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

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607970
• Other study ID #: OXT-168/11
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: May 25, 2012
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Board, University of Bonn
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers

Exclusion Criteria:

• Current or past psychiatric disease

• Current or past physical illness

• Psychoactive medication

• Tobacco smokers

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	oxytocin receptor (OXTR) polymorphism and correlation with social behavior	OXTR genotyping, social behavior testing	24 months	No

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