NCT02523664

Brief Summary

To investigate which neuronal correlates underlie cortisol-induced enhancement of memory retrieval in PTSD and BPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 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

January 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4.9 years

First QC Date

August 7, 2015

Last Update Submit

February 4, 2019

Conditions

Borderline Personality DisorderPTSD

Outcome Measures

Primary Outcomes (1)

  • brain activation after hydrocortisone

    fMRI

    20 min

Secondary Outcomes (2)

  • memory retrieval after hydrocortisone

    10 minutes

  • memory retrieval after hydrocortisone

    20 minutes

Study Arms (2)

Hydrocortisone

ACTIVE COMPARATOR

10 mg hydrocortisone orally

Drug: Hydrocortisone

Placebo

PLACEBO COMPARATOR

placebo orally

Drug: Placebo

Interventions

HydrocortisoneDRUG

effects of hydrocortisone on memory while fMRI

Hydrocortisone
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Borderline Personality Disorder
  • Clinical diagnosis of PTSD
  • females without psychiatric disorders as control group
  • right handed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Conditions

Borderline Personality DisorderStress Disorders, Post-Traumatic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 14, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

DE(1)