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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 is a Phase 2 study that has completed, run by Dennis Charney. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00748956
The ClinicalTrials.gov registry entry for NCT00748956 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dennis Charney, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00748956 reports 0 study locations.
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.
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