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    A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder

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    Author
    Sayed, S; Van Dam, NT; Horn, SR; Kautz, MM; Parides, M; Costi, S; Collins, KA; Iacoviello, B; Iosifescu, DV; Mathe, AA; ...
    Date
    2018-01-01
    Source Title
    International Journal of Neuropsychopharmacology
    Publisher
    OXFORD UNIV PRESS
    University of Melbourne Author/s
    Van Dam, Nicholas
    Affiliation
    Melbourne School of Psychological Sciences
    Metadata
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    Document Type
    Journal Article
    Citations
    Sayed, S., Van Dam, N. T., Horn, S. R., Kautz, M. M., Parides, M., Costi, S., Collins, K. A., Iacoviello, B., Iosifescu, D. V., Mathe, A. A., Southwick, S. M., Feder, A., Charney, D. S. & Murrough, J. W. (2018). A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY, 21 (1), pp.3-11. https://doi.org/10.1093/ijnp/pyx109.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/253365
    DOI
    10.1093/ijnp/pyx109
    Abstract
    Background: Anxiety and trauma-related disorders are among the most prevalent and disabling medical conditions in the United States, and posttraumatic stress disorder in particular exacts a tremendous public health toll. We examined the tolerability and anxiolytic efficacy of neuropeptide Y administered via an intranasal route in patients with posttraumatic stress disorder. Methods: Twenty-six individuals were randomized in a cross-over, single ascending dose study into 1 of 5 cohorts: 1.4 mg (n=3), 2.8 mg (n=6), 4.6 mg (n=5), 6.8 mg (n=6), and 9.6 mg (n=6). Each individual was dosed with neuropeptide Y or placebo on separate treatment days 1 week apart in random order under double-blind conditions. Assessments were conducted at baseline and following a trauma script symptom provocation procedure subsequent to dosing. Occurrence of adverse events represented the primary tolerability outcome. The difference between treatment conditions on anxiety as measured by the Beck Anxiety Inventory and the State-Trait Anxiety Inventory immediately following the trauma script represented efficacy outcomes. Results: Twenty-four individuals completed both treatment days. Neuropeptide Y was well tolerated up to and including the highest dose. There was a significant interaction between treatment and dose; higher doses of neuropeptide Y were associated with a greater treatment effect, favoring neuropeptide Y over placebo on Beck Anxiety Inventory score (F1,20=4.95, P=.038). There was no significant interaction for State-Trait Anxiety Inventory score. Conclusions: Our study suggests that a single dose of neuropeptide Y is well tolerated up to 9.6 mg and may be associated with anxiolytic effects. Future studies exploring the safety and efficacy of neuropeptide Y in stress-related disorders are warranted. The reported study is registered at: http://clinicaltrials.gov (ID: NCT01533519).

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