HealthyEarly Phase 1NCT02091817
The Effect of Oxytocin on Face Perception
A Early Phase 1 study testing Oxytocin in people with Healthy and Congenital Prosopagnosia, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether oxytocin affect face perception Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Congenital Prosopagnosia
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal or corrected to normal vision
Who cannot join
- 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
Show all 10Show fewer
- liver cirrhosis
- neurological disease
- other chronic disease
- dementia, or lack of judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Healthy, Congenital Prosopagnosia
- Being tested
- Oxytocin, Placebo
- Keywords
- oxytocin, face, memory
- Medical subject headings
- Prosopagnosia, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
Intervention will be examined on control group, and on experimental group as well.
PlaceboDrug
Placebo will be given to control group and experimental group as well.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Control group will be administered oxytocin and placebo, in a double-blind randomized order. Receives: Drug: Oxytocin; Drug: Placebo |
| congenital prosopagnosia | Experimental | Congenital prosopagnosics will be administered oxytocin and placebo in a double-blind randomized order. Receives: Drug: Oxytocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 2 (24 hours after encoding)
Secondary outcomes (1)
Mood measurement
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.
Measured: Day 1 (after oxytocin/placebo uptake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: We are currently engaged in other behavioral study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Ilan Shelef, Soroka University Medical Center
- Investigators
- Shelef Ilan, MD, Principal investigator, Soroka University Medical CenterGalia Avidan, Ph.D, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091817
- Sponsor's protocol ID
- sor010712ctil
- Other IDs
- ISF, 384/10
- Status last verified
- Jul 2015
- First submitted
- 26 Jan 2014
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19481456Avidan G, Behrmann M. Implicit familiarity processing in congenital prosopagnosia. J Neuropsychol. 2008 Mar;2(1):141-64. doi: 10.1348/174866407x260180.
PubMed 19334309Avidan 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.
PubMed 16102242Behrmann 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.
PubMed 16102241Hasson 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.
PubMed 12729493MacDonald 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.
PubMed 21429671Avidan 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.
PubMed 23377287
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Behavioral and Neural Effects of Oxytocin on Face Perception in Congenital Prosopagnosia
- ClinicalTrials.gov ID
- NCT02091817
- Acronym / sponsor ID
- sor010712ctil
- Conditions
- Healthy, Congenital Prosopagnosia
- Keywords
- oxytocin, face, memory
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: We are currently engaged in other behavioral study.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether oxytocin affect face perception
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: Oxytocin, Drug: PlaceboControl group will be administered oxytocin and placebo, in a double-blind randomized order. |
| congenital prosopagnosia | Experimental | Drug: Oxytocin, Drug: PlaceboCongenital prosopagnosics will be administered oxytocin and placebo in a double-blind randomized order. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- normal or corrected to normal vision
Key exclusion criteria (10 listed)
- minors
- pregnancy (according to a pregnancy test taken by subjects prior to participation)
- a history of asthma or nasal polyps
- cardiac disorders
- hyponatremia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: syntocinonIntervention will be examined on control group, and on experimental group as well. | Drug | Control group, congenital prosopagnosia |
| PlaceboPlacebo will be given to control group and experimental group as well. | Drug | Control group, congenital prosopagnosia |
Primary outcome
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.
1 secondary outcome
Mood measurement
Time frame: Day 1 (after oxytocin/placebo uptake)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Background: PubMed 19481456Avidan 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.
- Background: PubMed 19334309Avidan G, Behrmann M. Implicit familiarity processing in congenital prosopagnosia. J Neuropsychol. 2008 Mar;2(1):141-64. doi: 10.1348/174866407x260180.
- Background: PubMed 16102242Avidan 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.
- Background: PubMed 16102241Behrmann 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.
- Background: PubMed 12729493Hasson 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.
- Background: PubMed 21429671MacDonald 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.
- Background: PubMed 23377287Avidan 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.
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelef Ilan, MD principal investigator
Soroka University Medical Center
Galia Avidan, Ph.D principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin in people with Healthy and Congenital Prosopagnosia, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory performance (time frame: Day 2 (24 hours after encoding)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091817, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2015.