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Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers

NCT00748956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-08-01

Study results available
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Summary

There is growing evidence that neuropeptides act as neuronal messengers in the brain and have diverse functions that may include the regulation of mood and behavior. For example, neuropeptide Y (NPY) is thought to play a role in the adaptive stress response. The therapeutic application of neuropeptides for psychiatric disorders has been limited by difficult and unreliable penetration of the blood-brain barrier (BBB). However, recent data suggest that intranasal administration may provide a means of effectively delivering some of these neuropeptides to the brain. Thus far it is unclear if this is the case for NPY. The aims of this project are:

1. To evaluate, in 15 healthy male volunteers aged 25-45, the effect of intranasal NPY administration (0, 50 and 100 nmol) on its levels in cerebrospinal fluid (CSF), measured by means of lumbar puncture using an intraspinal catheter between L4 and L5, and in plasma, measured using an intravenous catheter in the forearm. One of the three treatments will be administered to each participant in a double-blind fashion. The 0 nmol condition will serve as the placebo control.
2. To test the effect of intranasal NPY administration on mood and anxiety.

Conditions

  • Mood Disorder
  • Anxiety Disorders

Interventions

DRUG

Low dose NPY

50nmol, administered intranasally

DRUG

High dose NPY

100nmol administered intranasally

DRUG

Placebo

placebo comparator (0nmol)) administered intranasally

Sponsors & Collaborators

  • Dennis Charney

    lead OTHER

Principal Investigators

  • Adriana Feder, MD · Icahn School of Medicine at Mount Sinai

  • Dennis Charney, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-12-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748956 on ClinicalTrials.gov