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Trial record 23 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Borderline Personality Disorder"

Neural Correlates of Stress Hormones (Cort-fMRI)

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ClinicalTrials.gov Identifier: NCT02523664
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Katja Wingenfeld, Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder PTSD Drug: Hydrocortisone Drug: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : January 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Active Comparator: Hydrocortisone
10 mg hydrocortisone orally
Drug: Hydrocortisone
effects of hydrocortisone on memory while fMRI

Placebo Comparator: Placebo
placebo orally
Drug: Placebo



Primary Outcome Measures :
  1. brain activation after hydrocortisone [ Time Frame: 20 min ]
    fMRI


Secondary Outcome Measures :
  1. memory retrieval after hydrocortisone [ Time Frame: 10 minutes ]
    Retrieval of a previous learned word list

  2. memory retrieval after hydrocortisone [ Time Frame: 20 minutes ]
    autobiographic memory retrieval



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523664


Locations
Germany
Charite University Recruiting
Berlin, Germany
Contact: Katja Wingenfeld, PhD    004930450517534    katja.wingenfeld@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany

Responsible Party: Katja Wingenfeld, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02523664     History of Changes
Other Study ID Numbers: WI-3396-2
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents