A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)

NCT01533519 | Completed Phase 1 DMC

• 1 other identifier: GCO 11-1487
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Neuropeptide Y; Intranasal Administration; PTSD; Trauma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• State-Trait Anxiety Inventory (STAI)

  baseline and within 2 hours of administration of NPY

• Change in Beck Anxiety Inventory (BAI)

  at baseline and within 2 hours of administration of NPY

Study Arms (2)

NPY/placebo

EXPERIMENTAL

This arm gets NPY first then placebo (saline). The placebo is 0.9% USP-grade saline without NPY.

Drug: Neuropeptide Y

placebo/NPY

EXPERIMENTAL

This arm gets placebo (saline) first then NPY.

Drug: Neuropeptide Y

Interventions

Neuropeptide Y DRUG

Intranasal administration will be administered with a nasal drug delivery device.

Also known as: NPY

NPY/placebo; placebo/NPY

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• James Murrough: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 29186416 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Neuropeptide Y

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• James Murrough, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 15, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (1)