A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD
Status:
Terminated
Trial end date:
2018-04-30
Target enrollment:
Participant gender:
Summary
Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in
resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron
target engagement in a group of subjects with PTSD. All subjects will be evaluated by
physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing,
and urinalysis. Results of these studies must demonstrate a lack of clinically significant
abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and
receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil
diameter during pupillometric evaluation after two weeks on each treatment will serve as the
primary outcome measure. This will be compared in the treatment groups using mixed effects
repeated measures models to evaluate if there is a significant difference in pupil size among
the treatments studied. As a secondary analysis this approach will be used to evaluate
whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will
compute correlations between pupil size and CAPS-5 scores.