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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPY/placebo | Experimental | This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY. |
|
| placebo/NPY | Experimental | This arm gets placebo (saline) first then NPY. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropeptide Y | Drug | Intranasal administration will be administered with a nasal drug delivery device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline and within 2 hours of administration of NPY |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and within 2 hours of administration of NPY |
| Change in Beck Anxiety Inventory (BAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Murrough, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29186416 | Derived | Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathe AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009478 | Neuropeptide Y |
| ID | Term |
|---|---|
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
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Self-report behavioral measures will take place right before and after the administration to evaluate acute anxiolytic effects of intranasal administration of NPY |
| at baseline and within 2 hours of administration of NPY |
| D011506 |
| Proteins |