Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
This study has been completed.
Sponsor:
University Hospital, Bonn
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
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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
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 May 22, 2013