NCT02478021

Brief Summary

The effects of hydrocortisone on cognition will be investigated.

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 Sep 2014

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

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

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
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

June 11, 2015

Last Update Submit

June 18, 2015

Conditions

Individuality

Keywords

effects of cortisol on cognition

Outcome Measures

Primary Outcomes (1)

  • social cognition

    computer based test: Multifaceted Empaty test

    25 min

Secondary Outcomes (2)

  • memory

    25 min

  • cognitive flexibilty

    10 min

Study Arms (2)

Hydrocortisone

EXPERIMENTAL

10 mg hydrocortisone

Other: Hydrocortisone

Placebo

PLACEBO COMPARATOR

1 pill Placebo

Other: Hydrocortisone

Interventions

HydrocortisoneOTHER

Effects of hydrocortisone compared to placebo on cognition

HydrocortisonePlacebo

Eligibility Criteria

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

You may qualify if:

  • age 18 - 30
  • medication free

You may not qualify if:

  • any medication
  • severe ilness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Interventions

Hydrocortisone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Katja Wingenfeld

    Charite 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
PhD, Head: Clinical Psycology

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 23, 2015

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

DE(1)