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CompletedNCT01108133Updated Jul 2, 2017

Neural and Pharmacological Correlates of Intrusions in Patients With Posttraumatic Stress Disorder

An interventional study of 10 mg HydrocortisoneHöchst and Dexamethasone in Posttraumatic Stress Disorder, sponsored by Central Institute of Mental Health, Mannheim. Completed at 1 site in Germany. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by Central Institute of Mental Health, Mannheim · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

There is evidence that glucocorticoids have an impact on intrusive memories in patients with posttraumatic stress disorder (PTSD). Hydrocortisone impairs intrusive memory retrieval whereas dexamethasone should strengthen intrusions in PTSD. We, the investigators, want to investigate (1) the effect of these two glucocorticoids on traumatic memories and (2) assess the neural correlates using the script-driven imagery paradigm in the functional magnetic resonance imaging (fMRI) scanner. We hypothesize that intrusive memories are less intensive under hydrocortisone-administration and more intense under dexamethasone-administration comparing both to a placebo-condition. Regarding the neural activation pattern we expect higher activation in the hydrocortisone condition in the amygdala, the hippocampus and the medial prefrontal cortex compared to the placebo-condition and less activation in the dexamethasone-condition compared to the placebo-condition.

Read the detailed description

There is evidence that glucocorticoids have an impact on intrusive memories in patients with posttraumatic stress disorder (PTSD). Hydrocortisone impairs intrusive memory retrieval whereas dexamethasone should strengthen intrusions in PTSD. We, the investigators, want to investigate (1) the effect of these two glucocorticoids on traumatic memories and (2) assess the neural correlates using the script-driven imagery paradigm in the functional magnetic resonance imaging (fMRI) scanner. Therefore an individual trauma-and an individual neutral -script is assessed from each participant, recorded and replayed during fMRI-scanning. We hypothesize that intrusive memories are less intense under hydrocortisone-administration and more intense under dexamethasone-administration comparing both to a placebo-condition. Regarding the neural activation pattern we expect higher activation in the hydrocortisone condition in the amygdala, the hippocampus and the medial prefrontal cortex compared to the placebo-condition and less activation in the dexamethasone-condition compared to the placebo-condition.

02

Conditions studied

  • Posttraumatic Stress Disorder

Keywords

  • Posttraumatic Stress Disorder
  • Traumatic Memories
  • fMRI
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 13 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

Central Institute of Mental Health, Mannheim is the lead sponsor of 59 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age: 18-45
  • Female
  • Posttraumatic Stress Disorder assessed by the Structured Clinical Interview (SKID-I)
  • Intrusive memories (Impact of Events Scale - Revised [IES-R] intrusion scale > 7)

Exclusion criteria

Exclusion Criteria:

    • Lifetime diagnosis schizophrenia according to Diagnostic and Statistical Manual, Fourth Edition (DSM-IV)

      • Mental retardation
      • Body mass index \< 16.5
      • Current drug and alcohol abuse and addiction
      • Life-threatening self-injurious behavior in the last 4 months
      • Suicide attempt with the strong intention to die in the last 4 months.
      • Following diseases in anamnesis: stomach ulcera or intestinal ulcera, pancreatitis, corticoid-induced psychosis, severe osteoporosis, severe hyper-tension, heart failure, myasthenia gravis, asthma bronchiale, glaucoma, cataract, diabetes mellitus, herpes simples, herpes zoster (viremic phase), renal transplantation.
      • Any pretreatment with hydrocortisone in the last 4 weeks prior to the first administration of Investigational Medicinal Product.
      • Following current medication: cardiac glycosides, saluretics, antidiabetics, cumarin-derivatives, rifampicine, phenytoine, barbiturates, primidone, non-steroidal anti-inflammatory drug (NSAID), salicylate and indometacine, atropine, praziquantel, chloroquine, hydroxychloroquine, mefloquine, somatropine, protireline, cyclosporine, non-depolarising muscle relaxants.
      • Pregnancy or lactation period
      • Inadequate birth control
      • Shift working
      • Intercontinental travel within 2 weeks prior to enrollment (to avoid jet-lag)
      • History of hypersensitivity to investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
      • No subject will be allowed to enrol in this trial more than once.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Hydrocortisone, fMRI, Intrusions

    10 mg Hydrocortisone are administered one hour before the fMRI experiment. We use the script-driven imagery paradigm to induce intrusive memories during fMRI scanning.

    Drug: 10 mg HydrocortisoneHöchst

  • Experimental
    Dexamethasone, fMRI, Intrusions

    2 mg Dexamethasone are administered at 10 pm the day before the fMRI experiment. (DEX-Test). We use the script-driven imaging paradigm to induce intrusive memories during fMRI-scanning.

    Drug: Dexamethasone

  • Experimental
    Placebo, fMRI, Intrusions

    Placebo is administered one hour before the fMRI experiment. We use the script-driven imaging paradigm to induce intrusive memories during fMRI-scanning in patients with posttraumatic stress disorder.

    Drug: Placebo

Interventions

  • Drug10 mg HydrocortisoneHöchst

    10 mg Hydrocortisone Höchst are administered one hour before fMRI scanning

    Also known as: HydrocortisoneHöchst

  • DrugDexamethasone

    2 mg Dexamethasone are administered at 10 pm the day before the fMRI experiment.

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Neural activation pattern of intrusive memories in patients with posttraumatic stress disorder under administration of hydrocortisone, dexamethasone and placebo.

    Time frame: May 2010-Sept 2011

Secondary outcomes

  1. Intensity of intrusions under the administration of hydrocortisone, dexamethasone and placebo.

    Time frame: may 2010-Sept. 2011

07

Study locations

1 site
  • Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
    Mannheim, Baden Württemberg6 68159, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01108133
Lead sponsor
Central Institute of Mental Health, Mannheim
Responsible party
Sponsor
First posted
Apr 21, 2010
Start date
Oct 2010
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jul 2, 2017

Study contacts

Christian Schmahl, MD
principal investigator · Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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