Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses

NCT ID: NCT03610919

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2018-12-01

Brief Summary

The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored.

Detailed Description

In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.

Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Oxytocin nasal spray(5 doses)

Oxytocin nasal spray for 5 days, 24 IU per day

Group Type: EXPERIMENTAL

Nasal Sprays

Intervention Type: DRUG

Intranasal administration of 24 international units per dose.

Oxytocin nasal spray(3 doses)

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

Group Type: EXPERIMENTAL

Nasal Sprays

Intervention Type: DRUG

Intranasal administration of 24 international units per dose.

Placebo nasal spray(control group)

Placebo nasal spray for 5 days,24 IU per day.

Group Type: PLACEBO_COMPARATOR

Nasal Sprays

Intervention Type: DRUG

Intranasal administration of 24 international units per dose.

Interventions

Nasal Sprays

Intranasal administration of 24 international units per dose.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• healthy adult males

Exclusion Criteria

• past or current psychiatric or neurological disorder head trauma substance abuse medication fMRI contraindications (e.g. metal implants)

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Electronic Science and Technology of China

OTHER

Sponsor Role: lead

Responsible Party

Keith Kendrick

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith Kendrick, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

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

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Benjamin Becker, PhD

Role: CONTACT

ben_becker@gmx.de

+86 2861 830 811

Weihua Zhao, PhD

Role: CONTACT

zarazhao.uestc@outlook.com

+86 2861 830 811

Facility Contacts

Weihua Zhao, PhD

Role: primary

Other Identifiers

UESTC-neuSCAN-57

Identifier Type: -

Identifier Source: org_study_id