Learning DisabilitiesNCT03846271
Effects of Oxytocin on Reinforcement Learning
A study testing intranasal oxytocin in people with Learning Disabilities, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning. 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
- Learning Disabilities
- What is being tested?
- intranasal oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2018to 31 Jul 2019
- 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
- Age between 18-30
- Male sex
- Right handedness
Who cannot join
- History of brain injury
- Current or history of psychiatric, neurological or internist disorder
- Current or regular use of medication, psychotropic substances, including nicotine
- Contraindications for Oxytocin
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, 611731
About this study
Official title: The Effects of Intranasal Oxytocin on Reward Sensitivity and Performance Monitoring During Reinforcement Learning: an ERP Study
The main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning.
Read the detailed description
A double-blind, within-subject, placebo-controlled pharmacological EEG design will be employed. A total of 35 healthy male subjects will be recruited which will receive either intranasal placebo or oxytocin (24IU) on two separate study days (order counter-balanced, washout period at least 2 weeks). 45 minutes after treatment subjects will undergo a probabilistic feedback reinforcement learning paradigm with concurrent EEG acquisition. During the paradigm subjects will learn the reward probabilities of two different visual stimuli from probabilistic feedback provided by social stimuli (positive, negative emoticon). The paradigm includes an initial acquisition phase and a subsequent test phase.
- Conditions
- Learning Disabilities
- Being tested
- intranasal oxytocin, intranasal placebo
- Keywords
- Oxytocin, performance monitoring, reinforcement learning
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal oxytocinDrug
24 IU of oxytocin nasal spray will be applied to each subject.
intranasal placeboDrug
an identical amount of placebo nasal spray will be applied to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin then placebo | Experimental | Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo. Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
| Placebo then oxytocin | Experimental | Participants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU). Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase
Feedback Related Negativity (FRN): a negative ERP component evoked by negative feedback relative to positive feedback during the acquisition phase will be compared between the oxytocin and placebo treatment conditions.
Measured: 45-105 minutes after treatment administration
Neural index: Event-related potential: Error Related Negativity (ERN) during the test phase
Error Related Negativity (ERN): a negative ERP component evoked by incorrect responses relative to correct responses during the test phase will be compared between the oxytocin and placebo treatment conditions.
Measured: 45-105 minutes after treatment administration
Secondary outcomes (5)
Behavioral index: Response accuracy to superior stimuli during the acquisition phase
Correct responses are defined as choices of the stimulus associated with higher probability positive feedback during the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Measured: 45-105 minutes after treatment administration
Behavioral index: Response accuracy to stimuli associated with highest probability positive feedback during the test phase
Correct responses are defined as choices of the stimulus associated with highest probability positive feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Measured: 45-105 minutes after treatment administration
Response accuracy avoiding stimuli associated with highest probability negative feedback in the test phase.
Correct responses are defined as avoidance choices of stimuli associated with highest probability negative feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Measured: 45-105 minutes after treatment administration
Response accuracy in response to superior stimuli associated with relative higher probability positive feedback in the test phase.
Correct responses are defined as choices of the stimulus associated with higher probability positive feedback. Note that stimuli pairs in this measurement are all associated with positive feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Measured: 45-105 minutes after treatment administration
Response accuracy avoiding stimuli associated with higher probability negative feedback in the test phase.
Correct responses are defined as avoidance choices of stimuli associated with higher probability negative feedback. Note that stimuli pairs in this measurement are all associated with negative feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Measured: 45-105 minutes after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start4 Dec 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisabilitiesStudies 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
- Model description
- Randomized placebo-controlled double-blind within-subject design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Keith Kendrick, PhD, Principal investigator, University of Electronic Science and Technology of China(UESTC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846271
- Sponsor's protocol ID
- UESTC-neuSCAN-61
- Status last verified
- Feb 2019
- First submitted
- 25 Jan 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intranasal Oxytocin on Reward Sensitivity and Performance Monitoring During Reinforcement Learning: an ERP Study
- ClinicalTrials.gov ID
- NCT03846271
- Acronym / sponsor ID
- UESTC-neuSCAN-61
- Conditions
- Learning Disabilities
- Keywords
- Oxytocin, performance monitoring, reinforcement learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 19 Feb 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 main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning.
Detailed description
A double-blind, within-subject, placebo-controlled pharmacological EEG design will be employed. A total of 35 healthy male subjects will be recruited which will receive either intranasal placebo or oxytocin (24IU) on two separate study days (order counter-balanced, washout period at least 2 weeks). 45 minutes after treatment subjects will undergo a probabilistic feedback reinforcement learning paradigm with concurrent EEG acquisition. During the paradigm subjects will learn the reward probabilities of two different visual stimuli from probabilistic feedback provided by social stimuli (positive, negative emoticon). The paradigm includes an initial acquisition phase and a subsequent test phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled double-blind within-subject design
| Arm | Type | Receives |
|---|---|---|
| Oxytocin then placebo | Experimental | Drug: intranasal oxytocin, Drug: intranasal placeboParticipants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo. |
| Placebo then oxytocin | Experimental | Drug: intranasal oxytocin, Drug: intranasal placeboParticipants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-30
- Male sex
- Right handedness
Key exclusion criteria (4 listed)
- History of brain injury
- Current or history of psychiatric, neurological or internist disorder
- Current or regular use of medication, psychotropic substances, including nicotine
- Contraindications for Oxytocin
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 oxytocin24 IU of oxytocin nasal spray will be applied to each subject. | Drug | Oxytocin then placebo, Placebo then oxytocin |
| intranasal placeboan identical amount of placebo nasal spray will be applied to each subject. | Drug | Oxytocin then placebo, Placebo then oxytocin |
Primary outcome
Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase
Time frame: 45-105 minutes after treatment administration
Feedback Related Negativity (FRN): a negative ERP component evoked by negative feedback relative to positive feedback during the acquisition phase will be compared between the oxytocin and placebo treatment conditions.
Neural index: Event-related potential: Error Related Negativity (ERN) during the test phase
Time frame: 45-105 minutes after treatment administration
Error Related Negativity (ERN): a negative ERP component evoked by incorrect responses relative to correct responses during the test phase will be compared between the oxytocin and placebo treatment conditions.
5 secondary outcomes
Behavioral index: Response accuracy to superior stimuli during the acquisition phase
Time frame: 45-105 minutes after treatment administration
Behavioral index: Response accuracy to stimuli associated with highest probability positive feedback during the test phase
Time frame: 45-105 minutes after treatment administration
Response accuracy avoiding stimuli associated with highest probability negative feedback in the test phase.
Time frame: 45-105 minutes after treatment administration
Response accuracy in response to superior stimuli associated with relative higher probability positive feedback in the test phase.
Time frame: 45-105 minutes after treatment administration
Response accuracy avoiding stimuli associated with higher probability negative feedback in the test phase.
Time frame: 45-105 minutes after treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 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.
Keith Kendrick, PhD principal investigator
University of Electronic Science and Technology of China(UESTC)
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 in people with Learning Disabilities, 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 4 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: status not confirmed, as of the sponsor's last update on 19 Feb 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuang Qian, MD (13086663679, zq19910362@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase (time frame: 45-105 minutes after treatment administration). The study lists 2 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 19 Feb 2019.