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

U

University of Electronic Science and Technology of China

Status

Unknown

Conditions

Healthy

Treatments

Drug: Oral Oxytocin
Drug: Oral Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05073939
UESTC-neuSCAN-84

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

Oral Oxytocin
Experimental group
Description:
Oxytocin orally (24 IU)
Treatment:
Drug: Oral Oxytocin
Oral Placebo
Placebo Comparator group
Description:
Placebo orally (identical ingredients, except the active agent)
Treatment:
Drug: Oral Placebo

Trial contacts and locations

1

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Central trial contact

Weihua Zhao, PhD; Keith M Kendrick, PhD

Data sourced from clinicaltrials.gov

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