HealthyNMCARSEHHSCNCT02799134
Neural Mechanism of Cortisol Awakening Response Suppression Effect on Human High-order and Social Cognitions
A study testing Dexamethasone and Vitamin C in people with Healthy, run by qinshaozheng at 1 site in China.
Trial summary
CAR is short for cortisol awakening response. The neural mechanism of CAR effect on high-order cognition and social cognition is less known... Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dexamethasone and Vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to 30 Apr 2017
- 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 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy college students.
Who cannot join
- Current or history of psychiatric or neurological illness.
- Current use of any medications.
Trial locations and contacts
1 site in 1 country.
About this study
CAR is short for cortisol awakening response. The neural mechanism of CAR effect on high-order cognition and social cognition is less known...
- Conditions
- Healthy
- Being tested
- Dexamethasone, Vitamin C
- Keywords
- Cortisol Awakening Response suppression, Dexamethasone Suppression Test, high-order cognition, social cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Vitamin CDrug
| Study group | Role | What they receive |
|---|---|---|
| group1 | Experimental | take Dexamethasone at 22:00 on the first day, 0.5mg Receives: Drug: Dexamethasone |
| group2 | Placebo comparator | take Vitamin C at 22:00 on the first day, 0.5mg Receives: Drug: Vitamin C |
| group3 | Other | take Dexamethasone at 15:00 on the second day, 0.5mg Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol Awakening Response Level(nmol/L) after Taking Dexamethasone
The dosage of Dexamethasone is 0.5mg.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startNov 2015
- Primary completion10 Apr 2017
- Study completion30 Apr 2017
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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- qinshaozheng
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences, Xuanwu Hospital, Beijing
- Responsible party
- Sponsor-investigator, qinshaozheng, Beijing Normal University
- Investigators
- Shaozheng Qin, Doctor, Study chair, Beijing Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799134
- Sponsor's protocol ID
- ICBIR_A_0098_002
- Acronym
- NMCARSEHHSC
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2016
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanism of Cortisol Awakening Response Suppression Effect on Human High-order and Social Cognitions
- ClinicalTrials.gov ID
- NCT02799134
- Acronym / sponsor ID
- NMCARSEHHSC / ICBIR_A_0098_002
- Conditions
- Healthy
- Keywords
- Cortisol Awakening Response suppression, Dexamethasone Suppression Test, high-order cognition, social cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- qinshaozhengUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences, Xuanwu Hospital, Beijing
- Study start
- Nov 2015 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 14 Jun 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.
CAR is short for cortisol awakening response. The neural mechanism of CAR effect on high-order cognition and social cognition is less known...
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group1 | Experimental | Drug: Dexamethasonetake Dexamethasone at 22:00 on the first day, 0.5mg |
| group2 | Placebo comparator | Drug: Vitamin Ctake Vitamin C at 22:00 on the first day, 0.5mg |
| group3 | Other | Drug: Dexamethasonetake Dexamethasone at 15:00 on the second day, 0.5mg |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy college students.
Key exclusion criteria (2 listed)
- Current or history of psychiatric or neurological illness.
- Current use of any 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 |
|---|---|---|
| Dexamethasone | Drug | group1, group3 |
| Vitamin C | Drug | group2 |
Primary outcome
Cortisol Awakening Response Level(nmol/L) after Taking Dexamethasone
Time frame: one year
The dosage of Dexamethasone is 0.5mg.
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 22 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Shaozheng Qin, Doctor study chair
Beijing Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Vitamin C in people with Healthy, run by qinshaozheng 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 2 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 22 Apr 2022. 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?
Cortisol Awakening Response Level(nmol/L) after Taking Dexamethasone (time frame: one year). 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 22 Apr 2022.