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

NCT01607970 | Completed Phase 1

• 1 other identifier: OXT-168/11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Male Volunteers

Keywords

Oxytocin; Startle; moral dilemma; oxytocin receptor gene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• moral decision making after oxytocin and placebo administration

  24 months

• oxytocin receptor (OXTR) polymorphism and correlation with social behavior

  24 months

Study Arms (2)

Oxytocin

EXPERIMENTAL

24 IU Oxytocin, intranasal application 45 min prior to the experiment

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

intranasal application, sodium chloride solution, 3 puffs per nostril

Drug: Oxytocin

Interventions

Oxytocin DRUG

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

Also known as: Oxytocin: Syntocinon-Spray, Novartis

Oxytocin; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Location

Related Links

• Click here for more information about the NEMO research group

MeSH Terms

Interventions

Oxytocin; lactitol

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rene Hurlemann, MSc MD PhD

  Department of Psychiatry, University of Bonn, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc MD PhD

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 30, 2012
• Study Start: August 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 30, 2012

Record last verified: 2012-05

Locations

DE (1)