Influence of Oxytocin on the Startle Reflex and on Its Modulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Basel
University of Freiburg
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01066299
First received: February 2, 2010
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Psychiatric Disorders
Drug: Syntocinon®
Drug: inactive nasal spray

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety ratings assessed with the State-Trait-Inventory that will used as a covariate in the ANOVAs. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxitocin nasal spray
oxytocin nasal spray
Drug: Syntocinon®
single dose of OXT (24 IU)
Other Name: Syntocinon®
Placebo Comparator: placebo
inactive nasal spray
Drug: inactive nasal spray
single dose (24 IU)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066299

Contacts
Contact: Chantal Martin Soelch, PhD +41 80)44 255 ext 5280 chantal.martinsoelch@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Psychiatry and Psychotherapy Recruiting
Zurich, Switzerland, 8091
Contact: Chantal Martin Soelch, PhD    +41 (0)44 255 ext 5280    chantal.martinsoelch@usz.ch   
Sponsors and Collaborators
University of Zurich
University of Basel
University of Freiburg
Investigators
Principal Investigator: Chantal Martin Soelch, PhD University Hospital Zurich, Division of Psychiatry and Psychotherapy
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01066299     History of Changes
Other Study ID Numbers: OXT_PSY1
Study First Received: February 2, 2010
Last Updated: November 28, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
oxytocin
psychophysiology
startle
anxiety
emotion
physiology

Additional relevant MeSH terms:
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014