Influence of Oxytocin on the Startle Reflex and on Its Modulation

November 28, 2011 updated by: University of Zurich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich, Division of Psychiatry and Psychotherapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: oxitocin nasal spray
oxytocin nasal spray
Drug: Syntocinon®
single dose of OXT (24 IU)
PLACEBO_COMPARATOR: placebo
inactive nasal spray
Drug: inactive nasal spray
single dose (24 IU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety ratings assessed with the State-Trait-Inventory that will used as a covariate in the ANOVAs.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University of Basel
University of Freiburg

Investigators

  • Principal Investigator: Chantal Martin Soelch, PhD, University Hospital Zurich, Division of Psychiatry and Psychotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (ESTIMATE)

February 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXT_PSY1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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