Oral Oxytocin Modulation of Responses to Emotional Stimuli

NCT04320706 | Unknown

• 1 other identifier: UESTC-neuSCAN-60
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

oral Oxytocin; emotional processing; anxiety; reward

Outcome Measures

Primary Outcomes (4)

• Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI

  Comparison of neural activation as assessed by functional MRI on the whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (happy, neutral, angry, fear) ANOVAs and emotion-specific comparisons between the treatment groups. We hypothesized that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.

  45-90 minutes after treatment

• Effect of oral oxytocin administration on neural responses to positive and negative valence scenes, as assessed by fMRI

  Comparison of neural activation as assessed by functional MRI on whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (neutral, positive, negative) ANOVAs and emotion-specific post hoc comparisons between the treatment groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.

  45-90 minutes after treatment

• Effect of oral oxytocin administration on behavioral ratings of face emotion and scene stimuli

  Comparison of behavioral ratings of valence, arousal and intensity (9-point Likert scale) for emotional face and social scene stimuli presented again post-scan will be performed in oxytocin versus placebo control groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on behavioral ratings of positive and negative valence emotional stimuli. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively in a different pattern of functional effects.

  45-115 minutes after treatment

• Change in blood oxytocin concentrations following oral administration of oxytocin

  Changes in blood concentrations of oxytocin from baseline after oral oxytocin treatment will be assessed by comparison with the placebo group. We hypothesize that oral oxytocin should produce a significant increase in blood oxytocin concentrations after 30 minutes.

  30 minutes before treatment and 30 minutes after treatment

Secondary Outcomes (3)

• Correlations between neural responses/functional connectivity changes and post-scan behavioral ratings

  45-115 minutes after treatment

• Correlations between neural responses/functional connectivity in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin

  30 minutes before treatment to 90 minutes after treatment

• Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations

  30 minutes before treatment to 115 minutes after treatment

Study Arms (2)

Oral Oxytocin

EXPERIMENTAL

Oxytocin orally (24 IU)

Drug: Oral Oxytocin

Oral Placebo

PLACEBO COMPARATOR

Placebo orally (identical ingredients, except the active agent)

Drug: Oral Placebo

Interventions

Oral Oxytocin DRUG

Administration of oxytocin (24 international units) orally

Oral Oxytocin

Oral Placebo DRUG

Administration of placebo orally

Oral Placebo

Eligibility Criteria

• Age: 17 Years - 32 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of brain injury
• Head trauma
• Substance abuse
• Medication
• fMRI contraindications (e.g. metal implants)

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

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

Chengdu, Sichuan, 610054, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Keith Kendrick, PhD

  University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Becker, PhD

CONTACT

+86 2861 830 811; ben_becker@gmx.de

Weihua Zhao, PhD

CONTACT

86 2861 830 811; zarazhao.uestc@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized placebo-controlled double-blind between-subject design

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 25, 2020
• Study Start: February 20, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

CN (1)