Effects of Mineralocorticoid Receptor Stimulation on Cogn... | NCT02478034

Studies
Effects of Mineralocorticoid Receptor Stimulation on Cognition

NCT02478034

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Mar 7, 2016Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Individuality

Interventions

Fludrocortisone

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

Mar 2016

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

May 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

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

Mar 4, 2016

Last Update Posted Date

Mar 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katja Wingenfeld, Prof. Dr., Head: Clinical Psychology, 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

In this study the effects of mineralocorticoid stimulation on social cognition will be investigated in healthy young individuals.

Detailed Description

80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 0.4 mg Fludrocortison before testing. Tasks will on emotion recognition, Task Switch, visual spacial memory and decision making 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
fludrocortisone	Experimental	effects of fludrocortisone on cognition compared to placebo	Other: Fludrocortisone
Placebo	Placebo Comparator	effects of fludrocortisone on cognition compared to placebo	Other: Fludrocortisone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fludrocortisone	Other	effects of fludrocortisone on cognition compared to placebo	Placebo fludrocortisone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
social cognition	computer based tests: emotion recognition	25 min

Secondary Outcomes

Measure	Description	Time Frame
memory	computer based test on visuospacial memory	20 min
decision making	computer based tests: BART	25 min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

free of medication
age 18 - 30

Exclusion Criteria:

any medication
severe illness

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, PhD	Charité University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University		Berlin			Germany

Intervention Browse Module

MeSH Terms

ID	Term
D005438	Fludrocortisone
C034635	fludrocortisone acetate

Ancestor Terms

ID	Term
D006854	Hydrocortisone
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes

Browse Leaves

Not provided

Browse Branches

Not provided