Effects of Hydrocortisone on Social Cognition and Memory | NCT02478021

Studies
Effects of Hydrocortisone on Social Cognition and Memory

NCT02478021

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jun 23, 2015Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Individuality

Interventions

Hydrocortisone

Countries

Germany

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

Jun 2015

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

Sep 2014

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jun 11, 2015

First Submission Date that Met QC Criteria

Jun 18, 2015

First Posted Date

Jun 23, 2015Estimated

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

Jun 18, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katja Wingenfeld, PhD, Head: Clinical Psycology, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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

The effects of hydrocortisone on cognition will be investigated.

Detailed Description

80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 10 mg hydrocortisone before testing. Tasks will on emotion recognition, memory and cognitive flexibilty will be conducted.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrocortisone	Experimental	10 mg hydrocortisone	Other: Hydrocortisone
Placebo	Placebo Comparator	1 pill Placebo	Other: Hydrocortisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrocortisone	Other	Effects of hydrocortisone compared to placebo on cognition	Hydrocortisone Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
social cognition	computer based test: Multifaceted Empaty test	25 min

Secondary Outcomes

Measure	Description	Time Frame
memory	autobiographic memory test (AMT)	25 min
cognitive flexibilty	computer based test: task switch	10 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 - 30
medication free

Exclusion Criteria:

any medication
severe ilness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katja Wingenfeld	Charite University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University		Berlin			Germany

Intervention Browse Module

MeSH Terms

ID	Term
D006854	Hydrocortisone

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided