HealthyNCT05896553
Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction
A study testing intranasal Oxytocin(24IU) in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- intranasal Oxytocin(24IU)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2023to 15 Apr 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
- Normal or corrected-normal version
Who cannot join
- History of head injury
- Medical or psychiatric illness
- Hypertension
- General cardio-vascular alteration or diseases
- Allergy against medications
- Visual or motor impairments
Show all 10Show fewer
- Claustrophobia
- Drug addiction
- Nicotine dependence
- FMRI contradictions
Trial locations and contacts
1 site in 1 country.
China1 site
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.
Read the detailed description
In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to either receive intranasal Oxytocin (24IU, n= 30) or intranasal placebo (nasal spray administration without oxytocin, n = 30). Following treatment administration subjects will undergo a resting state functional magnetic resonance imaging (fMRI) assessment (8min) and next watch a long fear-inducing (horror) movie (10min) followed by a resting state fMRI assessment (8min). Effects of treatment on subjective experience will be assessed using 1-9 Likert scales assessing subjective fear, emotional arousal and escape. Ratings will be acquired before the start of the experiment, after the movie and at the end of the experiment. Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.
- Conditions
- Healthy
- Being tested
- intranasal Oxytocin(24IU), intranasal Placebo
- Keywords
- Oxytoxin, Fear, fMRI, Functional Connectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal Oxytocin(24IU)Drug
Administration of intranasal Oxytocin(24IU)
intranasal PlaceboDrug
Administration of intranasal Placebo
| Study group | Role | What they receive |
|---|---|---|
| Oxytoxin group | Experimental | Drug: intranasal Oxytocin(24IU) Receives: Drug: intranasal Oxytocin(24IU) |
| Placebo group | Placebo comparator | Drug: intranasal Placebo Receives: Drug: intranasal Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity during the resting state between brain systems involved in emotional processing.
1.During the 8min resting state before and after the movie clips the intrinsic connectivity of the brain will be assessed. The intrinsic connectivity will be computed as temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. Effects of Oxytocin on the intrinsic architecture of the brain will be examined by comparing the Oxytocin- and Placebo- treated groups.
Measured: Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment
Secondary outcomes (1)
Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip).
Effects of treatment on dynamic functional connectivity during the fear clip watching phase will be examined by comparing dynamic functional connectivity indices between the Oxytoxin- and Placebo-treated group.
Measured: 80 minutes to 90 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start29 May 2023
- Primary completion1 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- Randomized placebo-controlled double-blind between-subject design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
- Investigators
- Benjamin Becker, Dr., Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896553
- Sponsor's protocol ID
- UESTC-BAM-08
- Status last verified
- Apr 2025
- First submitted
- 29 May 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction
- ClinicalTrials.gov ID
- NCT05896553
- Acronym / sponsor ID
- UESTC-BAM-08
- Conditions
- Healthy
- Keywords
- Oxytoxin, Fear, fMRI, Functional Connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 9 Jun 2023 (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 main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.
Detailed description
In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to either receive intranasal Oxytocin (24IU, n= 30) or intranasal placebo (nasal spray administration without oxytocin, n = 30). Following treatment administration subjects will undergo a resting state functional magnetic resonance imaging (fMRI) assessment (8min) and next watch a long fear-inducing (horror) movie (10min) followed by a resting state fMRI assessment (8min). Effects of treatment on subjective experience will be assessed using 1-9 Likert scales assessing subjective fear, emotional arousal and escape. Ratings will be acquired before the start of the experiment, after the movie and at the end of the experiment. Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled double-blind between-subject design
| Arm | Type | Receives |
|---|---|---|
| Oxytoxin group | Experimental | Drug: intranasal Oxytocin(24IU)Drug: intranasal Oxytocin(24IU) |
| Placebo group | Placebo comparator | Drug: intranasal PlaceboDrug: intranasal Placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
- Normal or corrected-normal version
Key exclusion criteria (10 listed)
- History of head injury
- Medical or psychiatric illness
- Hypertension
- General cardio-vascular alteration or diseases
- Allergy against medications
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 |
|---|---|---|
| intranasal Oxytocin(24IU)Administration of intranasal Oxytocin(24IU) | Drug | Oxytoxin group |
| intranasal PlaceboAdministration of intranasal Placebo | Drug | Placebo group |
Primary outcome
Functional connectivity during the resting state between brain systems involved in emotional processing.
Time frame: Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment
1.During the 8min resting state before and after the movie clips the intrinsic connectivity of the brain will be assessed. The intrinsic connectivity will be computed as temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. Effects of Oxytocin on the intrinsic architecture of the brain will be examined by comparing the Oxytocin- and Placebo- treated groups.
1 secondary outcome
Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip).
Time frame: 80 minutes to 90 minutes after treatment
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 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Benjamin Becker, Dr. principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intranasal Oxytocin(24IU) in people with Healthy, run by University of Electronic Science and Technology of China 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 3 inclusion and 10 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 4 Apr 2025. 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?
Functional connectivity during the resting state between brain systems involved in emotional processing. (time frame: Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment). 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 4 Apr 2025.