Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety

NCT03085654 | Completed Early Phase 1

• 1 other identifier: UESTC-neuSCAN_10
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.

Conditions

Healthy

Keywords

multiple doses; oxytocin; trait anxiety

Outcome Measures

Primary Outcomes (2)

• Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI

  Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days

  5 days

• Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI

  Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days

  5 days

Secondary Outcomes (6)

• Interaction of acute and chronic treatment effects with trait anxiety on neural activity

  5 days

• Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity

  5 days

• Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment)

  5 days

• Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment)

  5 days

• Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment)

  5 days

Study Arms (6)

High anxiety group (single dose)

EXPERIMENTAL

Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety.

Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

High anxiety group (3 doses)

EXPERIMENTAL

Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with high trait anxiety.

Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

High anxiety group (5 doses)

EXPERIMENTAL

Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety.

Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

Low anxiety group (single dose)

EXPERIMENTAL

Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety.

Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

Low anxiety group (3 doses)

EXPERIMENTAL

Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with low trait anxiety.

Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

Low anxiety group (5 doses)

EXPERIMENTAL

Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety.

Drug: Oxytocin nasal spray; Drug: Placebo nasal spray

Interventions

Oxytocin nasal spray DRUG

Intranasal administration of oxytocin 24 international units per dose.

Also known as: Oxytocin treatment

High anxiety group (3 doses); High anxiety group (5 doses); High anxiety group (single dose); Low anxiety group (3 doses); Low anxiety group (5 doses); Low anxiety group (single dose)

Placebo nasal spray DRUG

Intranasal administration of placebo 24 international units per dose.

Also known as: Placebo control

High anxiety group (3 doses); High anxiety group (5 doses); High anxiety group (single dose); Low anxiety group (3 doses); Low anxiety group (5 doses); Low anxiety group (single dose)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adult males

You may not qualify if:

• past or current psychiatric or neurological disorder
• 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

Location

Related Publications (1)

• Kou J, Zhang Y, Zhou F, Gao Z, Yao S, Zhao W, Li H, Lei Y, Gao S, Kendrick KM, Becker B. Anxiolytic Effects of Chronic Intranasal Oxytocin on Neural Responses to Threat Are Dose-Frequency Dependent. Psychother Psychosom. 2022;91(4):253-264. doi: 10.1159/000521348. Epub 2022 Jan 27.

  PMID: 35086102 DERIVED

Study Officials

• Keith Kendrick, PhD

  University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: March 21, 2017
• Study Start: March 3, 2017
• Primary Completion: March 31, 2018
• Study Completion: April 30, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)