NCT03891459

Brief Summary

The current study aimed to reveal the neural mechanism of social placebo belief formation and belief representation, and also investigated how the brain pattern predict the social behavior performance under placebo manipulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

March 17, 2019

Last Update Submit

March 24, 2019

Conditions

Keywords

social placebo effectfMRIneural account

Outcome Measures

Primary Outcomes (3)

  • The brain functional connectivity

    For functional connectivity estimation, we adopted DLPFC, mPFC and reward related brain regions as the seeds to do whole-brain connectivity analysis. And the conducted two-sample T test to examine whether there would be some differences between spray+ and control groups.

    8 mins, 240 TR in scanner

  • Social brain network properties in resting-state

    For the network properties, we chose the social brain network as our target and interested network, then estimated the global efficiency within this network.And the conducted two-sample T test to examine whether there would be some differences between spray+ and control groups.

    8 mins, 240 TR in scanner

  • The brain response pattern for the key concepts about oxytocin

    We estimated the beta response trial by trial for each single concept and then investigated the neural representation of all concepts by using representational similarity analysis (RSA).

    5.33mins, 160TR in scanner

Study Arms (2)

spray+ group

EXPERIMENTAL

In spray+ condition, participants learned oxytocin materials on a self-paced basis and then intranasally administered with saline (but it was told as "oxytocin"). Participants were instructed to refrain from smoking or drinking (except water) for 2 h before the experiment. The spray was administered to each participant three times, and each administration consisted of one inhalation into each nostril. Participants took a rest (they were told it was a time period waiting for treatment to produce effects) for 10min and then performed the experimental tasks.

Behavioral: spray+ manipulation

control group

PLACEBO COMPARATOR

In control condition, the materials and procedure were same with the spray+ condition except the nasal spray was told as "saline" instead. Oxytocin materials used in current experiments were adopted from previous study

Behavioral: control manipulation

Interventions

Participants in spray+ group received placebo manipulation and were told they sprayed was oxytocin (in fact, it was saline);

spray+ group

Participants in control group were told they sprayed saline (in fact, it was saline).

control group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All participants had normal or corrected-to-normal vision, and mental healthy.

You may not qualify if:

  • Participants who reported no history of neurological, endocrine or psychiatric disorders, who majored in psychology in college or recently participated in any other drug study were not recruited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Normal University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Behavior Control

Intervention Hierarchy (Ancestors)

TherapeuticsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 27, 2019

Study Start

June 27, 2018

Primary Completion

November 2, 2018

Study Completion

November 5, 2018

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations