Oxytocin Effect on Memory Performance During Phase 1Phase 1NCT02745522
Can Oxytocin Enhance the Placebo Effect?
A Phase 1 study testing Oxytocin in people with Oxytocin Effect on Memory Performance During Phase 1 and Oxytocin Effect on Memory Performance During Phase 2, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The current study aimed to investigate whether oxytocin (OXT) had effect on placebo effect. 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
- Oxytocin Effect on Memory Performance During Phase 1, Oxytocin Effect on Memory Performance During Phase 2, Oxytocin Effect on Memory Performance During Phase 3
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Aug 2017
- Phase
- Phase 1
- 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 disorder
Who cannot join
- history of head injury;
- claustrophobia;
- medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Life Science and Technology, University of Electronic Science and Technology
Chengdu, Sichuan, 611731
About this study
The current study aimed to investigate whether oxytocin (OXT) had effect on placebo effect.
Read the detailed description
The current study included three phases to investigate oxytocin effect on placebo effect:
- In a double-blind, between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 66 healthy male subjects using working memory task.
- In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task.They were informed that oxytocin would increase memory perfomance by a female experimenter.
- In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task. But the subjects were told that oxytocin would decrease the performance by the same female experimenter.
- In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 52 healthy male subjects using working memory task. The subjects were told that oxytocin would increase the performance by a male experimenter.
Memory performance was included as dependant factor. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety: State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Interpersonal Trust Scale(ITS).
- Conditions
- Oxytocin Effect on Memory Performance During Phase 1, Oxytocin Effect on Memory Performance During Phase 2, Oxytocin Effect on Memory Performance During Phase 3, Oxytocin Effect on Memory Performance During Phase 4
- Being tested
- Oxytocin, Placebo
- Keywords
- Placebo effect, Working memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin nasal spray Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo nasal spray Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory performance in different phases
N-back memory performance (accuracy) was included into analysis.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxytocin Effect on Memory Performance During Phase 1Studies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 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, Keith Kendrick, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745522
- Sponsor's protocol ID
- UESTC-neuSCAN-07
- Status last verified
- Oct 2018
- First submitted
- 11 Mar 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Oxytocin Enhance the Placebo Effect?
- ClinicalTrials.gov ID
- NCT02745522
- Acronym / sponsor ID
- UESTC-neuSCAN-07
- Conditions
- Oxytocin Effect on Memory Performance During Phase 1, Oxytocin Effect on Memory Performance During Phase 2, Oxytocin Effect on Memory Performance During Phase 3, Oxytocin Effect on Memory Performance During Phase 4
- Keywords
- Placebo effect, Working memory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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 investigate whether oxytocin (OXT) had effect on placebo effect.
Detailed description
The current study included three phases to investigate oxytocin effect on placebo effect:
- In a double-blind, between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 66 healthy male subjects using working memory task.
- In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task.They were informed that oxytocin would increase memory perfomance by a female experimenter.
- In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task. But the subjects were told that oxytocin would decrease the performance by the same female experimenter.
- In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 52 healthy male subjects using working memory task. The subjects were told that oxytocin would increase the performance by a male experimenter.
Memory performance was included as dependant factor. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety: State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Interpersonal Trust Scale(ITS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinOxytocin nasal spray |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo nasal spray |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorder
Key exclusion criteria (3 listed)
- history of head injury;
- claustrophobia;
- medical or psychiatric illness.
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 |
|---|---|---|
| Oxytocin | Drug | Oxytocin |
| Placebo | Drug | Placebo |
Primary outcome
Memory performance in different phases
Time frame: 1 hour
N-back memory performance (accuracy) was included into analysis.
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 15 Oct 2018.
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 Phase 1 study testing Oxytocin in people with Oxytocin Effect on Memory Performance During Phase 1 and Oxytocin Effect on Memory Performance During Phase 2, 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 1 inclusion and 3 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 15 Oct 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Memory performance in different phases (time frame: 1 hour). 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 15 Oct 2018.