NCT01216605

Brief Summary

The present study was designed to investigate the effects of a single dose of synthetic oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary the level of awareness. In a randomized placebo-controlled between-subject design, recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition. We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed with limited awareness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

Enrollment Period

2 months

First QC Date

October 6, 2010

Last Update Submit

October 6, 2010

Conditions

Health

Outcome Measures

Primary Outcomes (1)

  • Performance on a facial emotion recognition task

    45 min. following drug administration

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR
Drug: Syntocinon 24 IU

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Syntocinon 24 IUDRUG
Oxytocin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • to 40 years of age

You may not qualify if:

  • Any psychiatric diagnosis life-time
  • Somatic disease
  • IQ \< 85
  • Smoker
  • Psychoactive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of PSychiatry University of Rostock

Rostock, D, 18055, Germany

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Gregor Domes, PhD

    University of Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 7, 2010

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 7, 2010

Record last verified: 2010-10

Locations

DE(1)