Neural Mechanism of Cortisol Awakening Response Suppressi... | NCT02799134

Studies
Neural Mechanism of Cortisol Awakening Response Suppression Effect on Human High-order and Social Cognitions

NCT02799134

Sponsor

qinshaozheng

Status

Completed

Last Update Posted

Apr 22, 2022Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Dexamethasone
Vitamin C

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Apr 10, 2017Actual

Completion Date

Apr 30, 2017Actual

First Submitted Date

Apr 6, 2016

First Submission Date that Met QC Criteria

Jun 9, 2016

First Posted Date

Jun 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 22, 2022Actual

Name	Class
Chinese Academy of Sciences	OTHER_GOV
Xuanwu Hospital, Beijing	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

CAR is short for cortisol awakening response. The neural mechanism of CAR effect on high-order cognition and social cognition is less known...

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group1	Experimental	take Dexamethasone at 22:00 on the first day, 0.5mg	Drug: Dexamethasone
group2	Placebo Comparator	take Vitamin C at 22:00 on the first day, 0.5mg	Drug: Vitamin C
group3	Other	take Dexamethasone at 15:00 on the second day, 0.5mg	Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug		group1 group3
Vitamin C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cortisol Awakening Response Level(nmol/L) after Taking Dexamethasone	The dosage of Dexamethasone is 0.5mg.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy college students.

Exclusion Criteria:

Current or history of psychiatric or neurological illness.
Current use of any medications.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

26 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaozheng Qin, Doctor	Beijing Normal University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Normal University		Beijing	Beijing Municipality	100875	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided