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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: Oxytocin

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53105
    • Department of Psychiatry, University of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male volunteers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; intranasal application, sodium chloride solution, 3 puffs per nostril	Drug: Oxytocin; Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT; Other Names: Oxytocin: Syntocinon-Spray, Novartis
Experimental: Oxytocin; 24 IU Oxytocin, intranasal application 45 min prior to the experiment	Drug: Oxytocin; Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT; Other Names: Oxytocin: Syntocinon-Spray, Novartis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration	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.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
moral decision making after oxytocin and placebo administration	The experimental tasks started 45 min after OXT/PLC administration. The moral dilemmas performed in the present study were identical to those published previously by Greene et al.(2001).	24 months
oxytocin receptor (OXTR) polymorphism and correlation with social behavior	OXTR genotyping, social behavior testing	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Investigators: Principal Investigator: Rene Hurlemann, MSc MD PhD, Department of Psychiatry, University of Bonn, Germany

Publications and helpful links

Helpful Links

• Click here for more information about the NEMO research group

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: May 25, 2012
• First Posted (Estimate): May 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 30, 2012
• Last Update Submitted That Met QC Criteria: May 25, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Oxytocin; Startle; oxytocin receptor gene; moral dilemma
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: OXT-168/11