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Oral Oxytocin Modulation of Responses to Emotional Stimuli

NCT ID: NCT04320706

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-20

Study Completion Date

2021-03-01

Brief Summary

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The main aim of the study is to investigate whether orally administered oxytocin (24IU) can modulate neural and behavioral responses to positive and negative valence stimuli during basal (emotional scenes) and higher order (facial stimuli) emotional processing.

Detailed Description

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A number of previous studies have reported both neural and social cognition effects of intranasally administered oxytocin, although it is unclear whether functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations. The investigators hypothesize that one method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually. In the current double-blind, between-subject, placebo controlled study 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment subjects will be required to complete both face emotion and emotional scene processing tasks during fMRI scanning. After the tasks, subjects will be required to rate their valence, intensity and arousal response to the same emotional face and scene stimuli which were presented during MRI acquisition. Blood samples will be taken before and 30 min after the oral treatment interventions to assess oxytocin blood concentrations. All subjects will be asked to complete a range of questionnaires before treatment to control for possible pre-treatment confounders in terms of personality traits and mood: Beck Depression Inventory II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), the Second Version of Social Responsiveness Scale(SRS-2), and Interpersonal Reactivity Index (IRI).

Conditions

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Healthy

Keywords

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oral Oxytocin emotional processing anxiety reward

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo-controlled double-blind between-subject design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oral Oxytocin

Oxytocin orally (24 IU)

Group Type EXPERIMENTAL

Oral Oxytocin

Intervention Type DRUG

Administration of oxytocin (24 international units) orally

Oral Placebo

Placebo orally (identical ingredients, except the active agent)

Group Type PLACEBO_COMPARATOR

Oral Placebo

Intervention Type DRUG

Administration of placebo orally

Interventions

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Oral Oxytocin

Administration of oxytocin (24 international units) orally

Intervention Type DRUG

Oral Placebo

Administration of placebo orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria

* History of brain injury
* Head trauma
* Substance abuse
* Medication
* fMRI contraindications (e.g. metal implants)
Minimum Eligible Age

17 Years

Maximum Eligible Age

32 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Keith Kendrick

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith Kendrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

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school of life science and technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Benjamin Becker, PhD

Role: CONTACT

Phone: +86 2861 830 811

Email: [email protected]

Weihua Zhao, PhD

Role: CONTACT

Phone: 86 2861 830 811

Email: [email protected]

Facility Contacts

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Weihua Zhao, PhD

Role: primary

Other Identifiers

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UESTC-neuSCAN-60

Identifier Type: -

Identifier Source: org_study_id