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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
10 mg HydrocortisoneHöchst
Dexamethasone
Placebo
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Traumatic Memories, fMRI

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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:

  • • 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.

Sites / Locations

  • Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Hydrocortisone, fMRI, Intrusions

Dexamethasone, fMRI, Intrusions

Placebo, fMRI, Intrusions

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 20, 2010
Last Updated
June 28, 2017
Sponsor
Central Institute of Mental Health, Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT01108133
Brief Title
Neural and Pharmacological Correlates of Intrusions in Patients With Posttraumatic Stress Disorder
Official Title
Neural and Pharmacological Correlates of Intrusions in Patients With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Traumatic Memories, fMRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocortisone, fMRI, Intrusions
Arm Type
Experimental
Arm Description
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.
Arm Title
Dexamethasone, fMRI, Intrusions
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo, fMRI, Intrusions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
10 mg HydrocortisoneHöchst
Other Intervention Name(s)
HydrocortisoneHöchst
Intervention Description
10 mg Hydrocortisone Höchst are administered one hour before fMRI scanning
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
2 mg Dexamethasone are administered at 10 pm the day before the fMRI experiment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Intensity of intrusions under the administration of hydrocortisone, dexamethasone and placebo.
Time Frame
may 2010-Sept. 2011

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: • 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Schmahl, MD
Organizational Affiliation
Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
City
Mannheim
State/Province
Baden Württemberg6
ZIP/Postal Code
68159
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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