Neural Correlates of Stress Hormones (Cort-fMRI)
Primary Purpose
Borderline Personality Disorder, PTSD
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hydrocortisone
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Borderline Personality Disorder
- Clinical diagnosis of PTSD
- females without psychiatric disorders as control group
- right handed
Exclusion Criteria:
- fMRI exclusion criteria e.g. metal implants, pregnancy, left-handedness, and claustrophobia.
Sites / Locations
- Charite University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hydrocortisone
Placebo
Arm Description
10 mg hydrocortisone orally
placebo orally
Outcomes
Primary Outcome Measures
brain activation after hydrocortisone
fMRI
Secondary Outcome Measures
memory retrieval after hydrocortisone
Retrieval of a previous learned word list
memory retrieval after hydrocortisone
autobiographic memory retrieval
Full Information
NCT ID
NCT02523664
First Posted
August 7, 2015
Last Updated
February 4, 2019
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT02523664
Brief Title
Neural Correlates of Stress Hormones
Acronym
Cort-fMRI
Official Title
Why Does Cortisol Enhance Memory Retrieval in Patients With Borderline Personality Disorder and Posttraumatic Stress Disorder? Investigating the Neuronal Correlates of Cortisol Administration and the Effects of Stress Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate which neuronal correlates underlie cortisol-induced enhancement of memory retrieval in PTSD and BPD.
Detailed Description
The investigators have recently shown that hydrocortisone enhances rather than impairs memory retrieval in patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD). In contrast, in healthy participants memory retrieval was impaired after hydrocortisone compared to placebo.
The proposed studies aim to further investigate these findings and to understand the underlying neuronal correlates. Thus, the mechanisms of enhanced memory retrieval after hydrocortisone in patients with BPD and PTSD will be investigated by fMRI.
In a placebo-controlled study, the effects of 10mg hydrocortisone on brain activity, in particular the hippocampus, will be investigated in patients with PTSD and BPD and will be compared with those in healthy control participants. During the fMRI session, a declarative memory task (retrieval of a previous learned word list) and an autobiographical memory test will be performed. Effects of hydrocortisone on resting state brain activity and the neuronal correlates of memory retrieval will be analysed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, PTSD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrocortisone
Arm Type
Active Comparator
Arm Description
10 mg hydrocortisone orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo orally
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
effects of hydrocortisone on memory while fMRI
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
brain activation after hydrocortisone
Description
fMRI
Time Frame
20 min
Secondary Outcome Measure Information:
Title
memory retrieval after hydrocortisone
Description
Retrieval of a previous learned word list
Time Frame
10 minutes
Title
memory retrieval after hydrocortisone
Description
autobiographic memory retrieval
Time Frame
20 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Borderline Personality Disorder
Clinical diagnosis of PTSD
females without psychiatric disorders as control group
right handed
Exclusion Criteria:
fMRI exclusion criteria e.g. metal implants, pregnancy, left-handedness, and claustrophobia.
Facility Information:
Facility Name
Charite University
City
Berlin
Country
Germany
12. IPD Sharing Statement
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Neural Correlates of Stress Hormones
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