Influence of Oxytocin on the Startle Reflex and on Its Modulation

NCT01066299 | Unknown DMC

• 1 other identifier: OXT_PSY1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorders

Keywords

oxytocin; psychophysiology; startle; anxiety; emotion; physiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety ratings assessed with the State-Trait-Inventory that will used as a covariate in the ANOVAs.

  1 year

Study Arms (2)

oxitocin nasal spray

EXPERIMENTAL

oxytocin nasal spray

Drug: Syntocinon®

placebo

PLACEBO COMPARATOR

inactive nasal spray

Drug: inactive nasal spray

Interventions

Syntocinon® DRUG

single dose of OXT (24 IU)

oxitocin nasal spray

inactive nasal spray DRUG

single dose (24 IU)

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• University of Basel: collaborator
• University of Freiburg: collaborator

Study Sites (1)

University Hospital Zurich, Division of Psychiatry and Psychotherapy

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Anxiety Disorders

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chantal Martin Soelch, PhD

  University Hospital Zurich, Division of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Martin Soelch, PhD

CONTACT

+41 80)44 255; chantal.martinsoelch@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 10, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

CH (1)