- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091817
The Effect of Oxytocin on Face Perception
July 1, 2015 updated by: Ilan Shelef, Soroka University Medical Center
The Behavioral and Neural Effects of Oxytocin on Face Perception in Congenital Prosopagnosia
The purpose of this study is to determine whether oxytocin affect face perception
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beer Sheva, Israel
- Soroka Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- normal or corrected to normal vision
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Control group
Control group will be administered oxytocin and placebo, in a double-blind randomized order.
|
Intervention will be examined on control group, and on experimental group as well.
Other Names:
Placebo will be given to control group and experimental group as well.
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Experimental: congenital prosopagnosia
Congenital prosopagnosics will be administered oxytocin and placebo in a double-blind randomized order.
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Intervention will be examined on control group, and on experimental group as well.
Other Names:
Placebo will be given to control group and experimental group as well.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Memory performance
Time Frame: Day 2 (24 hours after encoding)
|
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.
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Day 2 (24 hours after encoding)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mood measurement
Time Frame: Day 1 (after oxytocin/placebo uptake)
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Participants will fill a PANAS mood questionnaire in order to monitor the effects of mood and fatigue of oxytocin/placebo.
We will use ANOVA on the total score of the test in order to verify that differences in performance are not due to change in mood or fatigue after substance uptake.
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Day 1 (after oxytocin/placebo uptake)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shelef Ilan, MD, Soroka University Medical Center
- Principal Investigator: Galia Avidan, Ph.D, Ben-Gurion University of the Negev
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Avidan G, Behrmann M. Implicit familiarity processing in congenital prosopagnosia. J Neuropsychol. 2008 Mar;2(1):141-64. doi: 10.1348/174866407x260180.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
January 26, 2014
First Submitted That Met QC Criteria
March 17, 2014
First Posted (Estimate)
March 19, 2014
Study Record Updates
Last Update Posted (Estimate)
July 2, 2015
Last Update Submitted That Met QC Criteria
July 1, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sor010712ctil
- ISF, 384/10 (Other Grant/Funding Number: israeli Science Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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