Intranasal Administration of Neuropeptide Y in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dennis Charney

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.