Oxytocin GroupNCT03891095
Oxytocin and Dopamine's Effect on Vicarious Optimism
A study testing Oxytocin and L-DOPA in people with Oxytocin Group and L-DOPA Group, run by Beijing Normal University at 1 site in China.
Trial summary
To investigate the effect of intranasal Oxytocin and L-DOPA's effect on vicarious optimism. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxytocin Group, L-DOPA Group, Placebo Group
- What is being tested?
- Oxytocin and L-DOPA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 16 Jan 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy subjects without past or current psychiatric or neurological disorders
Who cannot join
- subjects with past or current psychiatric or neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of intranasal Oxytocin and L-DOPA's effect on vicarious optimism.
Read the detailed description
The current study adopted a double-blind, double-dummy, placebo-controlled mixed design, with Treatment (oxytocin, dopamine, and placebo) as a between-subjects factor, and Target (self, friend, and an identifiable stranger) and Feedback (desirable vs. undesirable) as within-subjects factors. Upon arrival, participants first completed a set of questionnaires, including mood measurements and other questionnaires related to optimistic or prosocial tendency. Participants then self-administered with the pharmacological challenge 40 min before the main task, i.e., the belief updating task where participants indicated and updated their beliefs about the future of oneself, a gender-matched best friend, and a gender-matched identifiable stranger. At the end, participants completed the mood measurement again, as well the debriefing questionnaires which designed to measure their beliefs about the experimental process.
For the vicarious optimism task, participants completed three blocks of the two-session belief updating task where they were asked to estimate the likelihood of adverse life events happening to three targets: themselves (referred as Self), a gender-matched best friend (referred as Friend), and an identifiable stranger (whose name, brief description and picture were presented to the participants to get familiar with before the estimation, such as "The stranger is Zhexing, a 25-year-old male, Chinese"; referred as Stranger).
Participants completed two estimation sessions for one target before beginning with the next target, and the order of targets was counterbalanced across participants within each group. For the first session of each target block, participants were first presented with 30 different adverse life events (in a random order) and estimated the likelihood of each event happening to the target in the future (the 1st estimation, referred to as E1) on a self-paced basis. Participants were then presented with the probability of each event occurring to an average person in a similar environment (Feedback) for 2s. In the second session, participants estimated the likelihood of the same 30 events (in a random order) happening to the target person again without receiving feedback (the 2nd estimation, referred to as E2).
- Conditions
- Oxytocin Group, L-DOPA Group, Placebo Group
- Being tested
- Oxytocin, L-DOPA, Placebos
- Keywords
- intranasal oxytocin, L-DOPA, Vicarious optimism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
intranasally administrated
L-DOPADrug
orally administered
PlacebosDrug
intranasally administrated and orally administered
| Study group | Role | What they receive |
|---|---|---|
| Intranasal oxytocin | Experimental | Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (24 IU or 40.32 mg; Syntocinon-spray; Novartis, Switzerland) Receives: Drug: Oxytocin; Drug: Placebos |
| L-DOPA | Experimental | L-DOPA, a neuropeptide who is a key modulator of complex socioaffective responses including reward, social decision making, learning. Subjects receiving 187.5 mg Madopar (L-DOPA treatment, including 150 mg L-3,4-dihydroxyphenylalanine, together with 37.5 mg benserazide, which promotes higher levels of dopamine in the brain while minimizing side effects from peripheral dopamine) Receives: Drug: L-DOPA; Drug: Placebos |
| Placebo | Placebo comparator | Participants in the Placebo group received spray and oral placebos. 24 IU saline (spray placebo) 187.5 mg calcium carbonate (oral placebo) Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Belief update value for self, friend and stranger
In the vicarious optimistic bias task, participants would make first estimation about the happening likelihood for each event for themselves, friend, and stranger and then receive feedback about the general likelihood of each event happened in future. After all events first estimation, participants would estimate all the event again. So, for the belief update, we used the second estimation value to minus the first estimation value to get the update value, as well as calculating the update value in desirable condition (first estimation < feedback) and undesirable condition (first estimation < feedback). Then investigated the general belief updating (gBU) and optimistic belief updating (using desirableBU-undesirableBU) for the three target (self vs. friend vs. stranger) in three treatment groups (Oxytocin vs. L-DOPA vs. Placebo)
Measured: 40~70 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Dec 2018
- Primary completion15 Jan 2019
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxytocin 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, ma, yina, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891095
- Sponsor's protocol ID
- OT-DA-Vicarious optimism
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 26 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 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin and Dopamine's Effect on Vicarious Optimism
- ClinicalTrials.gov ID
- NCT03891095
- Acronym / sponsor ID
- OT-DA-Vicarious optimism
- Conditions
- Oxytocin Group, L-DOPA Group, Placebo Group
- Keywords
- intranasal oxytocin, L-DOPA, Vicarious optimism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 26 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.
