Influence of Oxytocin on the Startle Reflex and on Its Modulation
Primary Purpose
Psychiatric Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Syntocinon®
inactive nasal spray
Sponsored by
About this trial
This is an interventional basic science trial for Psychiatric Disorders focused on measuring oxytocin, psychophysiology, startle, anxiety, emotion, physiology
Eligibility 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
Sites / Locations
- University Hospital Zurich, Division of Psychiatry and PsychotherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oxitocin nasal spray
placebo
Arm Description
oxytocin nasal spray
inactive nasal spray
Outcomes
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.
Secondary Outcome Measures
Anxiety ratings assessed with the State-Trait-Inventory that will used as a covariate in the ANOVAs.
Full Information
NCT ID
NCT01066299
First Posted
February 2, 2010
Last Updated
November 28, 2011
Sponsor
University of Zurich
Collaborators
University of Basel, University of Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT01066299
Brief Title
Influence of Oxytocin on the Startle Reflex and on Its Modulation
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Basel, University of Freiburg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorders
Keywords
oxytocin, psychophysiology, startle, anxiety, emotion, physiology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oxitocin nasal spray
Arm Type
Experimental
Arm Description
oxytocin nasal spray
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
inactive nasal spray
Intervention Type
Drug
Intervention Name(s)
Syntocinon®
Intervention Description
single dose of OXT (24 IU)
Intervention Type
Drug
Intervention Name(s)
inactive nasal spray
Intervention Description
single dose (24 IU)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Anxiety ratings assessed with the State-Trait-Inventory that will used as a covariate in the ANOVAs.
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chantal Martin Soelch, PhD
Phone
+41 80)44 255
Ext
5280
Email
chantal.martinsoelch@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Martin Soelch, PhD
Organizational Affiliation
University Hospital Zurich, Division of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Psychiatry and Psychotherapy
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantal Martin Soelch, PhD
Phone
+41 (0)44 255
Ext
5280
Email
chantal.martinsoelch@usz.ch
12. IPD Sharing Statement
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Influence of Oxytocin on the Startle Reflex and on Its Modulation
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