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

University of Electronic Science and Technology of China

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: Placebo nasal spray; Drug: Oxytocin nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT03085654

UESTC-neuSCAN_10

Details and patient eligibility

About

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

Full 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.

Enrollment: 147 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• healthy adult males

Exclusion:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 6 patient groups

High anxiety group (single dose)

Experimental group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo nasal spray

High anxiety group (3 doses)

Experimental group

Description:

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.

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo nasal spray

High anxiety group (5 doses)

Experimental group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo nasal spray

Low anxiety group (single dose)

Experimental group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo nasal spray

Low anxiety group (3 doses)

Experimental group

Description:

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.

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo nasal spray

Low anxiety group (5 doses)

Experimental group

Description:

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

Treatment:

Drug: Oxytocin nasal spray

Drug: Placebo nasal spray