CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Low dose NPY +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00748956
NCT00748956Phase 2Completed

Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers

Dennis Charney·interventional·Posted Sep 9, 2008·Updated Aug 1, 2017

In Brief

A Phase 2 clinical trial evaluating Low dose NPY, High dose NPY, and 1 other intervention for Mood Disorder and Anxiety Disorders. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2008
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2010
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.8 years ago

Interventions

Low dose NPYdrug

50nmol, administered intranasally

High dose NPYdrug

100nmol administered intranasally

Placebodrug

placebo comparator (0nmol)) administered intranasally