MedDataX Logo

Influence of Oxytocin on the Startle Reflex and on Its Modulation

NCT ID: NCT01066299

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychiatric Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

oxytocin psychophysiology startle anxiety emotion physiology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

oxitocin nasal spray

oxytocin nasal spray

Group Type EXPERIMENTAL

Syntocinon®

Intervention Type DRUG

single dose of OXT (24 IU)

placebo

inactive nasal spray

Group Type PLACEBO_COMPARATOR

inactive nasal spray

Intervention Type DRUG

single dose (24 IU)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Syntocinon®

single dose of OXT (24 IU)

Intervention Type DRUG

inactive nasal spray

single dose (24 IU)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Basel

OTHER

Sponsor Role collaborator

University of Freiburg

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chantal Martin Soelch, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Psychiatry and Psychotherapy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Zurich, Division of Psychiatry and Psychotherapy

Zurich, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chantal Martin Soelch, PhD

Role: CONTACT

Phone: +41 80)44 255

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chantal Martin Soelch, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OXT_PSY1

Identifier Type: -

Identifier Source: org_study_id