To investigate the effect of intranasal Oxytocin and L-DOPA's effect on vicarious optimism.
Detailed description
The current study adopted a double-blind, double-dummy, placebo-controlled mixed design, with Treatment (oxytocin, dopamine, and placebo) as a between-subjects factor, and Target (self, friend, and an identifiable stranger) and Feedback (desirable vs. undesirable) as within-subjects factors. Upon arrival, participants first completed a set of questionnaires, including mood measurements and other questionnaires related to optimistic or prosocial tendency. Participants then self-administered with the pharmacological challenge 40 min before the main task, i.e., the belief updating task where participants indicated and updated their beliefs about the future of oneself, a gender-matched best friend, and a gender-matched identifiable stranger. At the end, participants completed the mood measurement again, as well the debriefing questionnaires which designed to measure their beliefs about the experimental process.
For the vicarious optimism task, participants completed three blocks of the two-session belief updating task where they were asked to estimate the likelihood of adverse life events happening to three targets: themselves (referred as Self), a gender-matched best friend (referred as Friend), and an identifiable stranger (whose name, brief description and picture were presented to the participants to get familiar with before the estimation, such as "The stranger is Zhexing, a 25-year-old male, Chinese"; referred as Stranger).
Participants completed two estimation sessions for one target before beginning with the next target, and the order of targets was counterbalanced across participants within each group. For the first session of each target block, participants were first presented with 30 different adverse life events (in a random order) and estimated the likelihood of each event happening to the target in the future (the 1st estimation, referred to as E1) on a self-paced basis. Participants were then presented with the probability of each event occurring to an average person in a similar environment (Feedback) for 2s. In the second session, participants estimated the likelihood of the same 30 events (in a random order) happening to the target person again without receiving feedback (the 2nd estimation, referred to as E2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal oxytocin | Experimental | Drug: Oxytocin, Drug: PlacebosOxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (24 IU or 40.32 mg; Syntocinon-spray; Novartis, Switzerland) |
| L-DOPA | Experimental | Drug: L-DOPA, Drug: PlacebosL-DOPA, a neuropeptide who is a key modulator of complex socioaffective responses including reward, social decision making, learning. Subjects receiving 187.5 mg Madopar (L-DOPA treatment, including 150 mg L-3,4-dihydroxyphenylalanine, together with 37.5 mg benserazide, which promotes higher levels of dopamine in the brain while minimizing side effects from peripheral dopamine) |
| Placebo | Placebo comparator | Drug: PlacebosParticipants in the Placebo group received spray and oral placebos. 24 IU saline (spray placebo) 187.5 mg calcium carbonate (oral placebo) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (1 listed)
- subjects with past or current psychiatric or neurological disorders
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 |
|---|---|---|
| Oxytocinintranasally administrated | Drug | Intranasal oxytocin |
| L-DOPAorally administered | Drug | L-DOPA |
| Placebosintranasally administrated and orally administered | Drug | Intranasal oxytocin, L-DOPA, Placebo |
Primary outcome
Belief update value for self, friend and stranger
Time frame: 40~70 minutes after drug administration
In the vicarious optimistic bias task, participants would make first estimation about the happening likelihood for each event for themselves, friend, and stranger and then receive feedback about the general likelihood of each event happened in future. After all events first estimation, participants would estimate all the event again. So, for the belief update, we used the second estimation value to minus the first estimation value to get the update value, as well as calculating the update value in desirable condition (first estimation < feedback) and undesirable condition (first estimation < feedback). Then investigated the general belief updating (gBU) and optimistic belief updating (using desirableBU-undesirableBU) for the three target (self vs. friend vs. stranger) in three treatment groups (Oxytocin vs. L-DOPA vs. Placebo)
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 26 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 Oxytocin and L-DOPA in people with Oxytocin Group and L-DOPA 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 26 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?
Belief update value for self, friend and stranger (time frame: 40~70 minutes after drug administration). 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 26 Mar 2019.