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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01607970
First received: May 23, 2012
Last updated: May 25, 2012
Last verified: May 2012

May 23, 2012
May 25, 2012
August 2011
May 2012   (final data collection date for primary outcome measure)
baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01607970 on ClinicalTrials.gov Archive Site
  • moral decision making after oxytocin and placebo administration [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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).
  • oxytocin receptor (OXTR) polymorphism and correlation with social behavior [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    OXTR genotyping, social behavior testing
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy Male Volunteers
Drug: Oxytocin
Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT
Other Name: Oxytocin: Syntocinon-Spray, Novartis
  • Experimental: Oxytocin
    24 IU Oxytocin, intranasal application 45 min prior to the experiment
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    intranasal application, sodium chloride solution, 3 puffs per nostril
    Intervention: Drug: Oxytocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Tobacco smokers
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01607970
OXT-168/11
No
Rene Hurlemann, University Hospital, Bonn
University Hospital, Bonn
Not Provided
Principal Investigator: Rene Hurlemann, MSc MD PhD Department of Psychiatry, University of Bonn, Germany
University Hospital, Bonn
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP