The Effects of Oxytocin and Vasopressin on Delta-beta Cross-frequency Coupling

Not Applicable

• Conditions: Healthy
• Interventions: Drug: Intranasal Oxytocin (IN-OXT); Drug: Intranasal Vasopressin (AVP); Drug: Intranasal Placebo

• Registration Number: NCT06605300
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

The main aim of the study is to investigate whether intranasal oxytocin and vasopressin have effects on delta-beta cross-frequency coupling under resting-state and task conditions.

Detailed Description

A double-blinded, placebo-controlled, between-subject design is employed in this study. In a randomized order, a total of 120 healthy males and females are instructed to self-administer intranasal spray of oxytocin, vasopressin, or placebo. (1) 15-minute resting-state EEG data are collected 35 minutes after treatment. (2) Participants complete tasks including Stroop, GO/NOGO, and anxiety induction with behavioral (response time, accuracy, or rating) and EEG data being collected. Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), and Adult ADHD Self-Report Scale (ASRS-v1.1). Participants are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before resting state and after the tasks. Three blood samples (5 ml) are collected into 6 ml ETDA tubes when participants just arrive, before resting state recording and after all of the tasks.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-07-01
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-20
• Last Update Posted: 2024-09-20
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion Criteria

• History of head injury.
• Pregnant,menstruating,taking oral contraceptives.
• Medical or psychiatric illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin	Intranasal Oxytocin (IN-OXT)	A single dose of 24 international units (IU) of OT will be administered with 3 puffs of treatment to each nostril.
vasopressin	Intranasal Vasopressin (AVP)	A single dose of 20 international units (IU) of AVP will be administered with 3 puffs of treatment to each nostril.
placebo	Intranasal Placebo	A single dose of PLC will be administered with 3 puffs of treatment to each nostril.

Primary Outcome Measures

Name	Time	Method
Resting-state EEG	35-50 minutes after treatment administration.	Participants are asked to sit comfortably and look at a white cross fixation against a black background on the computer monitor for 15 minutes with delta-beta cross-frequency coupling as a main index.
Behavioral indices in the tasks	50-90 minutes after treatment administration.	Reaction time and accuracy are recorded in the Stroop and GO/NO GO tasks. For the anxiety induction task, participants are instructed to rate their anxiety levels using a 9-point Likert scale within 4 seconds (1 = not at all, 9 = very anxious).
Task-based EEG	50-90 minutes after treatment administration.	EEG data are recorded in the Stroop, GO/NOGO, and anxiety induction tasks. Delta-beta cross-frequency coupling will be calculated to do statistical analyses.

Secondary Outcome Measures

Name	Time	Method
SCR in anxiety induction	70-90 minutes after treatment administration.	Skin Conductance Response (SCR) data are recorded in the anxiety induction task under safe and anxious conditions.

Trial Locations

Locations (1)

University of Electronic Science and Technology of China (UESTC); 🇨🇳 Chengdu, Sichuan, China