Spray+ GroupNCT03891459
Neural Account of Social Placebo Effect
A study testing spray+ manipulation in people with Spray+ Group and Control Group, run by Beijing Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spray+ Group, Control Group
- What is being tested?
- spray+ manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2018to 5 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants had normal or corrected-to-normal vision, and mental healthy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spray+ Group, Control Group
- Being tested
- spray+ manipulation, control manipulation
- Keywords
- social placebo effect, fMRI, neural account
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spray+ manipulationBehavioural
Participants in spray+ group received placebo manipulation and were told they sprayed was oxytocin (in fact, it was saline);
control manipulationBehavioural
Participants in control group were told they sprayed saline (in fact, it was saline).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: control manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 5.33mins, 160TR in scanner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start27 Jun 2018
- Primary completion2 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spray+ GroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ma, yina, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891459
- Sponsor's protocol ID
- FSPE
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Account of Social Placebo Effect
- ClinicalTrials.gov ID
- NCT03891459
- Acronym / sponsor ID
- FSPE
- Conditions
- Spray+ Group, Control Group
- Keywords
- social placebo effect, fMRI, neural account
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spray+ group | Experimental | Behavioral: spray+ manipulationIn 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. |
| control group | Placebo comparator | Behavioral: control manipulationIn 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants had normal or corrected-to-normal vision, and mental healthy.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spray+ manipulationParticipants in spray+ group received placebo manipulation and were told they sprayed was oxytocin (in fact, it was saline); | Behavioural | spray+ group |
| control manipulationParticipants in control group were told they sprayed saline (in fact, it was saline). | Behavioural | control group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spray+ manipulation in people with Spray+ Group and Control Group, run by Beijing Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The brain functional connectivity (time frame: 8 mins, 240 TR in scanner). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.