NCT02478034

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

June 11, 2015

Last Update Submit

March 4, 2016

Conditions

Individuality

Outcome Measures

Primary Outcomes (1)

  • social cognition

    computer based tests: emotion recognition

    25 min

Secondary Outcomes (2)

  • memory

    20 min

  • decision making

    25 min

Study Arms (2)

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

FludrocortisoneOTHER

effects of fludrocortisone on cognition compared to placebo

Also known as: Florinef (Squibb & Sons Limited)
Placebofludrocortisone

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • free of medication
  • age 18 - 30

You may not qualify if:

  • any medication
  • severe illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Interventions

Fludrocortisonefludrocortisone acetate

Intervention Hierarchy (Ancestors)

HydrocortisonePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Katja Wingenfeld, PhD

    Charité University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr., Head: Clinical Psychology

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 23, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

DE(1)