This study is designed to investigate the safety of intranasal administration of NPY using a dose escalation, randomized, double-blinded, placebo-controlled crossover design in a medication-free, symptomatic PTSD group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
26
Intranasal administration will be administered with a nasal drug delivery device.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Patient Rated Inventory of Side Effects (PRISE)
Clinician-administered and safety measures will take place right before and after the administration to identify and evaluate the tolerability of each possible symptom (from baseline to within 2 hours of NPY administration).
Time frame: baseline and within 2 hours of administration of NPY
State-Trait Anxiety Inventory (STAI)
Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY
Time frame: baseline and within 2 hours of administration of NPY
Change in Beck Anxiety Inventory (BAI)
Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY
Time frame: at baseline and within 2 hours of administration of NPY
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