Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making

NCT ID: NCT01607970

Last Updated: 2012-05-30

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to determine whether oxytocin affects the modulation of startle reactivity by aversive social stimuli and to investigate the oxytocin effect on moral judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR) polymorphisms on behavioral responses to social stimuli.

Detailed Description

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The neuropeptide oxytocin (OXT) can enhance the impact of positive social cues but may reduce that of negative ones, although it is unclear whether the latter causes blunted emotional responses. After OXT or placebo application participants are exposed to acoustic startle probes presented alone and during viewing of 60 color pictures mostly selected from the 'International Affective Picture System'. The paradigm featured 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. In the other part of the experiment, after intranasal OXT or placebo application participants respond to 60 moral dilemmas.

Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin

24 IU Oxytocin, intranasal application 45 min prior to the experiment

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT

Placebo

intranasal application, sodium chloride solution, 3 puffs per nostril

Group Type PLACEBO_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT

Interventions

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Oxytocin

Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT

Intervention Type DRUG

Other Intervention Names

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Oxytocin: Syntocinon-Spray, Novartis

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers

Exclusion Criteria

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Rene Hurlemann

MSc MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rene Hurlemann, MSc MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, University of Bonn, Germany

Locations

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Department of Psychiatry, University of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Related Links

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http://renehurlemann.squarespace.com/welcome/

Click here for more information about the NEMO research group

Other Identifiers

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OXT-168/11

Identifier Type: -

Identifier Source: org_study_id

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