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Effect of Oral Oxytocin on Women's Response to Emotional Stimuli

NCT ID: NCT05073939

Last Updated: 2021-10-21

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

2021-04-01

Study Completion Date

2022-01-30

Brief Summary

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The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate females' neural and behavioral responses to affective stimuli including emotional faces and affective scenes.

Detailed Description

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All subjects will complete a series of questionnaires firstly 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), Positive and Negative Affect Schedule (PANAS). PANAS is administered before and after oral administration and after functional magnetic resonance imaging (fMRI) scanning. In the current double-blind, between-subject, placebo-controlled study 80 healthy female subjects will be recruited and receive oral administration either oxytocin (24IU) or placebo. Blood samples are collected twice before and 30 minutes after oral administration to assess the plasma OXT concentrations change. 45 minutes after oral administration subjects will be required to finish fMRI scanning including resting-state fMRI task, emotional face task (happy, fear, angry and neutral faces), affective scene task (NAPS, Nencki affective picture system, positive, neutral, and negative-valence scenes). After fMRI scanning, subjects will be required to rate valence, intensity, and arousal responses (Likert scale, 1-9 ratings) to the emotional and affective stimuli are presented during fMRI scanning.

Conditions

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Healthy

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

Other Intervention Names

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Oxytocin Orally Placebo Orally

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

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

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 M 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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Keith M Kendrick, PhD

Role: CONTACT

[email protected]
86-28-61830811

Weihua Zhao, PhD

Role: CONTACT

[email protected]
86-28-61830811

Facility Contacts

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Weihua Zhao, PhD

Role: primary

Other Identifiers

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UESTC-neuSCAN-84

Identifier Type: -

Identifier Source: org_study_id