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

This study is currently recruiting participants.
Verified January 2013 by Central Institute of Mental Health, Mannheim
Sponsor:
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT01108133
First received: April 20, 2010
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
 Drug: 10 mg HydrocortisoneHöchst
Drug: Dexamethasone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Neural and Pharmacological Correlates of Intrusions in Patients With Posttraumatic Stress Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity of intrusions under the administration of hydrocortisone, dexamethasone and placebo. [ Time Frame: may 2010-Sept. 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
10 mg Hydrocortisone Höchst are administered one hour before fMRI scanning
Other Name: 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
2 mg Dexamethasone are administered at 10 pm the day before the fMRI experiment.
Other Name: 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
Placebo
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108133

Contacts
Contact: Petra Ludäscher, Post Doc +49 621 17034421 Petra.Ludaescher@zi-mannheim.de
Contact: Christian Schmahl, MD +49 621 17034401 Christian.Schmahl@zi-mannheim.de

Locations
Germany
Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine Recruiting
Mannheim, Baden Württemberg6, Germany, 68159
Contact: Petra Ludäscher, PostDoc     +49 621 17034421     Petra.Ludaescher@zi-mannheim.de    
Contact: Christian Schmahl, MD     +49 621 17034401     Christian.Schmahl@zi-mannheim.de    
Principal Investigator: Christian Schmahl, MD            
Sub-Investigator: Petra Ludäscher, PostDoc            
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Investigators
Principal Investigator: Christian Schmahl, MD Central Institute of Mental Health, Dep. of Psychosomatic and Psychotherapeutic Medicine
  More Information

No publications provided

Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT01108133     History of Changes
Other Study ID Numbers: GC-fMRI-PTSD, GC-fMRI-PTSD-2010
Study First Received: April 20, 2010
Last Updated: January 29, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Central Institute of Mental Health, Mannheim:
Posttraumatic Stress Disorder
Traumatic Memories
fMRI

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Dexamethasone
Hydrocortisone
Dexamethasone 21-phosphate
BB 1101
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013