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

NCT01108133 | Completed DMC

• 2 other identifiers: GC-fMRI-PTSDGC-fMRI-PTSD-2010
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Traumatic Memories; fMRI

Outcome Measures

Primary Outcomes (1)

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

  May 2010-Sept 2011

Secondary Outcomes (1)

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

  may 2010-Sept. 2011

Study Arms (3)

Hydrocortisone, fMRI, Intrusions

EXPERIMENTAL

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

Dexamethasone, fMRI, Intrusions

EXPERIMENTAL

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

Placebo, fMRI, Intrusions

EXPERIMENTAL

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

10 mg HydrocortisoneHöchst DRUG

10 mg Hydrocortisone Höchst are administered one hour before fMRI scanning

Also known as: HydrocortisoneHöchst

Hydrocortisone, fMRI, Intrusions

Dexamethasone DRUG

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

Dexamethasone, fMRI, Intrusions

Placebo DRUG

Placebo

Placebo, fMRI, Intrusions

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

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

Mannheim, Baden Württemberg6, 68159, Germany

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Christian Schmahl, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 21, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 2, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)