Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers

Completed · Phase 2 · Has a placebo group

Conditions studied: Mood Disorder, Anxiety Disorders

In brief

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.

Key facts

Study ID

NCT00748956

Run by

Dennis Charney

People needed

10

Starts

2010-01-01

Expected to finish

2012-01-01

Last updated by the study team

2017-08-01

Who can join

Age: 25 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Men aged 25-45.
• No history of Axis I disorder as defined in the DSM-IV other than past nicotine abuse or dependence or adjustment disorder.

You may not qualify if…

• Nicotine or caffeine abuse or dependence within the preceding 3 months.
• History or complaint of nasal disorders or allergies.
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic.
• Significant obesity (BMI > 30), scoliosis, spinal stenosis or a history of lumbosacral laminectomy.
• Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG.
• Current use of any medications that have effects on CNS function.
• Prior sinonasal surgery, or significant nasal polyps as determined by nasal endoscopy.

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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