Clinical trial NCT01533519: A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)
Official title: A Dose Escalation Study of Intranasal Neuropeptide Y in PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder
Keywords: Neuropeptide Y
Intranasal Administration
PTSD
Trauma
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Men and women, age 18-60.
* Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document. We determine whether they have a sufficient understanding of the study procedures and risks by asking them to explain what's involved in the study and to give examples of study risks and benefits.
* Participants must fulfill DSM-IV criteria for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS).
* CAPS score must be at least 40 (moderate PTSD severity) at screening.

Exclusion Criteria:

* Current, primary Axis I disorders other than PTSD.
* History or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder).
* Current diagnosis of anorexia nervosa or bulimia nervosa.
* Women who are pregnant or are breast-feeding.
* Drug or alcohol abuse or dependence within the preceding 3 months.
* poorly controlled hypertension (manifest by SBP \> 140 and/or DBP \> 90); HR \< 60 or \> 100 at rest at the time of screening and confirmed immediately prior to randomization
* Evidence of coronary artery disease as evidenced by history, abnormal ECG, typical symptoms
* History of arrhythmia, cardiac surgery, or family history of sudden death
* Hepatic dysfunction as defined by AST and ALT \> 2x URL, or alkaline phosphatase and bilirubin \> 1.5 x URL within X days prior to randomization
* Chronic renal disease as defined by serum creatinine \> 1.9
* Any other serious or unstable clinically significant abnormal findings of laboratory parameters, physical examination, or ECG as determined by the PI.
* Any other serious or unstable condition that would put the subjects at undue risk as determined by the PI or additional safety monitor.
* Serious and imminent suicidal or homicidal risk.
* Psychotropic medication that will not be tapered off at least 7 days prior to screening; withdrawal symptoms must be absent at the time of screening
* History of nasal disorders or sinonasal surgery, or significant nasal abnormalities based on nasal exam.
* Received investigational intervention within 30 days prior to randomization

Primary outcomes:
measure: Patient Rated Inventory of Side Effects (PRISE)
timeFrame: baseline and within 2 hours of administration of NPY
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: baseline and within 2 hours of administration of NPY
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: at baseline and within 2 hours of administration of NPY
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: James Murrough, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.