain regions: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right
Time frame: A 50 min scan, 6 hours following drug intake.
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