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Clinical Trials/NCT01607970
NCT01607970
Completed
Phase 1

Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making

University Hospital, Bonn1 site in 1 country80 target enrollmentAugust 2011
InterventionsOxytocin

Overview

Phase
Phase 1
Intervention
Oxytocin
Conditions
Healthy Male Volunteers
Sponsor
University Hospital, Bonn
Enrollment
80
Locations
1
Primary Endpoint
baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
May 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
University Hospital, Bonn
Responsible Party
Principal Investigator
Principal Investigator

Rene Hurlemann

MSc MD PhD

University Hospital, Bonn

Eligibility Criteria

Inclusion Criteria

  • Healthy male volunteers

Exclusion Criteria

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Tobacco smokers

Arms & Interventions

Oxytocin

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

Intervention: Oxytocin

Placebo

intranasal application, sodium chloride solution, 3 puffs per nostril

Intervention: Oxytocin

Outcomes

Primary Outcomes

baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration

Time Frame: 24 Months

The experimental tasks started 45 min after intranasal OXT/PLC administration. The STARTLE-paradigm features 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. The startle stimulus consists of a single 50-ms burst of white noise (100 dB) with nearly instantaneous rise and was delivered binaurally via headphones during 60% of the pictures (i.e. 12 from each category) at 2 - 4 s after picture onset. We examined the baseline startle magnitude as well as the affective modulation of the startle magnitude.

Secondary Outcomes

  • moral decision making after oxytocin and placebo administration(24 months)
  • oxytocin receptor (OXTR) polymorphism and correlation with social behavior(24 months)

Study Sites (1)

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