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

NCT ID: NCT03085654

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2018-04-30

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.

Detailed Description

In the present study, healthy male subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory (STAI). According to subjects' trait anxiety scores, they will be divided into high or low anxiety experimental groups.

Next, experiments will investigate the acute effect (single dose) and chronic effect (3 doses or 5 doses) of oxytocin on brain functional connectivity during resting-state and brain activation in response to watching emotional stimuli using functional magnetic resonance imaging (fMRI). Also the brain structure data (T1 and diffusion tensor imaging, DTI) of subjects will be collected. After finishing the scanning tasks, subjects will be required to rate the emotional valence, intensity and arousal of the pictures shown in the scanner.

During the course of the study subjects will complete a number of questionnaires: Empathy Quotient (EQ), Cheek and Buss Shyness scale (CBSS),Interpersonal Reactivity Index (IRI),Childhood Trauma Questionnaire (CTQ),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS),Positive and Negative Affect Schedule (PANAS),d2 attention test, and the Visual Analogue Scale for anxiety.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

High anxiety group (single dose)

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Intranasal administration of oxytocin 24 international units per dose.

Placebo nasal spray

Intervention Type: DRUG

Intranasal administration of placebo 24 international units per dose.

High anxiety group (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 in subjects with high trait anxiety.

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Intranasal administration of oxytocin 24 international units per dose.

Placebo nasal spray

Intervention Type: DRUG

Intranasal administration of placebo 24 international units per dose.

High anxiety group (5 doses)

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Intranasal administration of oxytocin 24 international units per dose.

Placebo nasal spray

Intervention Type: DRUG

Intranasal administration of placebo 24 international units per dose.

Low anxiety group (single dose)

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Intranasal administration of oxytocin 24 international units per dose.

Placebo nasal spray

Intervention Type: DRUG

Intranasal administration of placebo 24 international units per dose.

Low anxiety group (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 in subjects with low trait anxiety.

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Intranasal administration of oxytocin 24 international units per dose.

Placebo nasal spray

Intervention Type: DRUG

Intranasal administration of placebo 24 international units per dose.

Low anxiety group (5 doses)

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

Intranasal administration of oxytocin 24 international units per dose.

Placebo nasal spray

Intervention Type: DRUG

Intranasal administration of placebo 24 international units per dose.

Interventions

Oxytocin nasal spray

Intranasal administration of oxytocin 24 international units per dose.

Intervention Type: DRUG

Placebo nasal spray

Intranasal administration of placebo 24 international units per dose.

Intervention Type: DRUG

Other Intervention Names

Oxytocin treatment; Placebo control

Eligibility Criteria

Inclusion Criteria

• healthy adult males

Exclusion:

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

• Minimum Eligible Age: 18 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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35086102 (View on PubMed)

Other Identifiers

UESTC-neuSCAN_10

Identifier Type: -

Identifier Source: org_study_id