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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01108133
Enrollment
13
Registered
2010-04-21
Start date
2010-10-31
Completion date
2013-03-31
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder, Traumatic Memories, fMRI

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.

Interventions

DRUG10 mg HydrocortisoneHöchst

10 mg Hydrocortisone Höchst are administered one hour before fMRI scanning

DRUGDexamethasone

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

DRUGPlacebo

Placebo

Sponsors

Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

* • 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.

Design outcomes

Primary

MeasureTime frame
Neural activation pattern of intrusive memories in patients with posttraumatic stress disorder under administration of hydrocortisone, dexamethasone and placebo.May 2010-Sept 2011

Secondary

MeasureTime frame
Intensity of intrusions under the administration of hydrocortisone, dexamethasone and placebo.may 2010-Sept. 2011

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026