Borderline Personality DisorderCort-fMRINCT02523664
Neural Correlates of Stress Hormones
A study testing Hydrocortisone in people with Borderline Personality Disorder and PTSD, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
To investigate which neuronal correlates underlie cortisol-induced enhancement of memory retrieval in PTSD and BPD. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, PTSD
- What is being tested?
- Hydrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of Borderline Personality Disorder
- Clinical diagnosis of PTSD
- females without psychiatric disorders as control group
- right handed
Who cannot join
- fMRI exclusion criteria e.g. metal implants, pregnancy, left-handedness, and claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
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
To investigate which neuronal correlates underlie cortisol-induced enhancement of memory retrieval in PTSD and BPD.
Read the 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.
- Conditions
- Borderline Personality Disorder, PTSD
- Being tested
- Hydrocortisone, Placebo
- Medical subject headings
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
effects of hydrocortisone on memory while fMRI
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Active comparator | 10 mg hydrocortisone orally Receives: Drug: Hydrocortisone |
| Placebo | Placebo comparator | placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain activation after hydrocortisone
fMRI
Measured: 20 min
Secondary outcomes (2)
memory retrieval after hydrocortisone
Retrieval of a previous learned word list
Measured: 10 minutes
memory retrieval after hydrocortisone
autobiographic memory retrieval
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Wingenfeld, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523664
- Sponsor's protocol ID
- WI-3396-2
- Acronym
- Cort-fMRI
- Status last verified
- Feb 2019
- First submitted
- 7 Aug 2015
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02523664
- Acronym / sponsor ID
- Cort-fMRI / WI-3396-2
- Conditions
- Borderline Personality Disorder, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Active comparator | Drug: Hydrocortisone10 mg hydrocortisone orally |
| Placebo | Placebo comparator | Drug: Placeboplacebo orally |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Borderline Personality Disorder
- Clinical diagnosis of PTSD
- females without psychiatric disorders as control group
- right handed
Key exclusion criteria (1 listed)
- fMRI exclusion criteria e.g. metal implants, pregnancy, left-handedness, and claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisoneeffects of hydrocortisone on memory while fMRI | Drug | Hydrocortisone |
| Placebo | Drug | Placebo |
Primary outcome
brain activation after hydrocortisone
Time frame: 20 min
fMRI
2 secondary outcomes
memory retrieval after hydrocortisone
Time frame: 10 minutes
memory retrieval after hydrocortisone
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Related trials for Borderline Personality Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
RecruitingPhase 2
MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone in people with Borderline Personality Disorder and PTSD, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain activation after hydrocortisone (time frame: 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.