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Oxytocin and Emotion Processing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT02156661
First received: June 3, 2014
Last updated: July 28, 2015
Last verified: July 2015
  Purpose
The purpose of this study is to determine whether oxytocin influences emotional processing and learning of emotional and social stimuli.

Condition Intervention Phase
Healthy Males
Drug: Oxytocin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Brain activity [ Time Frame: During emotion processing ]
    fMRI


Secondary Outcome Measures:
  • Psychophysiological response [ Time Frame: During stimuli presentation ]
    Skin conductance response


Enrollment: 97
Study Start Date: May 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin

Oxytocin: Syntocinon-Spray, Novartis

intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT

Drug: Oxytocin
Placebo Comparator: Placebo
Placebo nasal spray

Detailed Description:

An effect of OXT on emotion processing and anxiety has been broadly investigated in animal studies. However, in humans, effects seem more complex.

The rationale of the study is to examine direct effects of OXT to processing and learning of emotional and social values in humans.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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
  • MRI contraindication
  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.

No Contacts or Locations Provided
  More Information

Responsible Party: Rene Hurlemann, Professor, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT02156661     History of Changes
Other Study ID Numbers: OXT-FC-14
Study First Received: June 3, 2014
Last Updated: July 28, 2015

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017