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Trial record 8 of 34149 for:    Placebo AND placebo effect

Neural Account of Social Placebo Effect

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ClinicalTrials.gov Identifier: NCT03891459
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
ma, yina, Beijing Normal University

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.

Condition or disease Intervention/treatment Phase
Spray+ Group Control Group Behavioral: spray+ manipulation Behavioral: control manipulation Not Applicable

Detailed Description:

Participants were randomly assigned to spray+ group (sprayed with saline but told as "oxytocin") and control group (sprayed with saline but told as "saline"). After 10 min, participants were invited to the resting-state, text viewing task in fMRI scanner.

In resting state session, participants with their eyes open and were instructed to attend to a black fixation cross centrally presented on a grey projection screen for 8 min (240TR).

The Text viewing task employed a mixed block and even-related fMRI design. Participants were asked to judge whether they could understand the stimuli or not by a button press (1=understand; 2=not understand). Three kinds of stimuli were presented in separate block including "oxytocin-function", "oxytocin-knowledge", "robot" related stimuli, each category contained 20 sentences. In each block, the sentence (within one category) was presented pseudo-randomized from 5s to 9s (with mean duration of 7s), then followed by a jittered time interval (interval time = sentence duration - response time; if participants made response within 5s, the sentence would not disappear until its duration reached 5s). There were two sessions with six blocks per session, and there were 5 sentences (trials) per block. The order of blocks and sentences were designed to present in pseudo-random order and were applied to all participants.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neural Account of Social Placebo Effect
Actual Study Start Date : June 27, 2018
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : November 5, 2018

Arm Intervention/treatment
Experimental: spray+ group
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
Participants in spray+ group received placebo manipulation and were told they sprayed was oxytocin (in fact, it was saline);

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




Primary Outcome Measures :
  1. The brain functional connectivity [ Time Frame: 8 mins, 240 TR in scanner ]
    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.

  2. Social brain network properties in resting-state [ Time Frame: 8 mins, 240 TR in scanner ]
    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.

  3. The brain response pattern for the key concepts about oxytocin [ Time Frame: 5.33mins, 160TR in scanner ]
    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).



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891459


Locations
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China, Beijing
Beijing Normal University
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Beijing Normal University

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Responsible Party: ma, yina, Principal Investigator, Beijing Normal University
ClinicalTrials.gov Identifier: NCT03891459     History of Changes
Other Study ID Numbers: FSPE
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ma, yina, Beijing Normal University:
social placebo effect
fMRI
neural account

Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs