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Trial record 8 of 34206 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

Tracking Information
First Submitted Date  ICMJE March 17, 2019
First Posted Date  ICMJE March 27, 2019
Last Update Posted Date March 27, 2019
Actual Study Start Date  ICMJE June 27, 2018
Actual Primary Completion Date November 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2019)
  • 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.
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Account of Social Placebo Effect
Official Title  ICMJE Neural Account of Social Placebo Effect
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Spray+ Group
  • Control Group
Intervention  ICMJE
  • Behavioral: spray+ manipulation
    Participants in spray+ group received placebo manipulation and were told they sprayed was oxytocin (in fact, it was saline);
  • Behavioral: control manipulation
    Participants in control group were told they sprayed saline (in fact, it was saline).
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: spray+ manipulation
  • 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
    Intervention: Behavioral: control manipulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2019)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 5, 2018
Actual Primary Completion Date November 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891459
Other Study ID Numbers  ICMJE FSPE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ma, yina, Beijing Normal University
Study Sponsor  ICMJE Beijing Normal University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Normal University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP