NCT02091817

Brief Summary

The purpose of this study is to determine whether oxytocin affect face perception

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started Nov 2013

Longer than P75 for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

3.1 years

First QC Date

January 26, 2014

Last Update Submit

July 1, 2015

Conditions

Keywords

oxytocinfacememory

Outcome Measures

Primary Outcomes (1)

  • Memory performance

    At the day participants will administer the substance, they will view a set of faces, of which they will be tested about 24 hours later. The measures that will be tested are %accuracy and %dwell time of eye movements towards each region in the faces the participants saw.

    Day 2 (24 hours after encoding)

Secondary Outcomes (1)

  • Mood measurement

    Day 1 (after oxytocin/placebo uptake)

Study Arms (2)

Control group

OTHER

Control group will be administered oxytocin and placebo, in a double-blind randomized order.

Drug: OxytocinDrug: Placebo

congenital prosopagnosia

EXPERIMENTAL

Congenital prosopagnosics will be administered oxytocin and placebo in a double-blind randomized order.

Drug: OxytocinDrug: Placebo

Interventions

Intervention will be examined on control group, and on experimental group as well.

Also known as: syntocinon
Control groupcongenital prosopagnosia

Placebo will be given to control group and experimental group as well.

Control groupcongenital prosopagnosia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal or corrected to normal vision

You may not qualify if:

  • minors
  • pregnancy (according to a pregnancy test taken by subjects prior to participation)
  • a history of asthma or nasal polyps
  • cardiac disorders
  • hyponatremia
  • acute or chronic renal insufficiency
  • liver cirrhosis
  • neurological disease
  • other chronic disease
  • dementia, or lack of judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka medical center

Beersheba, Israel, Israel

Location

Related Publications (7)

  • Avidan G, Behrmann M. Functional MRI reveals compromised neural integrity of the face processing network in congenital prosopagnosia. Curr Biol. 2009 Jul 14;19(13):1146-50. doi: 10.1016/j.cub.2009.04.060. Epub 2009 May 28.

    PMID: 19481456BACKGROUND
  • Avidan G, Behrmann M. Implicit familiarity processing in congenital prosopagnosia. J Neuropsychol. 2008 Mar;2(1):141-64. doi: 10.1348/174866407x260180.

    PMID: 19334309BACKGROUND
  • Avidan G, Hasson U, Malach R, Behrmann M. Detailed exploration of face-related processing in congenital prosopagnosia: 2. Functional neuroimaging findings. J Cogn Neurosci. 2005 Jul;17(7):1150-67. doi: 10.1162/0898929054475145.

    PMID: 16102242BACKGROUND
  • Behrmann M, Avidan G, Marotta JJ, Kimchi R. Detailed exploration of face-related processing in congenital prosopagnosia: 1. Behavioral findings. J Cogn Neurosci. 2005 Jul;17(7):1130-49. doi: 10.1162/0898929054475154.

    PMID: 16102241BACKGROUND
  • Hasson U, Avidan G, Deouell LY, Bentin S, Malach R. Face-selective activation in a congenital prosopagnosic subject. J Cogn Neurosci. 2003 Apr 1;15(3):419-31. doi: 10.1162/089892903321593135.

    PMID: 12729493BACKGROUND
  • MacDonald E, Dadds MR, Brennan JL, Williams K, Levy F, Cauchi AJ. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrinology. 2011 Sep;36(8):1114-26. doi: 10.1016/j.psyneuen.2011.02.015. Epub 2011 Mar 23.

    PMID: 21429671BACKGROUND
  • Avidan G, Tanzer M, Hadj-Bouziane F, Liu N, Ungerleider LG, Behrmann M. Selective dissociation between core and extended regions of the face processing network in congenital prosopagnosia. Cereb Cortex. 2014 Jun;24(6):1565-78. doi: 10.1093/cercor/bht007. Epub 2013 Jan 31.

    PMID: 23377287BACKGROUND

MeSH Terms

Conditions

ProsopagnosiaFacies

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

AgnosiaPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Shelef Ilan, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR
  • Galia Avidan, Ph.D

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of medical imaging at Soroka University Medical Center

Study Record Dates

First Submitted

January 26, 2014

First Posted

March 19, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

July 2, 2015

Record last verified: 2015-07

Locations