Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01066299
Status:
UNKNOWN
Last Update Posted:
2011-11-29
First Post:
2010-02-02
Brief Title:
Influence of Oxytocin on the Startle Reflex and on Its Modulation
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Single-center Study on the Influence of Oxytocin on the Startle Reflex and on Its Modulation in Healthy Male Subjects
Status:
UNKNOWN
Status Verified Date:
2011-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oxytocin OXT is currently regarded as a crucial neuropeptide in the mediation of various human social behaviors eg social affiliation social recognition and the modulation of anxiety mood and aggression An impairment of social behavior emotional regulation as well as increased stress reactions are characteristic of several psychiatric conditions including schizophrenia social anxiety and PTSD in which there is also some evidence for OXT dysfunction The startle reflex is a basic defensive reaction that can be modulated by emotional stimuli The investigation of the startle reflex and of its modulation is a well-validated method to test stress reactions and emotional regulation These processes are impaired in the same psychiatric diseases in which OXT dysfunction was evidenced Although previous animal studies showed that the dysfunction of brain OXT systems might be implicated in startle reflex and in its modulation no study has been performed yet in human that investigated the influence of OXT administration on the startle response and on its affective modulation A first aim of this study is to investigate the influence of OXT on stress reactivity and emotional modulation in healthy humans A second aim is to develop a method for the investigation of anxiety disorders Fifty male healthy participants will be tested using a randomized double-blind placebo-controlled cross-over design in two occasions once with administration of 24 IU OXT and once with placebo using nasal sprays while performing a computer-based experiment in which emotional pictures and auditory startle probes are presented We will measure the subjects subjective ratings of the pictures as well as the facial EMG activation heart rate and electrodermal activation throughout the study This project offers a unique opportunity to study the relationship between the OXT system and basic motivational and emotional behaviors The investigation of these mechanisms is in turn greatly worthwhile not only for understanding of the neurochemical and physiological processes involved in emotional regulation but also for the comprehension of the neuroendocrine and neurophysiological mechanismsunderlying anxiety disorders In the long term it could open the possibilities of OXT as a psychobiological therapeutics of psychiatric disorders
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None