Posttraumatic Stress Disorder
Conditions
Brief summary
To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.
Interventions
DRUGArm 1 Hydrocortisone 10 mg
Group 1: Administration of Hydrocortisone and/or Placebo in the following order: 1 week placebo- 1 week 10 mg hydrocortisone - 1 week placebo - 1 week 30 mg hydrocortisone
DRUGArm 2 Hydrocortisone 30 mg
Drug: Hydrocortisone 30 mg Group 2: Administration of Hydrocortisone and/or Placebo in the following order: 1 week hydrocortisone 30 mg/d- 1 week placebo - 1 week hydrocortisone 10 mg/d - 1 week placebo
Sponsors
German Research Foundation
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Written Informed Consent * Female patients with PTSD according to DSM-IV criteria (see Appendix 2). * 18-45 years * Intrusions (according to IES-R subscale Intrusions: Value: \> 7 * Ability of subject to understand character and individual consequences of the clinical trial * No participation in another clinical trial (up from 30 days before this trial)
Exclusion criteria
* Lifetime diagnosis schizophrenia according to 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 Investiga-tional Medicinal Product. * Following current medication: cardiac glycosides, saluretics, antidiabetics, cumarin-derivatives, rifampicine, phenytoine, barbiturates, primidone, NSAID, salicylate and indometacine, atropine, praziquantel, chloroquine, hydroxychloroquine, mefloquine, somatropine, protireline, cyclosporine, non-depolarising muscle relaxants. * Pregnancy or lactation period * Inadequate birth control (Adequate birth control: implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner) * 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
| Measure | Time frame |
|---|---|
| Reduction of the frequency and intensity of intrusions assessed with the subscale Intrusions of the Impact of Event Scale (IES-R) | 4 Years |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of the overall PTSD symptomatology assessed with the IES-R and the Posttraumatic Diagnostic Scale (PDS) | 4 Years |
Countries
Germany
Outcome results
None listed