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Influence of Oxytocin on the Startle Reflex and on Its Modulation

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01066299
Enrollment
50
Registered
2010-02-10
Start date
2010-05-31
Completion date
2012-12-31
Last updated
2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric Disorders

Keywords

oxytocin, psychophysiology, startle, anxiety, emotion, physiology

Brief summary

Oxytocin (OXT) is currently regarded as a crucial neuropeptide in the mediation of various human social behaviors, e.g. 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 subject's 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.

Interventions

DRUGSyntocinon®

single dose of OXT (24 IU)

DRUGinactive nasal spray

single dose (24 IU)

Sponsors

University of Basel
CollaboratorOTHER
University of Freiburg
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* gender: male * age \> 18 years * good command of German * non-smoker

Exclusion criteria

* impaired cognitive abilities * past or current psychiatric or neurological disorder * other relevant somatic disease (including liver, kidney or heart diseases - -- allergy to preserving agents (Paraben contained in nasal spray) * other medication including hormonal and herbal medication * participation in other clinical studies within one month * impaired hearing

Design outcomes

Primary

MeasureTime frame
Eye blink response to the tones measured as the peak activity of the left musculus orbicularis oculi that will be compared between the active drug and the placebo conditions.1 year

Secondary

MeasureTime frame
Anxiety ratings assessed with the State-Trait-Inventory that will used as a covariate in the ANOVAs.1 year

Countries

Switzerland

Contacts

Primary ContactChantal Martin Soelch, PhD
chantal.martinsoelch@usz.ch+41 80)44 255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026