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
  Purpose

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.


Condition Intervention Phase
Healthy Male Volunteers
Drug: Oxytocin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 80
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oxytocin: Syntocinon-Spray, Novartis
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 Name: Oxytocin: Syntocinon-Spray, Novartis

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Tobacco smokers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607970

Locations
Germany
Department of Psychiatry, University of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Rene Hurlemann, MSc MD PhD Department of Psychiatry, University of Bonn, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Rene Hurlemann, MSc MD PhD, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01607970     History of Changes
Other Study ID Numbers: OXT-168/11
Study First Received: May 23, 2012
Last Updated: May 25, 2012
Health Authority: Germany: Ethics Board, University of Bonn

Keywords provided by University Hospital, Bonn:
Oxytocin
Startle
moral dilemma
oxytocin receptor gene

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014