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NCT00748956 · ClinicalTrials.gov registry record · Phase 2
Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers
A Phase 2 study, sponsored by Dennis Charney.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00748956: Completed Phase 2 study, sponsored by Dennis Charney.
NCT00748956 is a Phase 2 study that has completed, run by Dennis Charney. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00748956, a Phase 2 study, has completed, sponsored by Dennis Charney.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
Levels of Neuropeptide Y in the cerebrospinal fluid
Interventions
- DRUG Placebo
- DRUG Low dose NPY
- DRUG High dose NPY
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT00748956 record still lists
NCT00748956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00748956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00748956 about?
NCT00748956 is a clinical study titled "Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers". 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 neuropepti...
What is the current status of trial NCT00748956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2010-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00748956?
The interventions under investigation include: Placebo (DRUG), Low dose NPY (DRUG), High dose NPY (DRUG).
Who is sponsoring clinical trial NCT00748956?
This trial is sponsored by Dennis Charney, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00748956's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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