NCT02552654

Brief Summary

Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether cortisol levels during an intrusion-inducing stressor influence subsequent intrusive memories.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

September 16, 2015

Last Update Submit

September 30, 2016

Conditions

Intrusive Memories

Outcome Measures

Primary Outcomes (1)

  • Number of intrusive memories

    Measured with an intrusion diary

    seven consecutive days

Secondary Outcomes (2)

  • Vividness of intrusive memories

    seven consecutive days

  • Degree of distress of intrusive memories

    seven consecutive days

Study Arms (2)

Hydrocortisone and Stress Film

EXPERIMENTAL

Administration of 10mg hydrocortisone before the trauma film.

Behavioral: Stress FilmDrug: Hydrocortisone

Placebo and Stress Film

EXPERIMENTAL

Administration of placebo before the trauma film.

Behavioral: Stress FilmDrug: Placebo

Interventions

Stress FilmBEHAVIORAL

Film scene with severe physical and sexual violence.

Hydrocortisone and Stress FilmPlacebo and Stress Film
HydrocortisoneDRUG

10mg

Hydrocortisone and Stress Film
PlaceboDRUG
Placebo and Stress Film

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy participants
  • German on a native level

You may not qualify if:

  • former or present DSM IV Axis I disorders
  • physical illnesses
  • any medication intake (except oral contraceptive)
  • history of sexual abuse or rape
  • pregnancy or lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hydrocortisone

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Stefan Roepke

    Charite University, Berlin, Germany

    STUDY DIRECTOR

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
Dipl.-Psych.

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 17, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

October 3, 2016

Record last verified: 2016-09